f 
J  t 
kMXJIDANCE  FOR THE  3JlXiSSION OF 
CABINET  X-RAY  SYSTEM  REPORTS  PURSUANT 
TO 
21 CFR  1020.40 
v 
Compiled by: 
Ili vision of Compliance 
X-flay Pmducts Brarich 
FEBRUARY 1975 
U.S. Department of Health and Human Services 
Public Health Service 
Food and Drug Administration 
Center for Devices and Radiological Health 
Rockville, Maryland 20850  Foreword
The Office of Compliance, Center for Devices and Radiological Health (CDRH) developed this guide.  This guide will assist
manufacturers1 of electronic products which emit radiation in providing adequate reporting of radiation safety testing and
compliance with federal performance standards.  Title 21 of the Code of Federal Regulations (CFR), Parts 1002 and 1003 specify
Reporting and Notification requirements2, 3.
Reports submitted on radiation safety of electronic products must follow the appropriate guide (21 CFR 1002.7).  If the report does
not follow an applicable guide it must contain a sufficient justification for any deviations.  The submitter of the report will receive
an acknowledgment letter with the accession number we assign to the report.  Please reference this accession number in the future
when providing additional information about this model family in either a supplement or the annual report.  If a report is
incomplete or inadequate CDRH may reject it and return it for completion.  CDRH will not enter a rejected report into our
database.  Also, a rejected report will not receive an accession number.
WE DO NOT APPROVE THESE REPORTS OR THE PRODUCTS BