DEPARTMENT OF CONSUMER AND INDUSTRY SERVICES

                        RADIATION SAFETY SECTION


(By authority conferred on the department  of  public   health   by   section 
13521 of Act No. 368 of the Public Acts of 1978, as amended,  and  section 48 
of  Act  No. 306  of  the  Public   Acts   of   1969,   as   amended,   being 
SS333.13521 and 24.248 of the Michigan Compiled Laws)


                PART 7.  MEDICAL X-RAY INSTALLATIONS


R 325.5311.  Purpose and scope.
  Rule 311.  (1) This part establishes  requirements  governing  the  use  of 
x-radiation in medicine, osteopathy, chiropractic and podiatry.
  (2) This part applies to all licensees and registrants who use x- radiation 
in these healing arts disciplines for the intentional exposure of humans.
  (3) In addition to this part all licensees and registrants are  subject  to 
parts 1, 4 and 5 and all applicable provisions of the other parts.

   History: 1954 ACS 85, Eff. Dec. 3, 1975; 1954 ACS 98, Eff. Mar. 9, 1979.


                THERAPEUTIC MACHINES OPERATED ABOVE 85 KVP


R 325.5312. X-ray equipment.
  Rule 312.  (1) The tube housing shall be of the therapeutic type.
  (2) Permanent diaphragms or cones used  for  collimating  the  useful  beam 
shall afford the same degree of attenuation as is required of the housing.
  (3) Adjustable or removable beam-limiting devices shall transmit  not  more 
than 5% of the useful beam as determined at the maximum  tube  potential  and 
with maximum treatment filter.
  (4) Filters shall be so mounted as to prevent  their  movement  during  the 
treatment.
  (5) The filter slot shall be so constructed  that  the  radiation  escaping 
through it does not produce an exposure rate exceeding 1 R/h at 1  meter,  or 
if the patient is likely to be exposed to radiation escaping from  the  slot, 
30 R/h at 5 centimeters (2 inches) from the external opening.
  (6) A removable filter shall be permanently marked with its  thickness  and 
material.
  (7) A filter indication system shall be used on therapy machines which  use 
changeable filters and are manufactured after the  effective  date  of  these 
rules.  It shall indicate, from the control panel, the presence or absence of 
any filter and it shall be designed to permit easy recognition of the  filter 
in place.
  (8) The x-ray tube shall be so mounted that it cannot turn  or  slide  with 
respect to the housing aperture.  A reproducible means of measuring the focal 
spot to patient distance shall be provided.
  (9) Means to immobilize the tube housing during stationary portal treatment 
shall be provided.
  (10)  An easily discernible indicator which shows whether or not x-rays are 
being produced shall be on the control panel.
  (11)  On therapeutic machines manufactured  after  the  effective  date  of 
these rules beam monitoring devices shall be fixed  in  the  useful  beam  to 
indicate any error due to incorrect filter, tube current, or tube  potential, 
unless the device introduces more filtration than is clinically acceptable.
  (12)  A suitable exposure control device (e.g. an automatic timer, exposure 
meter or dose meter) shall be provided to  terminate  the  exposure  after  a 
preset time interval or preset exposure or dose limit.  If a timer  is  used, 
it shall permit accurate presetting and determination of  exposure  times  as 
short as 1 second.  Means for the operator to terminate the exposure  at  any 
time shall be provided.
  (13)  Mechanical or electrical stops or both shall be  provided  to  insure 
that the useful beam is oriented only toward primary barriers.
  (14)  Interlocks shall be provided so that, when any door to the  treatment 
room is opened, the machine will shut  off  automatically  or  the  radiation 
level within the room will be reduced to an average of not more than  2  mR/h 
and a maximum of 10 mR/h at a distance of 1 meter in any direction  from  the 
source.  After the shut-off or  reduction  in  exposure  rate,  it  shall  be 
possible to restore the machine to full operation only from the control panel.
  (15)  The x-ray control circuit  shall  be  so  designed  that  it  is  not 
possible to energize the x-ray tube to produce x-rays without  resetting  the 
x-ray "ON-OFF" switch at the control panel.
  (16)  When the relationship between the beam interceptor (when present) and 
the useful beam is not permanently  fixed,  mechanical  or  electrical  stops 
shall be provided to insure that the beam is  oriented  only  toward  primary 
barriers.
  (17)  X-ray equipment installed after the effective  date  of  these  rules 
shall be installed and used in accord with the appropriate  portions  of  the 
1975 national electrical code (NFPA No. 70-1975) reproduced or referenced  in 
rule 359.  X-ray equipment installed before the effective date of these rules 
shall conform with the appropriate national electrical code in effect at  the 
time of installation.
  (18)  X-ray machines with electron  beam  extraction  capability  shall  be 
provided with such additional safety  devices  as  determined  necessary  and 
specified in writing by the department to prevent  accidental  electron  beam 
exposure.
  (19)  To reduce the electron contamination of high energy treatment  beams, 
shadow trays or other accessories placed in the primary beam shall be  placed 
at a sufficient distance from the patient  that  the  electron  contamination 
contribution to the skin dose is minimal.
  (20)  X-ray machines capable of producing radioactive material in excess of 
exempt quantities listed in schedule B of rule 147 unless excluded  from  the 
particle accelerator definition in part 1 by design and use shall comply with 
the applicable requirements of part 11.

   History: 1954 ACS 85, Eff. Dec. 3, 1975; 1954 ACS 98, Eff. Mar. 9, 1979.


R 325.5315.  Enclosures.
  Rule 315.  (1) An enclosure shall be a permanent part of  the  building  or 
equipment.  Portable protective barriers shall  not  be  used  for  permanent 
installations.
  (2) The degree of protection required for an enclosure shall be  determined 
by  the  workload,  use  and   occupancy   factors   and   the   kilovoltage, 
milliamperage, mechanical movement, and distance factor, and shall be subject 
to design approval by the department.
  (3) All wall, ceiling and floor areas that can be irradiated by the  useful 
beam plus an additional area extending  at  least  30  centimeters  (1  foot) 
beyond shall be provided with a primary protective barrier.
  (4) For equipment capable of operating above 150 kVp  the  control  station 
shall be outside of the therapy room.
  (5) The enclosure shall be so constructed that persons may at all times  be 
able to escape from within.
  (6) If the radiation exposure rate within the therapy room is so high  that 
a person who is accidentally in the treatment room when the machine is turned 
"ON" may receive as much as 1250 mR exposure  during  the  time  required  to 
reach an access door, special cut-off or panic buttons shall  be  required.   
When pressed, these buttons, operable by open hand at  appropriate  positions 
about the treatment room, shall cause the irradiation to be terminated.
  (7) Effective means shall be provided to prevent access  to  the  treatment 
room during exposure.  For equipment capable of operating above 150 kVp, each 
access door to  the  treatment  room  shall  be  provided  with  a  fail-safe 
interlock.  The interlock system shall be so designed that the failure of any 
1 component will not jeopardize the safety of the system, (e.g., the  use  of 
series connected double switch assemblies at access doors, and dual interlock 
relays).  If an access door is opened when the machine is "ON", the interlock 
shall cause termination or reduction of exposure as  specified  in  rule  312 
(14).
  (8) Red warning signal lights, energized only when the useful beam in "ON", 
shall be located on the control panel and near each entrance to  the  therapy 
room.  Under conditions as specified in subrule (6) a  visible  signal  shall 
also be located within the therapy room.  Depending upon  control  panel  and 
door locations, a single warning signal light may  be  sufficient  to  comply 
with this subrule.

   History: 1954 ACS 85, Eff. Dec. 3, 1975; 1954 ACS 98, Eff. Mar. 9, 1979.


R 325.5317.  Conditions of operation.
  Rule 317.  (1)  An installation shall be operated in  compliance  with  any 
limitations determined necessary and specified in writing by the department.
  (2) The output of the x-ray generator shall be calibrated  before  use  for 
the treatment of patients for  each  technique  or  condition  of  use.   The 
department shall be informed by telephone or  in  writing  of  completion  of 
initial calibration before patient treatment is initiated.  A written  report 
of this initial calibration only shall be submitted within  30  days  to  the 
department.  Recalibration shall be required after each tube replacement  and 
after any changes or replacement in  the  generating  apparatus  which  could 
effect a change in the x-ray output.  Check calibrations shall be made on  an 
annual basis and records of all calibration maintained for not  less  than  7 
years.
  (3) X-ray therapy equipment capable of operating above 150 kVp shall not be 
operated routinely until the radiation safety of the  installation  has  been 
established by a protection survey conducted in accordance with  rule  221.   
The department shall be informed by telephone or in writing of completion  of 
the initial survey before patient treatment is initiated.  A  written  report 
of this initial survey shall be submitted within 30 days to the department.   
All  x-ray  therapy  equipment  shall  be  operated   in   conformance   with 
recommendations of the protection survey.
  (4) Both the control panel and  the  patient  shall  be  observable  during 
exposure.
  (5) When a  patient  must  be  held  in  position  for  radiation  therapy, 
mechanical supporting or restraining devices should be used.  If the  patient 
must be held by an individual, upon approval by  the  radiologist  in  charge 
followed by written notice  to  the  department,  that  individual  shall  be 
provided protection equivalent  to  7  half-value  layers  and  he  shall  be 
positioned so that no part of his body will be struck by the useful beam  and 
so that his body is as far as possible from the edge of the useful beam.  The 
exposure of any individual used for this purpose shall  be  monitored  and  a 
permanent record maintained.  The individual selected for this purpose  shall 
not otherwise be occupationally exposed to ionizing radiation.
  (6) With the exception of subrule (5), a  person  other  than  the  patient 
shall not be permitted in the treatment room when the  tube  is  operated  at 
potentials exceeding 85 kVp.  At potentials of 85 kVp or below, other persons 
may be permitted in the treatment  room  by  the  radiologist  in  charge  if 
essential to conduct the  treatment,  but  only  if  they  are  protected  as 
specified in subrule (5)  and  their  radiation  exposure  is  monitored  and 
permanently recorded.
  (7) Personnel monitoring shall be performed in controlled  areas  for  each 
individual occupationally exposed  to  ionizing  radiation  from  therapeutic 
x-ray equipment.  Personnel monitoring devices such as film badge  dosimeters 
or  thermoluminescent  dosimeters  shall  be  permanently  assigned  to  each 
occupationally exposed  individual.   This  monitoring  shall  be  continuous 
during employment as a radiation worker.
  (8) Personnel exposure records shall be kept on permanent available file at 
the facility where the exposure occurs.
  (9) Monitoring devices used to estimate whole body exposure shall  normally 
be worn on the chest or abdomen.  Monitoring of any  other  body  part  shall 
comply with rule 222.
  (10) Monitoring devices worn to estimate  personnel  occupational  exposure 
shall not be worn by the individual when he is exposed as a patient  for  any 
medical or dental reason.
  (11)  Lead, lead rubber, lead foil and similar materials used for  limiting 
the field shall not transmit more than  5%  of  the  useful  beam  under  the 
conditions at which the machine is operated for therapy.  This  subrule  does 
not pertain to treatment  blocks  used  to  adjust  or  modify  the  intended 
radiation dose to the area of treatment.
  (12)  A therapeutic x-ray system  shall  not  be  left  unattended  without 
locking the apparatus, room or building in some manner which will prevent use 
of the apparatus by unauthorized persons.

   History: 1954 ACS 85, Eff. Dec. 3, 1975; 1954 ACS 98, Eff. Mar. 9, 1979.


            THERAPEUTIC MACHINES OPERATED AT OR BELOW 85 KVP


R 325.5321. X-ray equipment.
  Rule  321.   (1)   The  x-ray  equipment  shall  comply  with  the  general 
requirements of rule 312 excluding subrules (11), (14) and (16).
  (2) Maximum potential shall be mechanically or electronically limited to 85 
kVp.
  (3) A contact therapy machine shall meet the  additional  requirement  that 
the leakage radiation at 5 centimeters (2 inches) from  the  surface  of  the 
tube housing shall not exceed 0.1 R/h.  As  used  in  this  subrule  "contact 
therapy machine" means an x-ray therapy machine designed for source  to  skin 
treatment distances of 5 centimeters or less at tube potentials in the  range 
of 20 to 50 kVp.

   History: 1954 ACS 85, Eff. Dec. 3, 1975; 1954 ACS 98, Eff. Mar. 9, 1979.


R 325.5322.  Enclosures.
  Rule 322.  An enclosure shall comply with the general requirements of rules 
315 (1) and (2).

   History: 1954 ACS 85, Eff. Dec. 3, 1975; 1954 ACS 98, Eff. Mar. 9, 1979.


R 325.5323.  Conditions of operation.
  Rule 323.  (1)  Operation shall comply with  the  general  requirements  of 
rule 317.
  (2) If the x-ray tube of a contact therapy machine as defined in  rule  321 
(3) is hand held during  irradiation,  the  operator  shall  wear  protective 
gloves and a protective apron.   When  practical,  a  cap  of  at  least  0.5 
millimeter lead equivalence should cover the  aperture  window  of  the  tube 
housing of such apparatus when the apparatus is not being used.  Because  the 
exposure rate at the surface of the window of contact therapy  and  beryllium 
window machines may be more than 10,000 R per minute, extreme precautions are 
necessary to prevent accidental exposure to the useful beam.

   History: 1954 ACS 85, Eff. Dec. 3, 1975; 1954 ACS 98, Eff. Mar. 9, 1979.


                        FIXED RADIOGRAPHIC INSTALLATIONS


R 325.5325.  X-ray equipment.
  Rule 325.  (1) All x-ray tube housings in fixed radiographic  installations 
shall be of the diagnostic type.
  (2) The aluminum equivalent of the total  filtration  in  the  useful  beam 
shall not be less than the values shown in Table 1.

                                TABLE 1

Operating kVp                                           Minimum Total  Filter 
(Inherent plus added)

Below 50 kVp                                            0.5 mm aluminum 50-70 
kVp                                               1.5 mm  aluminum  Above  70 
kVp                                            2.5 mm aluminum


  (3) If the filter in the machine is not accessible for examination and  the 
total filtration is not known subrule (2) may be assumed to have been met  if 
the half-value layer is not less than
        0.6 mm aluminum at 49 kVp
        1.6 mm aluminum at 70 kVp
        2.6 mm aluminum at 90 kVp
  (4) Under conditions of subrule  (3)  for  tube  potentials  above  90  kVp 
subrule (2) may be assumed to have been met if the half-value  layer  is  not 
less than that specified in table 2.
  (5) The half-value layer (HVL) of the useful beam for a  given  x-ray  tube 
potential shall not be less than the values shown in table 2.

                                TABLE 2

        Design operating range  Measured potential      Half-value layer
        (Kilovolts peak)        (Kilovolts peak)        (Millimeters)

        Below 50                        30                      0.3
                                        40                      0.4
                                        49                      0.5
        50 to 70                        50                      1.2
                                        60                      1.3
                                        70                      1.5
        Above 70                        80                      2.3
                                        90                      2.5
                                        100                     2.7
                                        110                     3.0
                                        120                     3.2
                                        130                     3.5
                                        140                     3.8
                                        150                     4.1

  (6) If it is necessary to determine the half-value layer at an  x-ray  tube 
potential  which  is  not  listed  in  table  2,  linear   interpolation   or 
extrapolation may be made.  Positive means shall be provided to  insure  that 
at least  the  minimum  filtration  needed  to  achieve  these  beam  quality 
requirements is in the useful beam during each exposure.
  (7) Machines equipped with beryllium  window  x-ray  tubes  with  removable 
filters shall contain keyed filter interlock switches in the tube housing and 
suitable indication on the control panel of the added filter  in  the  useful 
beam.  The total filtration permanently in the useful beam shall not be  less 
than 0.5 millimeter aluminum equivalent and shall be clearly indicated on the 
tube housing.
  (8) Beryllium window x-ray tubes shall not be used  routinely  for  general 
purpose diagnostic examinations.  Such a tube may comprise an x-ray subsystem 
if needed for special soft tissue technique in accord with subrule (7).
  (9) Beam-limiting  devices  (diaphragms,  cones,  adjustable  collimators), 
capable of restricting the useful beam to the area radiographically  recorded 
shall be provided to define the beam and shall provide  the  same  degree  of 
attenuation as that required of the tube housing.
  (10)  Beam-limiting devices shall be calibrated in terms of the size of the 
projected useful  beam  at  specified  source-image  distances  (SID).   This 
calibration shall be clearly and permanently recorded  on  the  beam-limiting 
device.   Calibration  of  adjustable  beam-limiting  devices  shall   permit 
reproducible settings.
  (11)  X-ray systems designed for only 1 image receptor size at a fixed  SID 
shall be provided with means to limit the field at the  plane  of  the  image 
receptor to dimensions no greater than those of the image  receptor,  and  to 
align the center of the x-ray field with the center of the image receptor  to 
within 2% of the SID.  However, for mammography the x-ray field need  not  be 
aligned with the center of the image receptor if the  x-ray  field  does  not 
extend beyond the edge of the image receptor.
  (12)  General purpose radiographic x-ray systems  shall  be  equipped  with 
adjustable beam-limiting devices containing light localizers that define  the 
entire field.  Rectangular beam-limiting devices are usually preferable.
  (13)  The size of the x-ray beam projected by fixed aperture beam- limiting 
devices, except those  used  for  stereoradiography,  shall  not  exceed  the 
dimensions of the image receptor by more than 2% of the SID when the axis  of 
the x-ray beam is perpendicular to the plane of the image receptor.
  (14)  The calibrated  field  size  indicator  on  adjustable  beam-limiting 
devices shall be accurate to within 2% of the SID.  The light field shall  be 
aligned with the x-ray field with the same degree  of  accuracy.   The  field 
size projected by automatic adjustable beam-limiting  devices  shall  provide 
the same precision.
  (15)  For radiographic procedures resulting in multiple views on  a  single 
x-ray film the beam-limiting device shall limit the x-ray field size  to  the 
recorded radiographic image size within 2% of the SID.  Covering a portion of 
the radiographic film with radio-opaque material  is  not  a  substitute  for 
proper x-ray field limitation.  This  subrule  does  not  apply  to  spotfilm 
devices manufactured before the effective date of these rules.
  (16)  After the effective date of these rules radiographic  x-ray  machines 
used for purposes other than mammography or extremity radiography only  shall 
be capable  of  operation  at  not  less  than  an  average  current  of  100 
milliamperes (mA) during any radiographic  technique  used.   A  machine  not 
capable of sustained operation at not less than an average of 100 mA for  the 
duration of a given technique shall not be used for that technique.
As used in this subrule "extremity radiography" means radiography of the hand 
or arm excluding the shaft of the humerus or the foot or  leg  excluding  the 
shaft of the femur.
  (17)  A device shall be provided which terminates the exposure at a  preset 
time interval or exposure limit.  The operator shall be able to terminate the 
exposure at any time by  discontinuing  pressure  upon  the  exposure  switch 
except that during  serial  radiography  means  may  be  provided  to  permit 
completion of any single exposure in progress.
  (18)  The exposure switch, except for those used in conjunction  with  spot 
film devices in fluoroscopy, shall be securely fixed so that the operator  is 
required to be behind a fixed shield which will intercept the useful beam and 
any radiation which has been scattered only once.
  (19)  When 2 or more x-ray tube heads are operated from a  single  exposure 
switch (multiple tube units), there shall be indication at the control  panel 
showing which tube is connected and ready  to  be  energized,  and  means  to 
prevent energizing more than 1 tube head at the same time  unintentionally.   
Machines  designed  for  simultaneous  multiple  tube  operation  shall  have 
positive means for selecting single tube or multiple tube operation.
  (20)  The control panel shall provide positive visual identification of the 
production of x-rays whenever the x-ray tube is  energized.   A  milliammeter 
may comply with this subrule.
  (21)  On radiographic machines manufactured after  the  effective  date  of 
these rules, a signal  audible  to  the  operator  shall  indicate  that  the 
exposure has ended.
  (22)  The technique  factors  to  be  used  during  an  exposure  shall  be 
indicated before the exposure begins, except when automatic exposure controls 
are used, in which case the  technique  factors  which  are  set  before  the 
exposure shall be indicated.  On equipment having  fixed  technique  factors, 
this requirement may be met by permanent markings.
Indication of technique factors shall be visible from the operator's position.
  (23)  X-ray equipment installed after the effective  date  of  these  rules 
shall be installed and used in accord with the appropriate  portions  of  the 
1975 national electrical code (NFPA No. 70-1975) reproduced or referenced  in 
rule 359.  X-ray equipment installed before the effective date of these rules 
shall conform with the appropriate national electrical code in effect at  the 
time of installation.

   History: 1954 ACS 85, Eff. Dec. 3, 1975; 1954 ACS 98, Eff. Mar. 9, 1979.


R 325.5331.  Enclosures.
  Rule 331.  (1)  An enclosure shall be a permanent part of the  building  or 
equipment.  Portable shields shall not be used for permanent installations.
  (2) The degree of protection required for an enclosure shall be  determined 
by  the  workload,  use  and   occupancy   factors   and   the   kilovoltage, 
milliamperage, mechanical movement and distance factor, and shall be  subject 
to design approval by the department.  Recommended shielding appears in  rule 
357.
  (3) Radiographic-room wall and floor areas exposed to the useful beam  plus 
an additional area extending at least 30 centimeters (1 foot) beyond shall be 
provided with a primary protective barrier where necessary as  determined  by 
workload,  use,  occupancy  and  distance  factors.   All  vertical   primary 
protective barriers specified in this rule shall extend continuously from the 
floor to a minimum height of 2.1 meters (7 feet).
  (4) Secondary protective barriers shall be  provided  in  the  radiographic 
room ceiling and in those walls not requiring primary barriers.
  (5) Control apparatus for the radiographic equipment shall be shielded by a 
primary protective barrier which cannot be removed from a protective position 
between the operator and the radiation source during machine operation.
  (6) Movable barriers with electrical interlocks shall not  be  approved  in 
lieu of compliance with subrule (5).
  (7) Exposure switch location and control shield shall be oriented so  that, 
at arm's length from the exposure switch, the operator shall not  be  exposed 
to the useful beam, leakage radiation or any radiation scattered only once.
 (8) The operator shall be able to see and communicate with the patient  from 
a shielded position at the control panel.   When  an  observation  window  is 
provided, it shall be a lead equivalence at least equal to that  required  of 
the  control  barrier  and  shall  be  installed  so  that  the   attenuation 
effectiveness of the barrier is not impaired.
  (9) At times it may be necessary for personnel to remain  within  operating 
room or special procedure installations  during  radiographic  exposures.   A 
primary protective barrier shall be provided for personnel  protection  under 
these  circumstances  unless  necessary  technique  prevents  use   of   such 
protection.  This barrier may be  movable  if  necessary.   Movable  barriers 
shall not be permitted in lieu of the provisions of subrules (3) and (5).

   History: 1954 ACS 85, Eff. Dec. 3, 1975; 1954 ACS 98, Eff. Mar. 9, 1979.


R 325.5333.  Conditions of operation.
  Rule 333.  (1) An operator shall properly utilize the beam-limiting devices 
provided to restrict the useful beam to the  smallest  area  consistent  with 
clinical requirements.  Particular care shall be taken  to  align  accurately 
the x-ray beam with the patient and film.
  (2) The operator shall insure the presence of  adequate  filtration  before 
any radiographic procedure.
  (3) Staff personnel routinely working  with  or  around  radiation  sources 
shall not be required by the licensee or registrant to hold film or  restrain 
patients during  radiography.   If  such  procedure  is  permitted  personnel 
exposure shall not exceed rule 205 or the procedure shall be prohibited.
  (4) When a patient must be held in  position  for  radiography,  mechanical 
supporting or restraining devices shall be available and shall be used unless 
contraindicated.  If  the  patient  must  be  held  by  an  individual,  this 
individual shall wear  protective  gloves  and  a  protective  apron  of  0.5 
millimeter minimum lead equivalence and he shall be  so  positioned  that  no 
part of his body will be struck by the useful beam and that his  body  is  as 
far as possible from the edge of the useful beam.
  (5) Only individuals whose presence is necessary shall be permitted in  the 
radiographic room during exposure.   Each  individual,  except  the  patient, 
shall be protected by 0.5 millimeter minimum lead  equivalent  aprons  unless 
protected by an approved primary barrier.
  (6) Personnel monitoring shall be performed in controlled  areas  for  each 
individual occupationally exposed to ionizing radiation  from  diagnostic  x- 
ray equipment.  Personnel monitoring devices such as film badge dosimeters or 
thermoluminescent  dosimeters  shall  be   permanently   assigned   to   each 
occupationally exposed  individual.   This  monitoring  shall  be  continuous 
during employment as a radiation worker.
  (7) Personnel exposure records shall be kept on permanent available file at 
the facility where the exposure occurs.
  (8) Monitoring devices used to estimate whole body exposure shall  normally 
be worn on the chest or abdomen.  Monitoring of any  other  body  part  shall 
comply with rule 222.
  (9) Monitoring devices worn to  estimate  personnel  occupational  exposure 
shall not be worn by the individual when he is exposed as a patient  for  any 
medical or dental reason.
  (10)   The  gonads  of  children  and  persons  who  have  not  passed  the 
reproductive age shall be protected from the useful beam either by the use of 
shielding (0.5 mm lead equivalent), collimation,  or  special  gonad  shields 
when this will not  interfere  with  the  conditions  or  objectives  of  the 
examination.
  (11)  Intensifying screens shall be employed  to  reduce  patient  exposure 
except in cases where a noticeable decrease in image  definition  may  reduce 
the clinical value of the examination.  Film and  screen  speed  combinations 
shall be carefully selected to produce  the  necessary  clinical  information 
with the least exposure to  the  patient  consistent  with  current  clinical 
judgement.
  (12)  Film processing materials and techniques shall be  those  recommended 
by the x-ray film and processing  materials  manufacturers  unless  otherwise 
tested to insure maximum information content of the  developed  film.   Sight 
developing in not permitted except under extreme emergency conditions.
Correct temperature control and development time are  necessary  to  minimize 
radiation dose to the patient.
  (13)  A radiographic x-ray system shall  not  be  left  unattended  without 
locking the apparatus, room or building in some manner which will prevent use 
of the apparatus by unauthorized persons.

   History: 1954 ACS 85, Eff. Dec. 3, 1975; 1954 ACS 98, Eff. Mar. 9, 1979.


                        FIXED FLUOROSCOPIC INSTALLATIONS


R 325.5337.  X-ray equipment.

  Rule 337.  (1) All x-ray tube housings of fixed fluoroscopic  installations 
shall be of the diagnostic type.
  (2) The aluminum equivalence of the total  filtration  permanently  in  the 
useful beam shall not be less than 2.5 millimeters aluminum.
  (3) Beam quality of fluoroscopic machines manufactured after the  effective 
date of these rules shall comply with the provisions of rules 325 (5) and (6).
  (4) The  source-patient  distance  on  fluoroscopic  machines  manufactured 
before the effective  date  of  these  rules  should  not  be  less  than  45 
centimeters (18 inches) and  shall  not  be  less  than  30  centimeters  (12 
inches).  Specific exemption may be granted in writing by the department  for 
special purpose equipment such as heart catheterization machines.
  (5) On fluoroscopic machines manufactured after the effective date of these 
rules, means shall be provided to limit the source-skin distance to not  less 
than  38  centimeters.   For  image  intensified  fluoroscopes  intended  for 
specific surgical application that would be prohibited at this  source-  skin 
distance, provisions  may  be  made  for  operation  at  shorter  source-skin 
distances but in no case less than 20 centimeters.
  (6) Provision shall be made to intercept  the  scattered  x-rays  from  the 
undersurface of the table top and other  structures  under  the  fluoroscopic 
table if the tube is mounted under the table.  A cone or shield shall provide 
the same degree of attenuation as is required of the tube housing.
  (7) On fluoroscopic machines manufactured after the effective date of these 
rules a shielding device of at least 0.25  millimeter  lead  equivalence  for 
covering the bucky slot during fluoroscopy shall be provided.
  (8) On fluoroscopic machines manufactured after the effective date of these 
rules a shielding device of at least 0.25 millimeter lead  equivalence,  such 
as overlapping protective drapes or hinged or sliding panels, shall  be  used 
to  intercept  scattered  radiation   which   would   otherwise   reach   the 
fluoroscopist and others near the machine.
  (9) The equipment shall be so constructed that, under conditions of  normal 
use, the entire cross-section of the useful beam is attenuated by  a  primary 
protective barrier, permanently incorporated into the equipment.
The exposure shall automatically terminate when the barrier is  removed  from 
the useful beam.
  (10) On fluoroscopic machines manufactured  after  the  effective  date  of 
these rules:
  (a) The entire cross section of the useful beam shall be intercepted by the 
primary protective barrier of the fluoroscopic image assembly at  any  SID.   
The fluoroscopic tube shall not produce  x-rays  unless  the  barrier  is  in 
position to intercept the entire useful  beam.   The  exposure  rate  due  to 
transmission through the barrier with the attenuation  block  in  the  useful 
beam combined with radiation from the image intensifier, if  provided,  shall 
not exceed 2 milliroentgens per hour at 10 centimeters  from  any  accessible 
surface of the fluoroscopic imaging assembly beyond the plane  of  the  image 
receptor for each roentgen per minute of entrance exposure rate.
  (b) The entrance exposure rate shall be measured in accordance with subrule 
(20).  The exposure rate due to  transmission  through  the  primary  barrier 
combined with radiation from the image intensifier  shall  be  determined  by 
measurements averaged over an area of 100 square centimeters with  no  linear 
dimension greater than 20 centimeters.  If the source is below the  tabletop, 
the measurement shall be made with the  input  surface  of  the  fluoroscopic 
imaging assembly positioned 30 centimeters above the tabletop.  If the source 
is above the tabletop and the SID is variable, the measurement shall be  made 
with the end of the beam-limiting device or spacer as close to  the  tabletop 
as it can be placed, if it is not closer than 30 centimeters.  Movable  grids 
and compression devices shall be removed from  the  useful  beam  during  the 
measurement.  For all measurements, the attenuation block shall be positioned 
in the useful beam 10 centimeters  from  the  point  of  measurement  of  the 
entrance exposure rate and between this point and the input  surface  of  the 
fluoroscopic imaging assembly.
  (11) The lead equivalence of the barrier of conventional fluoroscopes shall 
be not less than 1.5 millimeters at 100 kVp, 1.8 millimeters at 125 kVp,  and 
2.0 millimeters at potentials greater than 125 kVp.
  (12) A beam-limiting device shall be provided to restrict the size  of  the 
useful beam to less than the  area  of  the  barrier.   The  x-ray  tube  and 
beam-limiting system shall be linked with the fluorescent screen assembly  so 
that the useful beam at the fluorescent screen is confined within the barrier 
irrespective of the  panel-screen  distance.   For  image  intensifiers,  the 
useful beam shall be centered on the input phosphor.  It  should  not  exceed 
the diameter of the input phosphor during fluoroscopy or  cine-  recording.   
Ideally, for spot film radiography  with  image  intensifier  equipment,  the 
shutters should automatically open to the required  field  size  before  such 
exposure.
  (13) Beam-limiting devices (collimators, adjustable diaphragms or shutters) 
shall provide the same degree of attenuation  as  is  required  of  the  tube 
housing.
  (14) When the beam-limiting device is  opened  to  its  fullest  extent,  a 
minimum ¼  inch  unilluminated  margin  shall  exist  at  all  edges  of  the 
fluorescent screen when the screen is 35 centimeters  (14  inches)  from  the 
panel surface or table top, or at the fixed screen position in equipment such 
as  an  orthodiascope.   In  equipment  used  solely  for  image  intensified 
fluoroscopy, the x-ray beam  shall  not  have  dimensions  greater  than  the 
diameter of the input phosphor.
  (15) On fluoroscopic machines manufactured  after  the  effective  date  of 
these rules:
  (a) The x-ray field produced by nonimage-intensified fluoroscopic equipment 
shall not extend beyond the entire visible area of the image receptor.  Means 
shall be provided to permit further limitation of  the  field.   The  minimum 
field size at the greatest SID shall  be  equal  to  or  less  than  5  by  5 
centimeters.
  (b) For image-intensified fluoroscopic equipment the total misalignment  of 
the edges of the x-ray field with the respective edges of the visible area of 
the image receptor along any dimension of the visually defined field  in  the 
plane of the image receptor shall not exceed 3% of the SID.
The sum, without regard to sign, of the misalignment along any  2  orthogonal 
dimensions intersecting at the center  of  the  visible  area  of  the  image 
receptor shall not exceed 4% of the SID.  For rectangular x-ray  fields  used 
with circular image receptors, the error in  alignment  shall  be  determined 
along the length and width dimensions of the x-ray field which  pass  through 
the center of the visible  area  of  the  image  receptor.   Means  shall  be 
provided to permit further limitation of the field.  The minimum field  size, 
at the greatest SID, shall be equal to or less than 5 by 5 centimeters.
  (16)  X-ray production in the fluoroscopic mode shall be  controlled  by  a 
device which requires continuous pressure by the operator for the entire time 
of any exposure. When recording  serial  fluoroscopic  images,  the  operator 
shall be able to terminate the x-ray exposures at any time, but means may  be 
provided to permit completion  of  any  single  exposure  of  the  series  in 
progress.
  (17) When the fluoroscope is operated at 80 kVp, the exposure rate  at  the 
position where the beam enters the patient shall not exceed 3.2 R/mA-min  and 
should not exceed 2.1 R/mA-min.
  (18) The entrance exposure rate at the position where  the  center  of  the 
useful beam enters the patient should be as low as  is  consistent  with  the 
fluoroscopic requirements and shall  not  normally  exceed  10  R/min.   With 
modern equipment, most fluoroscopy can be carried out with entrance  exposure 
rates of less than 5 R/min.
  (19) Entrance exposure rate limits for fluoroscopic equipment  manufactured 
after the effective date of these rules shall be as follows:
  (a) Machines with automatic exposure rate control shall not be operable  at 
any combination of tube potential and current  which  will  result  in  an  a 
exposure rate in excess of 10 roentgens per minute at  the  point  where  the 
center of the useful beam enters the  patient,  except  during  recording  of 
fluoroscopic images or when an optional high level control is provided.
When so provided, the equipment shall not be operable at any  combination  of 
tube potential and current which will result in an exposure rate in excess of 
5 roentgens per minute at the point where  the  center  of  the  useful  beam 
enters the patient unless the high level control is activated.
Special means of activation  of  high  level  controls,  such  as  additional 
pressure applied continuously by the operator, shall  be  required  to  avoid 
accidental use.  A continuous  signal  audible  to  the  fluoroscopist  shall 
indicate that the high level control is being employed.
  (b) Machines without automatic exposure rate control shall not be  operable 
at any combination of tube potential and current  which  will  result  in  an 
exposure rate in excess of 5 roentgens per minute  at  the  point  where  the 
center of the useful beam enters the  patient,  except  during  recording  of 
fluoroscopic images or when a optional high level control is activated.
Special means of activation  of  high  level  controls,  such  as  additional 
pressure applied continuously by the operator, shall  be  provided  to  avoid 
accidental use.  A continuous  signal  audible  to  the  fluoroscopist  shall 
indicate that the high level control is being employed.
  (20) Compliance with subrules (18) and (19) shall be determined as follows:
  (a) If the source is below the table, the exposure rate shall be measured 1 
centimeter above the tabletop or cradle.
  (b) If the source is above the table, the exposure rate shall  be  measured 
at 30 centimeters above the tabletop with the end of the beam-limiting device 
or spacer positioned as closely as possible to the point of measurement.
  (c) In a C-arm type of fluoroscope, the exposure rate shall be measured  30 
centimeters from the input surface of the fluoroscopic imaging assembly.
  (21) A cumulative timing device,  activated  by  the  fluoroscope  exposure 
switch, shall be provided.  It shall indicate the passage of a  predetermined 
period  if  irradiation  either  by  an  audible  signal  or   by   temporary 
interruption of the irradiation when the increment of exposure time exceeds a 
predetermined limit not exceeding 5 minutes.
  (22) On fluoroscopic machines manufactured  after  the  effective  date  of 
these rules means shall be provided to present the cumulative on-time of  the 
fluoroscopic tube. The maximum cumulative time of the timing device shall not 
exceed 5 minutes without resetting.  A signal audible  to  the  fluoroscopist 
shall indicate the completion of any preset cumulative on- time.  This signal 
shall continue to sound while x-rays are produced until the timing device  is 
reset.
  (23) Devices which indicate the x-ray tube potential and current  shall  be 
provided.  On image intensified fluoroscopic equipment, these devices  should 
be located in such a manner that the operator may monitor the tube  potential 
and current during fluoroscopy.
  (24)  X-ray equipment shall be installed and used in  accord  with  article 
660 of the national electrical code which is reproduced in rule 359.

   History: 1954 ACS 85, Eff. Dec. 3, 1975; 1954 ACS 98, Eff. Mar. 9, 1979.


R 325.5347.  Enclosures.
  Rule 347.  (1)  An enclosure shall be a permanent part of the  building  or 
equipment.  Portable shields shall not be used for permanent installations.
  (2) The degree of protection required for an enclosure shall be  determined 
by  the  workload,  use  and   occupancy   factors   and   the   kilovoltage, 
milliamperage, mechanical movement and distance factor, and shall be  subject 
to design approval by the department.  Recommended shielding appears in  rule 
357.
  (3) For conventional fluoroscopy extraneous light that interferes with  the 
fluoroscopic examination shall be eliminated.  Dark  adaptation  normally  is 
not necessary when using image intensifiers.

   History: 1954 ACS 85, Eff. Dec. 3, 1975; 1954 ACS 98, Eff. Mar. 9, 1979.


R 325.5348.  Conditions of operation.
  Rule 348.  (1)  Each individual present in a fluoroscopic room, except  the 
patient, shall wear a protective  apron  of  at  least  0.5  millimeter  lead 
equivalence.
  (2) Only individuals whose presence is needed to conduct  the  examination, 
to conduct radiation protection surveys or undergoing specific training shall 
be permitted in the fluoroscopy room during x-ray exposures.
  (3) Personnel monitoring shall be performed in controlled  areas  for  each 
individual occupationally exposed to ionizing radiation  from  diagnostic  x- 
ray equipment.  Personnel monitoring devices, such as film  badge  dosimeters 
or thermoluminescent  dosimeters,  shall  be  permanently  assigned  to  each 
occupationally exposed  individual.   This  monitoring  shall  be  continuous 
during employment as a radiation worker.
  (4) Personnel exposure records shall be kept on permanent available file at 
the facility where the exposure occurs.
  (5) Monitoring devices used to estimate whole body exposure shall  normally 
be worn on the chest or abdomen.  Monitoring or any  other  body  part  shall 
comply with rule 222. Since employees involved in fluoroscopic procedures are 
required to wear protective  aprons  and  may  be  subjected  to  non-uniform 
radiation fields, a dosimeter assigned to monitor whole  body  exposure  will 
not necessarily record the dose most representative of exposure to  the  lens 
of the eye.  To monitor this critical area for which the  exposure  limit  is 
the same as for whole  body,  active  blood-forming  organs,  or  gonads,  an 
auxiliary dosimeter shall be provided in accordance with rule 222.
  (6) Monitoring devices worn to  estimate  personnel  occupational  exposure 
shall not be worn by the individual when he is exposed as a patient  for  any 
medical or dental reason.
  (7) The fluoroscopist's eyes should be sufficiently  dark-adapted  for  the 
visual task required before commencing conventional  fluoroscopy.   Under  no 
circumstances shall he attempt to compensate  for  inadequate  adaptation  by 
increasing exposure  factors  employed  or  by  prolonging  the  fluoroscopic 
examination.
  (8) Special precautions, consistent with clinical needs, shall be taken  to 
minimize exposure of the  gonads  of  potentially  procreative  patients  and 
exposure of the embryo or fetus in patients known to be or suspected of being 
pregnant.  Gonadal shielding is advised whenever it will not  interfere  with 
the conditions or objectives of the examination.
  (9) In cineradiography, special  care  shall  be  taken  to  limit  patient 
exposure when, as is often the case, tube currents  and  potentials  employed 
are higher than those normally used in fluoroscopy.  The  exposure  rates  to 
which patients are normally  subjected  shall  be  determined  quarterly  and 
records of the surveys maintained.
  (10)  A fluoroscopic x-ray system shall  not  be  left  unattended  without 
locking the apparatus, room or building in some manner which will prevent use 
of the apparatus by unauthorized persons.

   History: 1954 ACS 85, Eff. Dec. 3, 1975; 1954 ACS 98, Eff. Mar. 9, 1979.


                MOBILE OR PORTABLE DIAGNOSTIC X-RAY EQUIPMENT


R 325.5351.  X-ray equipment.
  Rule 351.  (1)  Radiographic x-ray equipment shall comply with the  general 
requirements of rule 325 excluding subrules (11) and (18).
  (2) Fluoroscopic x-ray equipment shall comply with the general requirements 
of rule 337 excluding subrules (5), (6), (7), (8) and (11).
  (3) The radiographic exposure  control  switch  shall  be  located  on  the 
machine where adequate personnel protection  is  provided  to  attenuate  the 
direct and scatter radiation, or the length of switch cord shall be such that 
the operator shall be able to stand at least 1.8 meters  (6  feet)  from  the 
patient, the x-ray tube, and out of  useful  beam.   A  coil  type  extension 
switch cord capable of providing more than 1.8 meters (6  feet)  of  distance 
protection is recommended.
  (4) Hand-held fluoroscopic screens and others not attached to a  diagnostic 
source assembly with stable mounting shall not be used.
  (5) Image intensification shall always be provided on  mobile  fluoroscopic 
equipment.  It shall be impossible to operate mobile  fluoroscopic  equipment 
unless the useful beam is intercepted by the image intensifier.  Means  shall 
be provided to limit the source-skin distance to not less than 30 centimeters 
(12 inches).  For fluoroscopes intended  for  specific  surgical  application 
that would be prohibited at  the  source-skin  distances  specified  in  this 
subrule, provisions may  be  made  for  operation  at  shorter  source-  skin 
distances but in no case less than 20 centimeters.

   History: 1954 ACS 85, Eff. Dec. 3, 1975; 1954 ACS 98, Eff. Mar. 9, 1979.


R 325.5352.  Shielding.
  Rule 352.  (1)  Portable shielding shall be used by the operator and others 
in the room when possible, 1.6 millimeter (1/16 inch) lead equivalent.
  (2) Mobile or portable diagnostic  x-ray  equipment  used  routinely  in  1 
location shall be considered a fixed installation and shall comply  with  the 
general requirements of rules 325 and 331 or rules 337 and 347 or both.

   History: 1954 ACS 85, Eff. Dec. 3, 1975; 1954 ACS 98, Eff. Mar. 9, 1979.


R 325.5353.  Conditions of operation.
  Rule 353.  (1)  Operation shall comply with  the  general  requirements  of 
rules 333 and 348.
  (2) Individuals operating mobile or  portable  diagnostic  x-ray  equipment 
shall wear a protective apron of  minimum  0.5  millimeter  lead  equivalence 
unless portable shielding is provided as specified in rule 352 (1).
  (3) Mobile or portable diagnostic x-ray equipment shall  not  be  used  for 
routine radiography  or  fluoroscopy  in  hospitals  or  private  offices  of 
practitioners of the healing arts.  This equipment shall only be used when it 
is medically inadvisable to move a patient to a fixed radiographic  or  fixed 
fluoroscopic installation.

   History: 1954 ACS 85, Eff. Dec. 3, 1975; 1954 ACS 98, Eff. Mar. 9, 1979.


                        MISCELLANEOUS AND SPECIAL INSTALLATIONS


R 325.5355.  General provisions.
  Rule 355.  (1) Types of x-ray sources and uses not specifically covered  by 
this part and not exempted in rule 182, shall comply with parts 1, 4 and 5.
  (2) For the purpose of registering and approving  medical  x-ray  producing 
equipment and devices not specifically covered by  this  part  (e.g.  therapy 
simulators) the protective design, the  workload,  the  use  factor  and  the 
occupancy factor shall be considered.
  (3)  Therapy  simulators   are   considered   special   installations   not 
specifically  covered  by  this  part  and  shall  be  subject  to   specific 
requirements designated  by  the  department  in  the  form  of  registration 
conditions for the protection of public health and safety until  these  rules 
are amended to specifically cover such sources and uses.

   History: 1954 ACS 85, Eff. Dec. 3, 1975; 1954 ACS 98, Eff. Mar. 9, 1979.


R 325.5357.  Appendix A. Table 1.
  Rule 357. Recommended shielding for medical diagnostic x-ray installations.*

                        High Workload           Moderate  Workload        Low 
Workload
                        Hospitals   Radiology       Clinics                   
Offices

Anticipated workload    250-1000 mA-min/wk      15-250 mA-min/wk         0-15 
mA-min/wk

Thickness of shielding  Lead t     Concrete tt  Lead t    Concrete tt    Lead 
t   Concrete tt
  material or  equiv-     (inches)    (inches)      (inches)   (inches)       
(inches) (inches)
  alent protection

OPERATOR SHIELDS        1/16-1/8   5-9          1/16       5            1/16  
    5

PRIMARY BEAMS
  Walls                 1/16-1/8   5-9          1/16       5            1/16  
    5
  Doors                 1/16-1/8    -           1/16       -            1/16  
    -
  Floors                3/32-1/8   6*-9         1/16-3/32  5-6*         1/16  
    5

SECONDARY RADIATION
  Walls                  1/16        5             1/32-1/16   2*-5           
0-1/32    0-2*
  Doors                  1/16        -             1/32-1/16    -             
0-1/32     -
  Floors                 1/16        5             1/32-1/16   2*-5           
0-1/32    0-2*
  Ceilings               1/16        2.5           1/32        2*             
0-1/32    0-2*

* This table is provided only as a guideline for optimum shielding protection 
for a few  typical  radiographic  workloads  and  conditions  encountered  in 
hospital, clinic in the office situations.  More or  less  shielding  may  be 
required in  any  specific  case  depending  upon  many  variable  factors.   
Shielding listed is that generally approved by the division  of  radiological 
health. t Thickness ranging from 1/32 - 1/8 inch  based  on  commercial  lead 
sheets ranging from 2-8 pounds per square foot nominal weight.  tt  Thickness 
based on concrete density of 2.35 grams  per  cubic  centimeter  (147  pounds 
percubic foot).

  Note: As a result of Executive Orders 1996-1 and  1996-2,   the  authority, 
powers, duties, functions, and  responsibilities  of  the  radiation  machine 
registration, licensing, and  compliance  program  were  transferred  to  the 
Michigan Department of Consumer & Industry Services.  The reference in  these 
rules to the  Division  of  Radiological  Health  should  now  reference  the 
Radiation Safety Section.

   History: 1954 ACS 85, Eff. Dec. 3, 1975; 1954 ACS 98, Eff. Mar. 9, 1979.


R 325.5358.  Appendix A. Table 2.
  Rule 358.  Distances at which shielding may not  be  required  for  medical 
radiographic installations.
                                Table 2

                        High Workload           Moderate  Workload        Low 
Workload
                        Hospitals   Radiology       Clinics                   
Offices
                        Offices

Anticipated workload    250-1000 mA-min/wk      15-250 mA-min/wk         0-15 
mA-min/wk

        DISTANCE IN FEET FROM X-RAY TUBE TO NEAREST OCCUPIED AREA

PRIMARY BEAMS
  Area controlled       25-200                  10-50                   6-25
  Area non-controlled   80-300                  25-150                  15-50

SECONDARY RADIATION
  Area controlled       10-25                   3-15                    0-10
  Area non-controlled   30-80                   10-40                   5-15

* This table is provided only as  a  guideline  to  emphasize  the  need  for 
protective shielding under most circumstances in typical installations.
Distances may vary considerably depending upon many uncontrollable factors.
Shielding is the preferred method of radiation protection because it  can  be 
precisely calculated and controlled.

   History: 1954 ACS 85, Eff. Dec. 3, 1975; 1954 ACS 98, Eff. Mar. 9, 1979.


R 325.5359.  Appendix B.        National Electrical Code
  Rule 359.   Excerpts from Articles 100, 500, 517 and 660.

                        ARTICLE 100 - DEFINITIONS

Approved: Acceptable to the authority having jurisdiction.

Approved for the Purpose: Approved for a specific  purpose,  environment,  or 
application described in a particular Code requirement.

Ground: A conducting connection, whether intentional or  accidental,  between 
an electrical circuit or equipment and the earth, or to some conducting  body 
that serves in place of the earth.

Grounded: Connected to earth or to some conducting body that serves in  place 
of the earth.

Grounded Conductor:  A system or  circuit  conductor  that  is  intentionally 
grounded.

Grounding Conductor:  A conductor used to connect equipment or  the  grounded 
circuit of a wiring system to a grounding electrode or electrodes.

Grounding Conductor Equipment:  The conductor  used  to  connect  noncurrent- 
carrying metal parts of equipment, raceways,  and  other  enclosures  to  the 
system grounded conductor at  the  service  and/or  the  grounding  electrode 
conductor.

                                ARTICLE 500
                        HAZARDOUS (CLASSIFIED) LOCATIONS

  500-4. Class I Locations. Class I locations are those  in  which  flammable 
gases or vapors are or may be present in the air in quantities sufficient  to 
produce explosive or ignitible mixtures.  Class  I  locations  shall  include 
those specified in (a) and (b) below.
  (a) Class I, Division 1.  A Class I, Division 1 location is a location:
(1) in which hazardous concentrations of  flammable  gases  or  vapors  exist 
continuously,  intermittently,  or  periodically   under   normal   operating 
conditions; or (2) in which hazardous concentrations of such gases or  vapors 
may exist frequently because of repair or maintenance operations  or  because 
of leakage; or (3) in which breakdown or faulty  operation  of  equipment  or 
processes that might release hazardous concentrations of flammable  gases  or 
vapors, and might also cause simultaneous failure of electric equipment.

                        ARTICLE 517 - HEALTH CARE FACILITIES

  517-2. Definitions.

Anesthetizing Location. Any area in which it is intended  to  administer  any 
flammable or nonflammable inhalation  anesthetic  agents  in  the  course  of 
examination or  treatment  and  includes  operating  rooms,  delivery  rooms, 
emergency rooms, anesthetizing rooms,  corridors,  utility  rooms  and  other 
areas when used for induction of anesthesia with  flammable  or  nonflammable 
anesthetizing agents.

Critical Patient Care Area. A section (rooms, wards  or  portions  of  wards) 
designated for the treatment of critically ill patients.

Flammable Anesthetics.  Gases or  vapors  such  as  fluroxene,  cyclopropane, 
divinyl ether, ethyl chloride, ethyl ether,  and  ethylene,  which  may  form 
flammable or explosive mixtures with air, oxygen, or reducing gases  such  as 
nitrous oxide.

Flammable  Anesthetizing  Location.  Any  operating  room,   delivery   room, 
anesthetizing room, corridor, utility room, or any  other  area  if  used  or 
intended for the application of flammable anesthetics.

Patient Grounding  Point.  A  jack  or  terminal  bus  which  serves  as  the 
collection point for redundant grounding of  electric  appliances  serving  a 
patient vicinity, and  for  grounding  conductive  furniture  or  nonelectric 
equipment within reach of a patient or a person who may touch him.

Patient Vicinity. The space with surfaces  likely  to  be  contacted  by  the 
patient or an attendant who can touch him.  This represents a  space  6  feet 
beyond the reach of the patient.

Reference Grounding Point. A terminal  bus  which  is  an  extension  of  the 
equipment grounding bus and is a convenient collection  point  for  grounding 
all electric appliances, equipment  and  exposed  conductive  surfaces  in  a 
patient vicinity.

Room Bonding Point. A grounding terminal bus which  serves  as  a  collection 
point for grounding exposed metal or conductive building surfaces in a room.

517-3.  Grounding. In locations intended for occupancy  by  patients  at  any 
time, all noncurrent-carrying conductive  surfaces  of  electrical  equipment 
that are subject to personal contact shall be grounded by an insulated copper 
conductor, sized in accordance with Table 250-95, installed with the  circuit 
conductors supplying these receptacles and equipment.

  517-50.  General.

  (b) Patient Care areas shall be classified into one of the three  following 
categories:
  (1)  General  Care  Area.   Areas  where  patients  ordinarily  have   only 
incidental contact with electrical devices.
  (2) Critical Care Area, Controlled.   Areas where patients  ordinarily  are 
intentionally exposed to electrical devices, and  where  the  governing  body 
requires protection (insulation)  of  externalized  cardiac  conductors  from 
contact with conductive surfaces other than those designed for connection  to 
such cardiac conductors.
  (3) Critical Care Area, Uncontrolled. Areas where patients  ordinarily  are 
intentionally exposed to electrical devices  and  where  the  governing  body 
makes no requirements for protection of externalized cardiac conductors  from 
contact with conductive surfaces other than those designed for the purpose.

  517-51. Performance.

  (a) Any two exposed conductive surfaces in the patient vicinity  shall  not 
exceed the following potential differences at frequencies of  1000  Hertz  or 
less  measured  across  a  1000  ohm  resistance.   Exception:    Permanently 
installed x-ray equipment.
  (1) General Care Areas. 500 mv under normal operation.
  (2) Critical Care Areas, Controlled.  100 mv under normal operation.
  (3) Critical Care Areas, Uncontrolled. 100 mv  under  normal  operation  or 
under conditions of line-to-ground fault.
  (b) Special Requirements. The following  requirements  in  both  categories 
shall not apply to small portable  nonelectric  devices  such  as  bed  pans, 
chairs, and the like.
  (1) General Care Areas. Each patient bed location shall be provided with  a 
minimum of four single or two duplex receptacles, each  receptacle  shall  be 
grounded by means of an insulated copper conductor sized in  accordance  with 
Table 250-95.
  (2) Critical Care Areas. Each patient bed location shall be provided with a 
minimum of six single or  three  duplex  receptacles,  and  grounded  to  the 
reference grounding point by means of an insulated copper equipment grounding 
conductor. Each patient  bed  location  shall  be  provided  with  a  patient 
grounding point, grounded to the reference grounding point  by  means  of  an 
insulated continuous, stranded copper conductor, not smaller than No.
10. All exposed conductive surfaces of portable equipment used in the patient 
vicinity, including those on double-insulated and nonelectric beds  shall  be 
grounded to the reference grounding point. One patient bed location shall not 
be served by more than one reference grounding point.
  (7) The equipment grounding conductor for special purpose receptacles  such 
as the operation of mobile x-ray equipment shall be extended to the reference 
grounding points for all locations likely to be served from such receptacles. 
 When such a circuit is  served  from  an  isolated  ungrounded  system,  the 
grounding conductor need not be  run  with  power  conductors;  however,  the 
equipment grounding terminal of  the  special  purpose  receptacle  shall  be 
connected to the reference grounding point.
  (c) Permanently Installed X-Ray Equipment.
  (1) In addition to the grounding requirements of Article  660,  permanently 
installed X-ray systems shall have a patient grounding point as described  in 
(b) above, located as close as  possible  to  the  patient  support,  and  be 
connected to the metal frame of the patient support by a separate, insulated, 
continuous, stranded, copper conductor, not smaller than No. 4.
  (2) The patient grounding point shall be connected to the ground  conductor 
serving the X-ray equipment by an insulated, stranded, copper  conductor  not 
smaller than No. 10.
  (3) The permanently installed X-ray system including all equipment  powered 
from the X-ray generator power supply shall not be required to be powered  by 
an isolated system.  The equipment grounding conductors associated  with  the 
equipment shall have a maximum DC  resistance  of  0.025  ohms,  as  measured 
between the chassis and the patient ground point.

  517-60.  Anesthetizing Locations Classifications.

  (a) Hazardous Location.
  (1) Any room or space in which flammable anesthetics or volatile  flammable 
disinfecting agents are stored shall be considered to be a Class I,  Division 
1 location throughout.
  (2) In a  flammable  anesthetizing  location,  the  entire  area  shall  be 
considered to be a Class I, Division 1 location which shall extend upward  to 
a level 5 feet above the floor.
  (b)  Other  Than  Hazardous  Locations.  The  term  "other  than  hazardous 
locations" shall apply to any operating  rooms,  delivery  rooms,  anesthesia 
rooms, corridors, utility rooms, and other  areas  permanently  used  for  or 
intended for the exclusive use of nonflammable anesthetizing agents.
Confirmation of other than hazardous locations shall  be  accomplished  by  a 
written  policy  by  the  hospital  administration  prohibiting  the  use  of 
flammable anesthetics and posting of rooms.  In such  cases,  the  rooms  are 
excluded from the requirements of Section 517-61, 517-62, 517-63(f) (2),  and 
517-63(f) (3) as applied to X-ray systems only.

  517-61. Wiring and Equipment Within Hazardous Areas.

  (a) In hazardous areas referred to in Section 517-60, all fixed wiring  and 
equipment, and all portable equipment, including lamps and other  utilization 
equipment, operating at more than 8 volts between conductors,  shall  conform 
to the requirements of Section 501-1 through 501-15  and  Sections  501-16(a) 
and (b) for Class I, Division 1  locations.   All  such  equipment  shall  be 
specifically approved for the hazardous atmospheres involved.
  (b) Where a box, fitting or  enclosure  is  partially,  but  not  entirely, 
within a hazardous area,  the  hazardous  area  shall  be  considered  to  be 
extended to include the entire box, fitting or enclosure.
  (c) Flexible cords, which are  or  may  be  used  in  hazardous  areas  for 
connection to portable utilization equipment, including  lamps  operating  at 
more than 8 volts between  conductors,  shall  be  of  a  type  approved  for 
extra-hard usage, shall be of ample length, and shall include  an  additional 
conductor for grounding.  A storage device for the  flexible  cord  shall  be 
provided, and shall not subject the cord to bending at a radiusof less than 3 
inches.
  (d) Receptacles and attachment plugs in hazardous areas shall be listed for 
use in Class I, Group C hazardous locations, and shall have provision for the 
connection of a grounding conductor.

  517-62.  Wiring  and  Equipment  in   Nonhazardous   or   Above   Hazardous 
Anesthetizing Areas.

  (a) Wiring above a hazardous area as referred to in Section 517-60 or in  a 
nonflammable anesthetizing area shall be installed in rigid raceways or shall 
be Type MI cable, Type ALS cable, Type CS  cable,  or  Type  MC  cable  which 
employs a continuous, impervious metallic sheath.
  (b) Equipment which may produce arcs, sparks or  particles  of  hot  metal, 
such  as  lamps  and  lampholders  for  fixed  lighting,  cutouts,  switches, 
receptacles, generators, motors, or other equipment having make-and-break  or 
sliding contacts, shall be of the totally enclosed type or so constructed  as 
to prevent escape of sparks or hot metal particles.
  (f) Plugs and receptacles for connection of 250V, 50-ampere  and  60-ampere 
AC medical equipment for use in nonhazardous areas  of  flammable  anesthetic 
Anesthetizing Locations and in nonflammable Anesthetizing Locations shall  be 
so arranged that the 60-ampere receptacle will accept either the  50-  ampere 
or the 60-ampere plug.  50-ampere receptacles shall be designed so as not  to 
accept the 60-ampere attachment plug.  The plugs shall be  of  the  two-pole, 
3-wire design with a third contact connecting to the  (green  or  green  with 
yellow stripe) equipment grounding conductor of the electrical system.

  517-63.  Circuits in Anesthetizing Locations.

  (a) Except as provided in Section 517-63(f) and (g), each  circuit  within, 
or partially within, an anesthetizing location  as  referred  to  in  Section 
517-60 shall be controlled by a switch having a disconnecting  pole  in  each 
circuit conductor,  and  shall  be  isolated  from  any  distribution  system 
supplying areas other than anesthetizing locations.  Such isolation shall  be 
acceptable by  means  of  one  or  more  transformers  having  no  electrical 
connection between  primary  and  secondary  windings,  by  means  of  motor- 
generator sets, or by means of suitable isolated batteries.
  (f) Branch circuits supplying only fixed lighting fixtures in  nonhazardous 
areas of anesthetizing locations other than surgical  lighting  fixtures,  or 
supplying only  approved  permanently  installed  X-ray  equipment  shall  be 
permitted to be supplied by a conventional grounded  system,  provided:   (1) 
wiring for  grounded  and  ungrounded  circuits  does  not  occupy  the  same 
raceways:  (2) the lighting fixtures and  the  X-ray  equipment  (except  the 
enclosed X-ray tube and the metal-enclosed high-voltage leads  to  the  tube) 
are located at least 8 feet above the  floor  or  outside  the  anesthetizing 
location; and (3) switches for the grounded circuits are located  outside  of 
the anesthetizing location.
  (g) Components of an isolated power center approved for the purpose and its 
grounded primary feeder shall be permitted to be located in an  anesthetizing 
location provided it is located in an other than hazardous area.

  Note  1:  For  a  description  of  approved  permanently  installed   X-ray 
equipment, see Sections 3384,  3385,  3432,  3433,  4435,  and  4437  of  the 
Inhalation Anesthetics Standard, NFPA No. 56A-1973.

  Note 2:  Remote-control  stations  for  remote-control  switches  shall  be 
permitted in the anesthetizing location  if  the  remote-control  circuit  is 
energized from the ungrounded distribution system.

  517-65. Other Equipment.

  (b) X-ray equipment installed or operated in an anesthetizing  location  as 
defined in Section 517-2 shall be provided with approved means for preventing 
accumulation of electrostatic charges.  All X-ray control devices,  switches, 
relays, meters,  and  transformers  shall  be  totally  enclosed,  and  where 
installed or operated within a hazardous area, shall be approved for Class I, 
Group C locations.  High-voltage wiring shall be effectively  insulated  from 
ground  and  adequately  guarded  against  accidental  contact.   The  entire 
installation shall comply with Article 660.

  517-66. Grounding.  In any anesthetizing area, all metallic  raceways,  and 
all noncurrent-carrying conductive portions of fixed  or  portable  equipment 
including the conductive floor shall be grounded.

  Exception:  Equipment operating at not more than 8 volts between conductors 
shall not be required to be grounded.


                        ARTICLE 660 - X-RAY EQUIPMENT

  660-2. Definitions.

Portable:  X-ray equipment designed to be hand-carried.

Mobile:  X-ray equipment mounted on  a  permanent  base  with  wheels  and/or 
casters for moving while completely assembled.

Transportable:  X-ray equipment to be installed in a vehicle or that  may  be 
readily disassembled for transport in a vehicle.

Long-Time Rating:  A rating based on an operating interval of five minutes or 
longer.

Momentary Rating:  A rating based on an  operating  interval  that  does  not 
exceed five seconds.

  660-3. Hazardous Locations.   Unless approved for the location,  X-ray  and 
related equipment shall not be installed or operated in hazardous locations.
See Article 517, Part E.

  660-4. Connection to Supply Circuit.
  (a) Fixed and Stationary Equipment.  Fixed and stationary  X-ray  equipment 
shall be connected to the power supply by means of a  wiring  method  meeting 
the general requirements of this Code.

  Exception: Equipment properly supplied by a branch  circuit  rated  at  not 
over 30 amperes  shall  be  permitted  to  be  supplied  through  a  suitable 
attachment plug cap and hard-service cable or cord.

  (b)  Portable,  Mobile,  and  Transportable  Equipment.  Individual  branch 
circuits shall not  be  required  for  portable,  mobile,  and  transportable 
medical X-ray equipment requiring a capacity of not over 60 amperes.
Portable and mobile types  of  X-ray  equipment  of  any  capacity  shall  be 
supplied through a suitable hard-service cable or cord.  Transportable  X-ray 
equipment of any capacity shall be permitted to be  connected  to  its  power 
supply by suitable connections and hard-service cable or cord.
  (c) Over 600-Volt Supply.  Circuits and  equipment  operated  on  a  supply 
circuit of over 600 volts shall comply with Article 710.

  660-5. Disconnecting Means.  A disconnecting means of adequate capacity for 
at least 50 percent of the input required for the  momentary  rating  or  100 
percent of  the  input  required  for  the  long-time  rating  of  the  X-ray 
equipment, whichever is greater, shall be provided in the supply circuit.
The disconnecting means shall be operable from a location readily  accessible 
from the X-ray control.  For equipment connected to a 120-volt branch circuit 
of 30 amperes or less, a grounding-type attachment plug cap and receptacle of 
proper rating shall be permitted to serve as a disconnecting means.

  660-9. Minimum Size of Conductors.  Sizes No. 18 or  16  fixture  wires  as 
specified in Section 725-16 and flexible cords shall  be  permitted  for  the 
control and  operating  circuits  of  X-ray  and  auxiliary  equipment  where 
protected by not larger than 20-ampere overcurrent devices.

  D. Guarding and Grounding.

  660-47. General.
  (a) High-Voltage Parts.  All high-voltage  parts,  including  X-ray  tubes, 
shall be mounted  within  grounded  enclosures.   Air,  oil,  gas,  or  other 
suitable insulating media shall be used to insulate the high voltage from the 
grounded enclosure.  The connection from the high-voltage components shall be 
made with high-voltage shielded cables.
  (b) Low-Voltage Cables.  Low-voltage cables connecting to oil-filled  units 
that are  not  completely  sealed,  such  as  transformers,  condensers,  oil 
coolers, and  high-voltage  switches,  shall  have  insulation  of  the  oil- 
resistance type.

  660-48. Grounding.

  Noncurrent-carrying  metal  parts  of  X-ray   and   associated   equipment 
(controls, tables, X-ray tube supports, transformer tanks,  shielded  cables, 
X-ray tube head, etc.) shall be grounded in the manner specified  in  Article 
250.  Portable and mobile  equipment  shall  be  provided  with  an  approved 
grounding-type attachment plug cap.  In areas  designated  as  critical  care 
areas, X-ray equipment shall be grounded in the manner prescribed in  Section 
517-51.
   Exception: Battery-operated equipment.


 PART 8.  MEDICAL EXTREMITY X-RAY INSTALLATIONS


R 325.5361.  Purpose and scope.
  Rule 361.  (1)  This part establishes requirements  governing  the  use  of 
x-radiation in any healing arts discipline for  human  extremity  radiography 
only.  As used in this part "extremity radiography" means radiography of  the 
hand or arm excluding the shaft of the humerus or the foot or  leg  excluding 
the shaft of the femur.
  (2) This part applies to  all  registrants  who  use  x-radiation  for  the 
intentional exposure of human extremities only.
  (3) In addition to the  requirements  of  this  part  all  registrants  are 
subject to parts 1, 4 and 5 and all applicable provisions of the other parts. 
 Registrants using x-radiation for intentional human exposure other  than  or 
in addition to extremity radiography are subject to part 7.

   History: 1954 ACS 85, Eff. Dec. 3, 1975; 1954 ACS 98, Eff. Mar. 9, 1979.


      FIXED RADIOGRAPHIC INSTALLATIONS


R 325.5362.  X-ray equipment.
  Rule 362.  (1)  All x-ray tube housings in fixed radiographic installations 
shall be of the diagnostic type.
  (2) The aluminum equivalent of the total  filtration  in  the  useful  beam 
shall not be less than that shown in table I.

				TABLE I

Operating kVp						Minimum Total Filter
(Inherent plus added)

Below 50 kVp						0.5 mm aluminum
50-70 kVp						1.5 mm aluminum
Above 70 kVp						2.5 mm aluminum

  (3) If the filter in the machine is not accessible for  examination   and   
the 
total filtration is not known subrule (2) may be assumed to have been met  if 
the half-value layer is not less than
	0.6 mm aluminum at 49 kVp
	1.6 mm aluminum at 70 kVp
	2.6 mm aluminum at 90 kVp
  (4) Under conditions of subrule  (3)  for  tube  potentials  above  90  kVp 
subrule 
(2) may be assumed to have been met if the half-value layer is not less  than 
that specified in table 2 in rule 325 (5).
  (5) Beam-limiting  devices  (diaphragms,  cones,  adjustable  collimators), 
capable of restricting the useful beam to the area radiographically  recorded 
shall be provided to define the beam and shall provide  the  same  degree  of 
attenuation as that required of the tube housing.
  (6) Beam-limiting devices shall be calibrated in terms of the size  of  the 
projected  useful  beam  at  specified  source-image  distances  (SID).   The 
calibration shall be clearly and permanently recorded  on  the  beam-limiting 
device.   Calibration  of  adjustable  beam-limiting  devices  shall   permit 
reproducible settings.
  (7) X-ray systems designed for only 1 image receptor size at  a  fixed  SID 
shall be provided with means to limit the field at the  plane  of  the  image 
receptor to dimensions no greater than those of the image  receptor,  and  to 
align the center of the x-ray field with the center of the image receptor  to 
within 2% of the SID.
  (8) The size of the x-ray beam projected by  fixed  aperture  beam-limiting 
devices, except those  used  for  stereoradiography,  shall  not  exceed  the 
dimensions of the image receptor by more than 2% of the SID when the axis  of 
the x-ray beam is perpendicular to the plane of the image receptor.
  (9) The calibrated field size indicator on adjustable beam-limiting devices 
shall be accurate to within 2% of the SID.  The light field shall be  aligned 
with the x-ray field with the  same  degree  of  accuracy.   The  field  size 
projected  by  automatic  adjustable  collimators  shall  provide  the   same 
precision.
  (10) For radiographic procedures resulting in multiple views  on  a  single 
x-ray film the beam-limiting device shall limit the x-ray field size  to  the 
recorded radiographic image size within 2% of the SID.  Covering a portion of 
the radiographic film with radio-opaque material  is  not  a  substitute  for 
proper x-ray field limitation.
  (11) A device shall be provided which terminates the exposure at  a  preset 
time interval or exposure limit.  The operator shall be able to terminate the 
exposure at any time by discontinuing pressure upon the exposure switch.
  (12) Unless protective shielding is provided for the operator,  the  length 
of the exposure control switch cord or remote control location shall be  such 
that the operator shall be able to stand at least 1.8 meters  (6  feet)  away 
from the patient and the  x-ray  tube  and  out  of  the  useful  beam.  When 
protective shielding is provided,  the  operator  shall  always  be  entirely 
behind the shield during the exposure.
  (13) The  control  panel  shall  provide  positive  identification  of  the 
production of x-rays whenever the x-ray tube is  energized.   A  milliammeter 
may comply with this subrule.
  (14) The technique factors to be used during an exposure shall be indicated 
before the exposure begins, except when automatic exposure controls are used, 
in which case the technique factors which are set prior to the exposure shall 
be indicated.  On equipment having fixed technique factors, this  requirement 
may be met by permanent markings.  Indication of technique factors  shall  be 
visible from the operator's position.
  (15) On radiographic x-ray machines manufactured after the  effective  date 
of these rules a signal audible to  the  operator  shall  indicate  that  the 
exposure has ended.
  (16) X-ray equipment installed after the  effective  date  of  these  rules 
shall be installed and used in accord with the appropriate  portions  of  the 
1975 national electrical code (NFPA No. 70-1975) reproduced or referenced  in 
rule 359.  X-ray equipment installed before the effective date of these rules 
shall conform with the appropriate national electrical code in effect at  the 
time of installation.

   History: 1954 ACS 85, Eff. Dec. 3, 1975; 1954 ACS 98, Eff. Mar. 9, 1979.


R 325.5365.  Enclosures.
  Rule 365.  (1)  The degree of protection required for an enclosure shall be 
determined by the workload, use and occupancy factors  and  the  kilovoltage, 
milliamperage, mechanical movement and distance factor, and shall be  subject 
to design approval by the department.
  (2) Radiographic-room wall and floor areas exposed to the useful beam  plus 
an area extending at least 30 centimeters (1 foot) beyond shall  be  provided 
with a primary protective barrier where necessary as determined by  workload, 
use, occupancy and distance factors.
  (3) Secondary protective barriers shall be  provided  in  the  radiographic 
room ceiling and in those  walls  not  requiring  primary  barriers.   Common 
building materials often fulfill this requirement.
  (4) A fixed barrier of 1.6 millimeters (1/16 inch) lead  equivalence,  such 
as a shielded wall partition or immobilized portable shield,  is  recommended 
for operator protection.  When this protection is provided the operator shall 
be able to see and communicate with the patient from a shielded position.

   History: 1954 ACS 85, Eff. Dec. 3, 1975; 1954 ACS 98, Eff. Mar. 9, 1979.


R 325.5366.  Conditions of operation.
  Rule 366.  (1)   An  operator  shall  properly  utilize  the  beam-limiting 
devices provided to restrict the useful beam to the smallest area  consistent 
with  clinical  requirements.   Particular  care  shall  be  taken  to  align 
accurately the x-ray beam with the patient and film.
  (2) The operator shall insure the presence of  adequate  filtration  before 
any radiographic procedure.
  (3) Staff personnel routinely working  with  or  around  radiation  sources 
shall not be required by the licensee or registrant to hold film or  restrain 
patients during  radiography.   If  such  procedure  is  permitted  personnel 
exposure shall not exceed rule 205 or the procedure shall be prohibited.
  (4) When a patient must be held in  position  for  radiography,  mechanical 
supporting or restraining devices shall be available and shall be used unless 
contraindicated.  If  the  patient  must  be  held  by  an  individual,  this 
individual shall wear  protective  gloves  and  a  protective  apron  of  0.5 
millimeter minimum lead equivalence and he shall be  so  positioned  that  no 
part of his body will be struck by the useful beam and that his  body  is  as 
far as possible from the edge of the useful beam.
  (5) During each exposure, the operator shall stand at least 1.8  meters  (6 
feet) from the patient and the x-ray tube and  outside  the  useful  beam  or 
behind a suitable barrier.
  (6) Only individuals whose presence is necessary shall be permitted in  the 
radiographic room during exposure.   Each  individual,  except  the  patient, 
shall be protected by 0.5 millimeter minimum lead  equivalent  aprons  unless 
protected by an approved primary barrier.
  (7) Personnel monitoring shall be performed in controlled  areas  for  each 
individual occupationally exposed to ionizing radiation from diagnostic x-ray 
equipment.  Personnel monitoring devices, such as film  badge  dosimeters  or 
thermoluminescent  dosimeters,  shall  be  permanently   assigned   to   each 
occupationally exposed  individual.   This  monitoring  shall  be  continuous 
during employment as a radiation worker.
  (8) Personnel exposure records shall be kept on permanent available file at 
the facility where the exposure occurs.
  (9) Monitoring devices used to estimate whole body exposure shall  normally 
be worn on the chest or abdomen.  Monitoring of any  other  body  part  shall 
comply with rule 222.
  (10) Monitoring devices worn to estimate  personnel  occupational  exposure 
shall not be worn by the individual when he is exposed as a patient  for  any 
medical or dental reason.
  (11)  The  gonads  of  children  and  persons  who  have  not  passed   the 
reproductive age shall be protected from the useful beam either by the use of 
shielding (0.5 mm lead equivalent), collimation, or special gonad shields.
Special gonadal aprons (0.25 mm lead equivalent) are  commercially  available 
and recommended for patient protection from secondary radiation.
  (12) Intensifying screens shall be  employed  to  reduce  patient  exposure 
except in cases where a noticeable decrease in image  definition  may  reduce 
the clinical value of the examination.  Film and  screen  speed  combinations 
shall be carefully selected to produce  the  necessary  clinical  information 
with the least exposure to  the  patient  consistent  with  current  clinical 
judgement.
  (13) Film processing materials and techniques shall be those recommended by 
the x-ray film and processing materials manufacturers unless otherwise tested 
to  insure  maximum  information  content  of  the  developed  film.    Sight 
developing shall not be permitted except under extreme emergency conditions.
Correct temperature control and development time are  necessary  to  minimize 
radiation dose to the patient.
  (14) A radiographic x-ray system  shall  not  be  left  unattended  without 
locking the apparatus, room or building in some manner which will prevent use 
of the apparatus by unauthorized persons.

   History: 1954 ACS 85, Eff. Dec. 3, 1975; 1954 ACS 98, Eff. Mar. 9, 1979.


  MOBILE OR PORTABLE RADIOGRAPHIC EQUIPMENT


R 325.5368.  General provisions.
  Rule 368.  (1) Radiographic x-ray equipment shall comply with  the  general 
requirements of rule 362.
  (2) Mobile or portable radiographic x-ray equipment  used  routinely  in  1 
location shall be considered a fixed installation and enclosures shall comply 
with the general requirements of rule 365.
  (3) Operation shall comply with the general requirements of rule 366.

   History: 1954 ACS 85, Eff. Dec. 3, 1975; 1954 ACS 98, Eff. Mar. 9, 1979.
 

  PART 9.  DENTAL X-RAY INSTALLATIONS


R 325.5371.  Purpose and scope.
  Rule 371.  (1)  This part establishes requirements  governing  the  use  of 
x-radiation in dentistry.
  (2) This part applies to all registrants who use x-radiation  in  dentistry 
for the intentional exposure of humans.
  (3) In addition to the  requirements  of  this  part  all  registrants  are 
subject to parts 1, 4 and 5 and all applicable provisions of the other parts.
  (4) The dentist should  be  aware  of  the  requirements  of  the  Michigan 
department of labor with regard to the employment  of  persons  under  18  in 
occupations involving x-ray equipment.

   History:  1979 AC.


  CONVENTIONAL (SINGLE TUBE) INSTALLATIONS


R 325.5372.  Scope.
  Rule 372.  Rules 373 to 376 apply to installations consisting of  a  single 
x-ray source, its individual control unit, and protective enclosure used  for 
the production of intra-oral radiographs.

   History:  1979 AC.


R 325.5373. X-ray equipment.
  Rule 373. (1) The tube housing shall be of the diagnostic type.
  (2) The aluminum equivalent of the total  filtration  in  the  useful  beam 
shall not be less than 2.0  millimeter  aluminum  for  equipment  capable  of 
operating at potentials up  to  70  kVp  and  shall  not  be  less  than  2.5 
millimeter aluminum for equipment capable of operating at potentials  greater 
than 70 kVp.  The filter shall be located as near  the  window  of  the  tube 
housing as possible.
  (3) For diagnostic x-ray machines manufactured after the effective date  of 
these rules the aluminum equivalent of the total  filtration  in  the  useful 
beam shall not be less than that shown in table 1.

    TABLE 1

 Operating kVp   Minimum Total Filter
      (Inherent plus added)    Below 50 kVp   0.5 mm  aluminum    50-70   kVp 
1.5 mm aluminum  Above 70 kVp   2.5 mm aluminum

  (4) If the filter in the machine is not accessible  for   examination   and 
the total filtration is not known subrule (3) may be assumed to have been met
 if the half-value layer is not less than

 0.6 mm aluminum at 49 kVp  1.6 mm aluminum at 70 kVp  2.6 mm aluminum at  90 
kVp

  (5) Under conditions of subrule (4) for  tube  potentials  above   90   kVp 
subrule (3) may be assumed to have been met if the half-value  layer  is  not 
less  than that specified in table 2.
  (6) The half-value layer (HVL) of the useful beam for a  given  x-ray  tube 
potential shall not be less than the values shown in table 2.

    TABLE 2

 Design operating Measured potential  Half-value  layer   range    (Kilovolts 
peak) (millimeters)  (Kilovolts peak)

 Below 50  30   0.3     40   0.4     49   0.5  50 to 70   50     1.2       60 
1.3     70   1.5  Above 70  80   2.3     90   2.5     100   2.7     110   3.0
    120   3.2     130   3.5     140   3.8     150   4.1

  (7) If it is necessary to determine the half-value layer  at    an    x-ray 
tube potential  which  is  not  listed  in  table  2,  linear   interpolation
  or extrapolation may be made.  Positive means shall be provided to   insure 
that at least  the  minimum  filtration  needed  to  achieve    these    beam 
quality requirements is in the useful beam during each exposure.
  (8) Diaphragms or cones shall be provided for collimating the  useful  beam 
to a size no larger than clinically necessary  and  shall  provide  the  same 
degree of protection as required of the tube housing.  The  diameter  of  the 
useful beam at the cone tip shall not be greater than 3 inches.
  (9) Radiographic equipment manufactured after the effective date  of  these 
rules and designed for  use  with  an  intra-oral  image  receptor  shall  be 
provided with means to limit the x-ray beam so that:
  (a) If the minimum source-to-skin distance (SSD) is 18 centimeters or more, 
the x-ray field at the minimum SSD shall be containable in a circle having  a 
diameter of not more than 7 centimeters.
  (b) If the minimum SSD is less than 18 centimeters, the x-ray field at  the 
minimum SSD shall be containable in a circle having a diameter  of  not  more 
than 6 centimeters.
  (10) For intra-oral film exposures, means (e.g. cones) shall be provided to 
limit the source-to-skin distance (SSD) to not less than 18 centimeters  with 
apparatus operable above 50 kVp,  and  not  less  than  10  centimeters  with 
apparatus not operable above 50 kVp.  Open-ended  cones  are  recommended  to 
reduce scattered radiation.
  (11) Mechanical support of the tube head and pointer  cone  shall  maintain 
the exposure position without drift or vibration of sufficient  magnitude  to 
cause the need for manually restraining the tube or retaking the x-ray.
  (12) A device shall be provided which terminates the exposure at  a  preset 
time interval or exposure limit.  The operator shall be able to terminate the 
exposure at any time by  discontinuing  pressure  upon  the  exposure  switch 
except that during  serial  radiography  means  may  be  provided  to  permit 
completion of any single exposure of the series in progress.
  (13) If a recycling timer is employed, it shall not be possible to  make  a 
repeat exposure without release of the exposure switch to reset the timer.
  (14) The exposure control switch shall have a circuit-closing contact which 
can be maintained only by continuous pressure on the switch by the operator.
  (15) Unless protective shielding is provided for the operator,  the  length 
of the exposure control switch cord or remote control location shall be  such 
that the operator shall be able to stand at least 1.8 meters  (6  feet)  away 
from the patient and the x-ray tube and out of the useful beam.
  (17) The control panel shall provide positive visual identification of  the 
production of x-rays whenever the x-ray tube is  energized.   A  milliammeter 
may comply with this subrule.
  (18) On all diagnostic machines manufactured after the  effective  date  of 
these rules a signal audible to the operator shall indicate that the exposure 
has ended.
  (19) The technique factors to be used during an exposure shall be indicated 
before the exposure begins, except when automatic exposure controls are used, 
in which case the technique factors which are set before the  exposure  shall 
be indicated.  On equipment having fixed technique factors, this  requirement 
may be met by permanent markings.  Indication of technique factors  shall  be 
visible from the operator's position.
  (20) X-ray equipment installed after the  effective  date  of  these  rules 
shall be installed and used in accord with the appropriate  portions  of  the 
1975 national electrical code (NFPA No. 70-1975) reproduced or referenced  in 
rule 359.  X-ray equipment installed before the effective date of these rules 
shall conform with the appropriate national electrical code in effect at  the 
time of installation.

   History:  1979 AC.


R 325.5375.  Shielding.
  Rule 375.   Conventional  building  materials  in  partitions,  floors  and 
ceilings may provide adequate radiation shielding for dental installations.
When a conventional building structure does not provide  adequate  shielding, 
the shielding shall be increased by providing greater thickness  of  building 
materials or by adding lead, concrete, steel or other suitable  materials  to 
the walls, floor and ceiling of an existing room.  Shielding shall be subject 
to approval by the department.

   History:  1979 AC.


R 325.5376.  Conditions of operation.
  Rule 376.  (1)  Deliberate exposure of an individual to the useful beam for 
training or demonstration purposes shall not be permitted unless there  is  a 
diagnostic need for the exposure and the exposure is prescribed by a  dentist 
or physician.
  (2) The operator or the assistant shall not hold the film in place for  the 
patient during the exposure.
  (3) During the exposure, the operator shall stand at least  1.8  meters  (6 
feet) from the patient and the x-ray tube and  outside  the  useful  beam  or 
behind a suitable barrier.
  (4) Only persons whose presence is necessary to  conduct  the  radiographic 
examination shall be permitted in the radiographic room during exposure.
  (5) The operator shall direct the x-ray tube  such  that  the  useful  beam 
strikes a primary barrier or unoccupied area after emerging from the patient.
  (6) Neither the tube housing nor the cone shall  be  hand-held  during  the 
exposure.
  (7) Fluoroscopy shall not be used in dental examinations.
  (8) The exposure to the patient shall be  kept  to  the  practical  minimum 
consistent with clinical objectives.
  (9) X-ray film with a  minimum  sensitivity  of  12.0  to  24.0  reciprocal 
roentgens as specified  in  american  standards  association  speed  group  D 
(A.S.A. PH 6.1-1961) shall be used for routine dental radiography.
  (10) The x-ray beam and the film shall be aligned very carefully  with  the 
area to be radiographed.
  (11) Film processing materials and techniques shall be those recommended by 
the x-ray  film  manufacturer  unless  otherwise  tested  to  insure  maximum 
information content of the developed film.  Sight developing is not permitted 
except under extreme emergency conditions.  Correct temperature  control  and 
development time are necessary to minimize radiation dose to the patient.
  (12) A variable intensity light source  should  be  used  for  viewing  the 
finished radiograph.
  (13) A radiographic x-ray system  shall  not  be  left  unattended  without 
locking the apparatus, room or building in some manner which will prevent use 
of the apparatus by unauthorized persons.

   History:  1979 AC.


   MULTIPLE TUBE INSTALLATIONS


R 325.5378.  Scope.
  Rule 378.  Rules 379 to 381 apply to installations consisting of more  than 
1 x-ray source in the same room or of sources located  in  separate  rooms.
These installations may include 2 or more complete x-ray units  (single  tube 
units) or a combination of 2 or  more  tube  heads  operable  from  a  single 
control panel (multiple tube units).

   History:  1979 AC.


R 325.5379.  X-ray equipment.
  Rule 379.  (1)  X-ray equipment in multiple tube installations shall comply 
with the general requirements of rule 373 with regard to  each  tube  housing 
assembly and each complete x-ray unit.
  (2) When 2 or more x-ray tube heads are operated  from  a  single  exposure 
switch (multiple tube units), there shall be indication at the control  panel 
showing which tube is connected and ready  to  be  energized,  and  means  to 
prevent energizing more than 1 tube head at the same time.
  (3) For multiple tube units there shall be indication at the  tube  housing 
assembly when it is connected and ready to be energized.

   History:  1979 AC.


R 325.5380.  Shielding.
  Rule 380.   Conventional  building  materials  in  partitions,  floors  and 
ceilings may provide adequate radiation shielding for dental installations.
When a conventional building structure does not provide  adequate  shielding, 
the shielding shall be increased by providing greater thickness  of  building 
materials or by adding lead, concrete, steel or other suitable  materials  to 
the walls,  floor  and  ceiling  of  an  existing  room.   In  multiple  tube 
installations the possibility of exposure  from  multiple  sources  shall  be 
considered.  Shielding shall be subject to approval by the department.

   History:  1979 AC.


R 325.5381.  Conditions of operation.
  Rule 381.  Operation shall comply with the general requirements of rule 376.

   History:  1979 AC.


   PANORAMIC INSTALLATIONS


R 325.5383.  Scope.
  Rule 383.  Rules 384 to 386 apply to panoramic installations and protective 
enclosures.

   History:  1979 AC.


R 325.5384.  X-ray equipment.
  Rule 384  (1) X-ray equipment in panoramic installations shall comply  with 
the general requirements of rule 373 excluding subrules (8) to (13).
  (2) For purposes of this rule, "image receptor" means that portion  of  the 
x-ray film instantaneously exposed by the x-ray beam  subtended  by  a  beam- 
limiting diaphragm immediately adjacent to  the  front  of  the  radiographic 
film, if the panoramic technique requires such a diaphragm.
  (3) The x-ray tube housing shall be provided with a beam-limiting diaphragm 
which shall limit the field at the plane of the image receptor to  dimensions 
not exceeding the dimensions of the  image  receptor,  and  shall  align  the 
center of the x-ray field with the center of the image receptor to within  2% 
of the SID.
  (4) Mechanical support of the tube head and image receptor  shall  maintain 
beam alignment without drift or vibration of sufficient  magnitude  to  cause 
the need for manually restraining the tube or retaking the x-ray.
  (5) A device shall be provided which terminates the exposure  at  a  preset 
time interval or exposure limit.  The operator shall be able to terminate the 
exposure at any time by discontinuing pressure upon the exposure switch.

   History:  1979 AC.


R 325.5385.  Shielding.
  Rule 385.   Conventional  building  materials  in  partitions,  floors  and 
ceilings   may   provide   adequate   radiation   shielding   for   panoramic 
installations.  When a  conventional  building  structure  does  not  provide 
adequate shielding, the shielding shall be  increased  by  providing  greater 
thickness of building materials or by adding lead, concrete, steel  or  other 
suitable materials to the walls, floor and ceiling of an existing room.
Shielding shall be subject to approval by the department.

   History:  1979 AC.


R 325.5386.  Conditions of operation.
  Rule 386.  Operation shall comply with the general requirements of rule 376.

   History:  1979 AC.


   CEPHALOMETRIC INSTALLATIONS


R 325.5388.  Scope.
  Rule 388.  Rules 389 to 391 apply to installations consisting of  an  x-ray 
source used for the production of radiographs of the skull or related  extra- 
oral radiographs, its individual control unit, and protective enclosure.

   History:  1979 AC.


R 325.5389.  X-ray equipment.
  Rule 389.  (1)  X-ray equipment in cephalometric installations shall comply 
with the general requirements of rule 373 excluding subrules (8), (9),  (10), 
(11), and (15).
  (2) Beam-limiting  devices  (diaphragms,  cones,  adjustable  collimators), 
capable of restricting the useful beam to the area radiographically  recorded 
shall be provided to define the beam and shall provide  the  same  degree  of 
attenuation as that required of the tube housing.
  (3) Beam-limiting devices shall be calibrated in terms of the size  of  the 
projected useful beam at specified source-film distances.   This  calibration 
shall be clearly and permanently recorded on the beam-limiting device.
Calibration of adjustable beam-limiting  devices  shall  permit  reproducible 
settings.
  (4) X-ray systems designed for only 1 image receptor size at  a  fixed  SID 
shall be provided with means to limit the field at the  plane  of  the  image 
receptor to dimensions not exceeding those of  the  image  receptor,  and  to 
align the center of the x-ray field with the center of the image receptor  to 
within 2% of the SID.
  (5) The size of the x-ray beam projected by  fixed  aperture  beam-limiting 
devices (except those  used  for  stereoradiography)  shall  not  exceed  the 
dimensions of the image receptor by more than 2% of the SID when the axis  of 
the x-ray beam is perpendicular to the plane of the image receptor.
  (6) The calibrated field size indicator on adjustable beam-limiting devices 
shall be accurate to within 2% of the SID.  The light field shall be  aligned 
with the x-ray field with the  same  degree  of  accuracy.   The  field  size 
projected by automatic adjustable beam-limiting  devices  shall  provide  the 
same precision.
  (7) For radiographic procedures resulting in multiple  views  on  a  single 
x-ray film the beam-limiting device shall limit the x-ray field size  to  the 
recorded radiographic image within 2% of the SID.  Covering a portion of  the 
radiographic film with radio-opaque material is not a substitute  for  proper 
x-ray field limitation.

   History:  1979 AC.


R  325.5390.  Shielding.
  Rule 390.  (1)  The degree of protection required shall  be  determined  by 
the workload, use and occupancy factors and the  kilovoltage,  milliamperage, 
mechanical movement, and distance factor, and  shall  be  subject  to  design 
approval by the department.
  (2) Radiographic-room wall and floor areas exposed to the useful beam  plus 
an area extending at least 30 centimeters (1 foot) beyond shall  be  provided 
with a primary protective barrier where necessary as determined by  workload, 
use,  occupancy  and  distance  factors.   All  vertical  primary  protective 
barriers specified in this rule shall extend continuously from the floor to a 
minimum height of 2.1 meters (7 feet).
  (3) Secondary protective barriers shall be  provided  in  the  radiographic 
room ceiling and in those walls not requiring primary barriers.
  (4) Control apparatus for the radiographic equipment shall be shielded by a 
non-removable primary protective barrier extending to a minimum height of 2.1 
meters (7 feet).
  (5) Exposure switch location and control  shield  shall  be  oriented  such 
that, at arm's length from the exposure switch, the  operator  shall  not  be 
exposed to the useful beam, leakage radiation or any radiation which has been 
scattered only once.
  (6) The operator shall be able to see and communicate with the patient from 
a shielded position at the control panel.   When  an  observation  window  is 
provided, it shall have a lead equivalence at least equal to that required of 
the control  barrier  and  shall  be  installed  such  that  the  attenuation 
effectiveness of the barrier is not impaired.

   History:  1979 AC.


R 325.5391.  Conditions of operation.
  Rule 391.  Operation shall comply with the general requirements of rule 376 
excluding subrule (3).

   History:  1979 AC.


   MULTIPLE PURPOSE INSTALLATIONS


R 325.5395.  General provisions.
  Rule 395.  (1) This rule applies to installations consisting  of  an  x-ray 
source or sources used for 2 or more purposes described and provided  for  in 
rules 372 to 391.
  (2) X-ray equipment in multiple purpose installations shall comply with the 
applicable requirements of rules 373, 379, 384  and  389  for  each  mode  of 
operation permitted by the design of the equipment.
  (3) Shielding in multiple  purpose  installations  shall  comply  with  the 
applicable requirements of rules 375, 380, 385  and  390  for  each  mode  of 
operation permitted by the design of the equipment.
  (4) Operation in multiple  purpose  installations  shall  comply  with  the 
applicable requirements of rules 376, 381, 386  and  391  for  each  mode  of 
operation permitted by the design of the equipment.

   History:  1979 AC.


R 325.5396.  Hand-held portable dental x-ray systems.
  Rule 396. (1) X-ray equipment designed to be hand-held  shall  comply  with 
the general requirements of R 325.5373, excluding subrules (11) and (15).
  (2) The x-ray tube housing for tubes designed  to  be  hand-held  shall  be 
constructed such that the leakage radiation measured in air at a  distance  5 
centimeters from any point on the external surface shall not exceed 0.02  mGy 
(2 milliroentgens) in 1  hour  when  operated  under  conditions  of  maximum 
radiation output permitted by the design or operating characteristics of  the 
radiation machine.
  (3) Operation of a hand-held portable x-ray system shall  comply  with  the 
general requirements of R 325.5376, excluding subrules (3) and (6).
  (4) Protective shielding of at least 0.5 millimeter lead equivalence  shall 
be provided for the operator to protect the operator's  torso,  hands,  face, 
and gonads from backscattered radiation.  If the protective  shielding  is  a 
backscatter shield attached to the unit, the shield shall  be  positioned  as 
close to the patient as possible and the operator shall take care  to  remain 
in a protective position.
  (5) Each operator shall complete  the  training  program  supplied  by  the 
manufacturer and approved by the department prior to using the x-ray  unit.
Records of the training shall be maintained on file for  examination  by  the 
department.
  (6) Hand-held dental x-ray systems shall not be  used  for  routine  dental 
radiography in dental  offices.   This  equipment  shall  only  be  used  for 
portable use including use in nursing homes, home health care, or for use  on 
special needs patients.

  History: 2007 AACS.


   OTHER TYPES OF INSTALLATIONS


R 325.5397.  General provisions.
  Rule 397.  (1)  This rule applies to dental x-ray producing  equipment  and 
devices not specifically covered elsewhere by this part.
  (2) Types of dental x-ray sources and uses not specifically covered by this 
part and not exempted under rule 182 shall comply with parts 1, 4 and 5.

   History:  1979 AC.


PART 10.  VETERINARY X-RAY INSTALLATIONS


R 325.5401.  Purpose and scope.
  Rule 401.  (1)  This part establishes requirements  governing  the  use  of 
x-radiation in veterinary medicine.
  (2) This part applies to all registrants who use x-radiation in  veterinary 
medicine or research for the intentional exposure of animals.
  (3) In addition to the  requirements  of  this  part  all  registrants  are 
subject to parts 1, 4 and 5 and all applicable provisions of the other parts.
  (4) The veterinarian should be aware of the requirements  of  the  Michigan 
department of labor with regard to the employment  of  persons  under  18  in 
occupations involving x-ray equipment.

   History:  1979 AC.


  THERAPEUTIC MACHINES USED FOR VETERINARY    X-RAY TREATMENT


R 325.5402.  X-ray equipment.
  Rule 402.  The x-ray equipment shall comply with the  general  requirements 
of rules 312 and 321.

   History:  1979 AC.


R 325.5403.  Enclosures.
  Rule 403.  The enclosure shall comply  with  the  general  requirements  of 
rules 315 and 322.

   History:  1979 AC.


R 325.5404. Conditions of operation.
  Rule 404.  (1)  Operation shall comply with  the  general  requirements  of 
rule 317 excluding (2), (5), (6), and (11).
  (2) The output of the x-ray generator should be calibrated initially before 
use for the treatment of animals.  It should also be recalibrated after  each 
tube replacement and after any  changes  or  replacement  in  the  generating 
apparatus which could effect a change in the x-ray output.
Check calibrations should be made on an  annual  basis  and  records  of  all 
calibration maintained for not less than 5 years.
  (3) Patients shall not be hand-held in position for radiation therapy.
Mechanical supporting or restraining devices shall be used  if  restraint  is 
required.
  (4) A person shall not be permitted in the treatment room when the tube  is 
operated at any potential.
  (5) The x-ray tube of a contact therapy machine as defined in rule 321  (3) 
shall not be hand-held during irradiation.  When practical, a cap of at least 
0.5 millimeter lead equivalence should cover the aperture window of the  tube 
housing of such apparatus when the apparatus is not being used.
Because the exposure rate at the surface of the window of contact therapy and 
beryllium window machines may be more  than  10,000  R  per  minute,  extreme 
precautions are necessary to prevent accidental exposure to the useful beam.
  (6) Lead, lead rubber, lead foil and similar materials  used  for  limiting 
the field, should not transmit more than 5% of  the  useful  beam  under  the 
conditions at which the machine is operated for therapy.

   History:  1979 AC.


   FIXED RADIOGRAPHIC INSTALLATIONS


R 325.5405.  X-ray equipment.
  Rule 405.  (1)  All x-ray tube housings in fixed radiographic installations 
shall be of the diagnostic type.
  (2) The aluminum equivalent of the total  filtration  in  the  useful  beam 
shall not be less than the values shown in table 1.

				TABLE 1

		Operating kVp		Minimum Total Filter
	   (Inherent plus added)

		Below 50 kVp		0.5 mm aluminum
		50-70 kVp		1.5 mm aluminum
		Above 70 kVp		2.5 mm aluminum

  (3)  Beam-limiting  devices  (diaphragms,  cones,  adjustable  collimators) 
capable 
of restricting the useful beam to the area radiographically recorded shall be 
provided to define the beam and shall provide the same degree of  attenuation 
as that required of the tube housing.
  (4) Beam-limiting devices shall be calibrated in terms of the size  of  the 
projected useful  beam  at  specified  source-image  distances  (SID).   This 
calibration shall be clearly and permanently recorded  on  the  beam-limiting 
device.   Calibration  of  adjustable  beam-limiting  devices  shall   permit 
reproducible settings.
  (5) X-ray systems designed for only 1 image receptor size at  a  fixed  SID 
shall be provided with means to limit the field at the  plane  of  the  image 
receptor to dimensions not greater than those of the image receptor,  and  to 
align the center of the x-ray field with the center of the image receptor  to 
within 2% of the SID.
  (6) General purpose radiographic x-ray  systems  should  be  equipped  with 
adjustable beam-limiting devices containing light localizers that define  the 
entire field.  Rectangular beam-limiting devices are usually preferable.
  (7) The size of the x-ray beam projected by  fixed  aperture  beam-limiting 
devices, except those  used  for  stereoradiography,  shall  not  exceed  the 
dimensions of the image receptor by more than 2% of the SID when the axis  of 
the x-ray beam is perpendicular to the plane of the image receptor.
  (8) The calibrated field size indicator on adjustable beam-limiting devices 
shall be accurate to within 2% of the SID.  The light field shall be  aligned 
with the x-ray field with the  same  degree  of  accuracy.   The  field  size 
projected by automatic adjustable beam-limiting  devices  shall  provide  the 
same precision.
  (9) For radiographic procedures resulting in multiple  views  on  a  single 
x-ray film the beam-limiting device shall limit the x-ray field size  to  the 
recorded radiographic image size within 2% of the SID.  Covering a portion of 
the radiographic film with radio-opaque material  is  not  a  substitute  for 
proper x-ray field limitation.  This  subrule  does  not  apply  to  spotfilm 
devices manufactured before the effective date of these rules.
  (10) A device shall be provided which terminates the exposure at  a  preset 
time interval or exposure limit.  The operator shall be able to terminate the 
exposure at any time by  discontinuing  pressure  upon  the  exposure  switch 
except that during  serial  radiography  means  may  be  provided  to  permit 
completion of any single exposure of the series in progress.
  (11) A primary radiographic exposure switch shall be provided  which  shall 
be securely fixed such that the operator is required to  be  behind  a  fixed 
shield which will intercept the useful beam and any radiation which has  been 
scattered only once.
  (12) An auxiliary foot switch may be provided to activate the  radiographic 
tube in addition to but not in substitution of  the  requirement  of  subrule 
(11).  This auxiliary switch need not be fastened behind a fixed shield.
  (13) The control panel shall provide positive visual identification of  the 
production of x-rays whenever the x-ray tube is  energized.   A  milliammeter 
may comply with this subrule.
  (14) On diagnostic x-ray systems manufactured after the effective  date  of 
these rules, a signal  audible  to  the  operator  shall  indicate  that  the 
exposure has ended.
  (15) The technique factors to be used during an exposure shall be indicated 
before the exposure begins, except when automatic exposure controls are used, 
in which case the technique factors which are set before the  exposure  shall 
be indicated.  On equipment having fixed technique factors, this  requirement 
may be met by permanent markings.  Indication of technique factors  shall  be 
visible from the operator's position.
  (16) X-ray equipment installed after the  effective  date  of  these  rules 
shall be installed and used in accord with the appropriate  portions  of  the 
1975 national electrical code (NFPA No. 70-1975) reproduced or referenced  in 
rule 359.  X-ray equipment installed before the effective date of these rules 
shall conform with the appropriate national electrical code in effect at  the 
time of installation.

   History:  1979 AC.


R 325.5407.  Enclosures.
  Rule 407  (1) An enclosure shall be a permanent part  of  the  building  or 
equipment.  Portable shields shall not be used for permanent installations.
  (2) The degree of protection required for an enclosure shall be  determined 
by  the  workload,  use  and   occupancy   factors   and   the   kilovoltage, 
milliamperage, mechanical movement, and distance factor, and shall be subject 
to design approval by the department.
  (3) Radiographic-room wall and floor areas exposed to the useful beam  plus 
an additional area extending at least 30 centimeters (1 foot) beyond shall be 
provided with a primary protective barrier where necessary as  determined  by 
workload,  use,  occupancy  and  distance  factors.   All  vertical   primary 
protective barriers specified in this rule shall extend continuously from the 
floor to a minimum height of 2.1 meters (7 feet).
  (4) Secondary protective barriers shall be  provided  in  the  radiographic 
room ceiling and in those walls not requiring primary barriers.
  (5) Control apparatus for the radiographic equipment shall be shielded by a 
primary protective barrier which cannot be removed from a protective position 
between the operator and the radiation source during machine operation.
  (6) Movable barriers with electrical interlocks shall not  be  approved  in 
lieu of compliance with subrule (5).
  (7) The primary exposure  switch  location  and  control  shield  shall  be 
oriented so that, at arm's length from  the  exposure  switch,  the  operator 
shall not be exposed to the useful beam, leakage radiation or  any  radiation 
which has been scattered only once.
  (8) The operator shall be able to see and communicate with personnel within 
the room from a shielded position at the control panel.  When an  observation 
window is provided, it shall have a lead equivalence at least equal  to  that 
required  of  the  control  barrier  and  shall  be  installed  so  that  the 
attenuation effectiveness of the barrier is not impaired.
  (9) At times it may be necessary for personnel to remain  within  operating 
room or special procedure installations  during  radiographic  exposures.   A 
primary protective barrier shall be provided for personnel  protection  under 
these  circumstances  unless  necessary  technique  prevents  use   of   such 
protection.  This barrier may be  movable  if  necessary.   Movable  barriers 
shall not be permitted in lieu of the provisions of subrules (3) and (5).

   History:  1979 AC.


R 325.5409.  Conditions of operation.
  Rule 409.  (1)   An  operator  shall  properly  utilize  the  beam-limiting 
devices provided to restrict the useful beam to the smallest area  consistent 
with  clinical  requirements.   Particular  care  shall  be  taken  to  align 
accurately the x-ray beam with the patient and film.
  (2) The operator shall insure the presence of  adequate  filtration  before 
any radiographic procedure.  See rule 405 (2).
  (3) When a patient or film  must  be  held  in  position  for  radiography, 
mechanical supporting or restraining devices shall be available and shall  be 
used unless contraindicated.  Proper use of these devices  shall  permit  the 
operator to stand behind the primary control shield during most  radiographic 
procedures.
  (4) If the patient or film must be held by  1  or  more  individuals,  each 
individual shall wear protective gloves and body  aprons  of  0.5  millimeter 
minimum lead equivalence  as  well  as  head  and  neck  protection  of  0.25 
millimeter minimum lead equivalence.  Each person shall be so positioned that 
no part of his body will be struck by the useful beam and that his body is as 
far as possible from the edge of the useful beam.
  (5) Only individuals whose presence is necessary shall be permitted in  the 
radiographic room during exposure.  These individuals shall be  protected  as 
specified in subrule (4) unless protected by an approved primary barrier.
  (6) If an auxiliary foot switch is provided as specified in rule 405  (12), 
it shall be used only be a licensed  veterinarian  and  only  at  times  when 
sufficient  personnel  are  not  available  to  permit  use  of  the  primary 
exposureswitch specified in rule 405 (11).
  (7) To protect the feet of the  veterinarian  or  his  assistant  from  the 
primary beam while restraining patients, the underside  of  the  radiographic 
table shall be protected by at least  1.6  millimeter  (1/16  inch)  lead  or 
equivalent protection approved by the department.
  (8) Personnel monitoring shall be performed in controlled  areas  for  each 
individual occupationally exposed to ionizing radiation from diagnostic x-ray 
equipment.  Personnel monitoring devices such as  film  badge  dosimeters  or 
thermoluminescent  dosimeters  shall  be   permanently   assigned   to   each 
occupationally exposed  individual.   This  monitoring  shall  be  continuous 
during employment as a radiation worker.
  (9) Personnel exposure records shall be kept on permanent available file at 
the facility where the exposure occurs.
  (10) Monitoring devices used to estimate whole body exposure shall normally 
be worn on the chest or abdomen.  Monitoring of any  other  body  part  shall 
comply with rule 222.
  (11) Monitoring devices worn to estimate  personnel  occupational  exposure 
shall not be worn by the individual when he is exposed as a patient  for  any 
medical or dental reason.
  (12) Medical x-ray screen type films  and  intensifying  screens  shall  be 
employed to reduce patient  exposure  except  in  cases  where  a  noticeable 
decrease in image definition resulting from increased sensitivity may  reduce 
the clinical value of the examination.
  (13) Film processing materials and techniques shall be those recommended by 
the x-ray film and processing materials manufacturers unless otherwise tested 
to  insure  maximum  information  content  of  the  developed  film.    Sight 
developing is not permitted except under extreme emergency conditions.
Correct temperature control and development time are  necessary  to  minimize 
radiation dose to the patient.
  (14) A radiographic x-ray system  shall  not  be  left  unattended  without 
locking the apparatus, room or building in some manner which will prevent use 
of the apparatus by unauthorized persons.

   History:  1979 AC.


   FIXED FLUOROSCOPIC INSTALLATIONS


R 325.5411.  X-ray equipment.
  Rule 411.  (1)  All x-ray tube housings in fixed fluoroscopic installations 
shall be of the diagnostic type.
  (2) The aluminum equivalent of the  total  filtration  permanently  in  the 
useful beam shall not be less than 2.5 millimeters aluminum.
  (3) The  source-patient  distance  on  fluoroscopic  machines  manufactured 
before the effective  date  of  these  rules  should  not  be  less  than  45 
centimeters (18 inches) and shall not be less than 30 centimeters (12 inches).
  (4) Provision shall be made to intercept  the  scattered  x-rays  from  the 
undersurface of the table top and other  structures  under  the  fluoroscopic 
table if the tube is mounted under the table.  A cone or shield shall provide 
the same degree of attenuation as is required of the tube housing.
  (5) On fluoroscopic machines manufactured after the effective date of these 
rules a shielding device of at least 0.25  millimeter  lead  equivalence  for 
covering the bucky slot during fluoroscopy shall be provided.
  (6) On fluoroscopic machines manufactured after the effective date of these 
rules a shielding device of at least 0.25 millimeter lead  equivalence,  such 
as overlapping protective drapes or hinged or sliding panels, shall  be  used 
to  intercept  scattered  radiation   which   would   otherwise   reach   the 
fluoroscopist and others near the machine.
  (7) The equipment shall be so constructed that, under conditions of  normal 
use, the entire cross-section of the useful beam is attenuated by  a  primary 
protective barrier, permanently incorporated into the equipment.
The exposure shall automatically terminate when the barrier is  removed  from 
the useful beam.
  (8) On fluoroscopic machines manufactured after the effective date of these 
rules:
  (a) The entire cross section of the useful beam shall be intercepted by the 
primary protective barrier of the fluoroscopic image assembly at  any  SID.   
The fluoroscopic tube shall not produce  x-rays  unless  the  barrier  is  in 
position to intercept the entire useful  beam.   The  exposure  rate  due  to 
transmission through the barrier with the attenuation  block  in  the  useful 
beam combined with radiation from the image intensifier, if  provided,  shall 
not exceed 2 milliroentgens per hour at 10 centimeters  from  any  accessible 
surface of the fluoroscopic imaging assembly beyond the plane  of  the  image 
receptor for each roentgen per minute of entrance exposure rate.
  (b) The entrance exposure rate shall be measured in accordance with subrule 
(18).  The exposure rate due to  transmission  through  the  primary  barrier 
combined with radiation from the image intensifier  shall  be  determined  by 
measurements averaged over an area of 100 square centimeters with  no  linear 
dimension greater than 20 centimeters.  If the source is below the  tabletop, 
the measurement shall be made with the  input  surface  of  the  fluoroscopic 
imaging assembly positioned 30 centimeters above the tabletop.  If the source 
is above the tabletop and the SID is variable, the measurement shall be  made 
with the end of the beam-limiting device or spacer as close to  the  tabletop 
as it can be placed, if it is not closer than 30 centimeters.  Movable  grids 
and compression devices shall be removed from  the  useful  beam  during  the 
measurement.  For all measurements, the attenuation block shall be positioned 
in the useful beam 10 centimeters  from  the  point  of  measurement  of  the 
entrance exposure rate and between this point and the input  surface  of  the 
fluoroscopic imaging assembly.
 (9) The lead equivalence of the barrier of conventional  fluoroscopes  shall 
be not less than 1.5 millimeters at 100 kVp, 1.8 millimeters at 125 kVp,  and 
2.0 millimeters at potentials greater than 125 kVp.
  (10) A beam-limiting device shall be provided to restrict the size  of  the 
useful beam to less than the area of the barrier.  The x-ray tube  and  beam- 
limiting system shall be linked with the fluorescent screen assembly so  that 
the useful beam at the fluorescent screen  is  confined  within  the  barrier 
irrespective of the  panel-screen  distance.   For  image  intensifiers,  the 
useful beam shall be centered on the input phosphor.  It  should  not  exceed 
the diameter of the input phosphor during fluoroscopy or  cine-  recording.   
Ideally, for spot film radiography  with  image  intensifier  equipment,  the 
shutters should automatically open to the required  field  size  before  such 
exposure.
  (11) Beam-limiting devices (collimators, adjustable diaphragms or shutters) 
shall provide the same degree of attenuation  as  is  required  of  the  tube 
housing.
  (12) When the beam-limiting device is  opened  to  its  fullest  extent,  a 
minimum 1/4 inch unilluminated  margin  shall  exist  at  all  edges  of  the 
fluorescent screen when the screen is 35 centimeters  (14  inches)  from  the 
panel surface or table top, or at the fixed screen position in equipment such 
as  an  orthodiascope.   In  equipment  used  solely  for  image  intensified 
fluoroscopy, the x-ray beam  shall  not  have  dimensions  greater  than  the 
diameter of the input phosphor.
  (13) On fluoroscopic machines manufactured  after  the  effective  date  of 
these rules:
  (a) The x-ray field produced by nonimage-intensified fluoroscopic equipment 
shall not extend beyond the entire visible area of the image receptor.  Means 
shall be provided to permit further limitation of  the  field.   The  minimum 
field size at the greatest SID shall  be  equal  to  or  less  than  5  by  5 
centimeters.
  (b) For image-intensified fluoroscopic equipment, the total misalignment of 
the edges of the x-ray field with the respective edges of the visible area of 
the image receptor along any dimension of the visually defined field  in  the 
plane of the image receptor shall not exceed 3% of the SID.
The sum, without regard to sign, of the misalignment along any  2  orthogonal 
dimensions intersecting at the center  of  the  visible  area  of  the  image 
receptor shall not exceed 4% of the SID.  For rectangular x-ray  fields  used 
with circular image receptors, the error in  alignment  shall  be  determined 
along the length and width dimensions of the x-ray field which  pass  through 
the center of the visible  area  of  the  image  receptor.   Means  shall  be 
provided to permit further limitation of the field.  The minimum field  size, 
at the greatest SID, shall be equal to or less than 5 by 5 centimeters.
  (14) X-ray production in the fluoroscopic mode shall  be  controlled  by  a 
device which requires continuous pressure by the operator for the entire time 
of any exposure.  When recording serial  fluoroscopic  images,  the  operator 
shall be able to terminate the x-ray exposures at any time, but means may  be 
provided to permit completion  of  any  single  exposure  of  the  series  in 
progress.
  (15) When the fluoroscope is operated at 80 kVp, the exposure rate  at  the 
position where the beam enters the patient shall not exceed 3.2 R/mA-min  and 
should not exceed 2.1 R/mA-min.
  (16) The entrance exposure rate at the position where  the  center  of  the 
useful beam enters the patient should be as low as  is  consistent  with  the 
fluoroscopic requirements and shall  not  normally  exceed  10  R/min.   With 
modern equipment, most fluoroscopy can be carried out with entrance  exposure 
rates of less than 5 R/min.
  (17) Entrance exposure rate limits for fluoroscopic  machines  manufactured 
after the effective date of these rules shall be as follows:
  (a) Machines with automatic exposure rate control shall not be operable  at 
any combination of tube  potential  and  current  which  will  result  in  an 
exposure rate in excess of 10 roentgens per minute at  the  point  where  the 
center of the useful beam enters the  patient,  except  during  recording  of 
fluoroscopic images or when an optional high level control is provided.
When so provided, the equipment shall not be operable at any  combination  of 
tube potential and current which will result in an exposure rate in excess of 
5 roentgens per minute at the point where  the  center  of  the  useful  beam 
enters the patient unless the high level control is activated.  Special means 
of activation of high level controls, such  as  additional  pressure  applied 
continuously by the operator, shall be required to avoid accidental  use.   A 
continuous signal audible to the fluoroscopist shall indicate that  the  high 
level control is being employed.
  (b) Machines without automatic exposure rate control shall not be  operable 
at any combination of tube potential and current  which  will  result  in  an 
exposure rate in excess of 5 roentgens per minute  at  the  point  where  the 
center of the useful beam enters the  patient,  except  during  recording  of 
fluoroscopic images or when an optional high level control is activated.
Special means of activation  of  high  level  controls,  such  as  additional 
pressure applied continuously by the operator, shall  be  provided  to  avoid 
accidental use.  A continuous  signal  audible  to  the  fluoroscopist  shall 
indicate that the high level control is being employed.
  (18) Compliance with subrules (16) and (17) shall be determined as follows:
  (a) If the source is below the table, the exposure rate shall be measured 1 
centimeter above the tabletop or cradle.
  (b) If the source is above the table, the exposure rate shall  be  measured 
at 30 centimeters above the tabletop with the end of the beam-limiting device 
or spacer positioned as closely as possible to the point of measurement.
  (c) In a C-arm type of fluoroscope, the exposure rate shall be measured  30 
centimeters from the input surface of the fluoroscopic imaging assembly.
  (19) A cumulative timing device,  activated  by  the  fluoroscope  exposure 
switch, shall be provided.  It shall indicate the passage of a  predetermined 
period  of  irradiation  either  by  an  audible  signal  or   by   temporary 
interruption of the irradiation when the increment of exposure time exceeds a 
predetermined limit not exceeding 5 minutes.
  (20) On fluoroscopic machines manufactured  after  the  effective  date  of 
these rules means shall be provided to preset the cumulative on-time  of  the 
fluoroscopic tube.  The maximum cumulative time of the  timing  device  shall 
not  exceed  5  minutes  without  resetting.   A  signal   audible   to   the 
fluoroscopist shall indicate the completion  of  any  preset  cumulative  on- 
time.  This signal shall continue to sound while x-rays  are  produced  until 
the timing device is reset.
  (21) Devices which indicate the x-ray tube potential and current  shall  be 
provided.  On image intensified fluoroscopic equipment, these devices  should 
be located in such a manner that the operator may monitor the tube  potential 
and current during fluoroscopy.
  (22) All x-ray equipment shall be installed and used in accord with article 
660 of the national electrical code which is reproduced in rule 359.

   History:  1979 AC.


R 325.5417.  Enclosures.
  Rule 417.  (1)  An enclosure shall be a permanent part of the  building  or 
equipment.  Portable shields shall not be used for permanent installations.
  (2) The degree of protection required for an enclosure shall be  determined 
by  the  workload,  use  and   occupancy   factors   and   the   kilovoltage, 
milliamperage, mechanical movement and distance factor, and shall be  subject 
to design approval by the department.
  (3) For conventional fluoroscopy extraneous light that interferes with  the 
fluoroscopic examination shall be eliminated.  Dark  adaptation  normally  is 
not necessary when using image intensifiers.

   History:  1979 AC.


R 325.5418.  Conditions of operation.
  Rule 418.  (1)  Each individual present in a fluoroscopic room shall wear a 
protective apron of at least 0.5 millimeter lead equivalence.
  (2) Only individuals whose presence is needed to conduct  the  examination, 
to conduct radiation protection surveys or undergoing specific training shall 
be permitted in the fluoroscopy room during x-ray exposures.
  (3) Personnel monitoring shall be performed in controlled  areas  for  each 
individual occupationally exposed to ionizing radiation from diagnostic x-ray 
equipment.  Personnel monitoring devices such as  film  badge  dosimeters  or 
thermoluminescent  dosimeters,  shall  be  permanently   assigned   to   each 
occupationally exposed  individual.   This  monitoring  shall  be  continuous 
during employment as a radiation worker.
  (4) Personnel exposure records shall be kept on permanent available file at 
the facility where the exposure occurs.
  (5) Monitoring devices used to estimate whole body exposure shall  normally 
be worn on the chest or abdomen.  Monitoring of any  other  body  part  shall 
comply with rule 222.  Since employees involved  in  fluoroscopic  procedures 
are required to wear protective aprons and may be  subjected  to  non-uniform 
radiation fields, a dosimeter assigned to monitor whole  body  exposure  will 
not necessarily record the dose most representative of exposure to  the  lens 
of the eye.  To monitor this critical area for which the  exposure  limit  is 
the same as for whole  body,  active  blood-forming  organs,  or  gonads,  an 
auxiliary dosimeter shall be provided in accord with rule 222.
  (6) Monitoring devices worn to  estimate  personnel  occupational  exposure 
shall not be worn by the individual when he is exposed as a patient  for  any 
medical or dental reason.
  (7) The fluoroscopist's eyes should be sufficiently  dark-adapted  for  the 
visual task required before commencing conventional  fluoroscopy.   Under  no 
circumstances shall he attempt to compensate  for  inadequate  adaptation  by 
increasing exposure  factors  employed  or  by  prolonging  the  fluoroscopic 
examination.
  (8) A fluoroscopic x-ray  system  shall  not  be  left  unattended  without 
locking the apparatus, room or building in some manner which will prevent use 
of the apparatus by unauthorized persons.

   History:  1979 AC.



   MOBILE OR PORTABLE DIAGNOSTIC     X-RAY EQUIPMENT

R 325.5421.  X-ray equipment.
  Rule 421.  (1)  Radiographic x-ray equipment shall comply with the  general 
requirements of rule 405 excluding subrules (5) and (11).
  (2) Fluoroscopic x-ray equipment shall comply with the general requirements 
of rule 411 excluding subrules (4), (5), (6) and (9).
  (3) The radiographic exposure  control  switch  shall  be  located  on  the 
machine where adequate personnel protection  is  provided  to  attenuate  the 
direct and scatter radiation, or the length of switch cord shall be such that 
the operator shall be able to stand at least 1.8 meters  (6  feet)  from  the 
patient, the x-ray tube, and out of the useful beam.  A coil  type  extension 
switch cord capable of providing more than 1.8 meters (6  feet)  of  distance 
protection is recommended.
  (4) Hand-held fluoroscopic screens and others not attached to a  diagnostic 
source assembly with stable mounting shall not be used.
  (5) Image intensification shall always be provided on  mobile  fluoroscopic 
equipment.  It shall be impossible to operate mobile  fluoroscopic  equipment 
unless the useful beam is intercepted by the image intensifier.  Means  shall 
be provided to limit the source-skin distance to not less than 30 centimeters 
(12 inches).  For fluoroscopes intended  for  specific  surgical  application 
that would be prohibited at  the  source-skin  distances  specified  in  this 
subrule, provisions may  be  made  for  operation  at  shorter  source-  skin 
distances but in no case less than 20 centimeters.

   History:  1979 AC.


R 325.5422.  Shielding.
  Rule 422.  (1)  Portable shielding shall be used by the operator and others 
nearby when possible, 1.6 millimeter (1/16 inch) lead equivalent.
  (2) Mobile or portable diagnostic  x-ray  equipment  used  routinely  in  1 
location shall be considered a fixed installation and shall comply  with  the 
general requirements of rules 405 and 407 or rules 411 and 417 or both.

   History:  1979 AC.


R 325.5423.  Conditions of operation.
  Rule 423.  (1)  Operation shall comply with  the  general  requirements  of 
rules 409 and 418.
  (2) Individuals operating mobile or  portable  diagnostic  x-ray  equipment 
shall wear a protective apron of  minimum  0.5  millimeter  lead  equivalence 
unless portable shielding is provided as specified in subrule (1) of rule 422.

   History:  1979 AC.


   MISCELLANEOUS AND SPECIAL INSTALLATIONS


R 325.5425.  General provisions.
  Rule 425.  (1)  Types of x-ray sources and uses not specifically covered by 
this part and not exempted in rule 182, shall comply with parts 1, 4 and 5.
  (2) For the purpose of registering and approving veterinary x-ray producing 
equipment and devices not specifically covered by this  part  the  protective 
design, the workload, the use  factor  and  the  occupancy  factor  shall  be 
considered.

   History: 1979 AC.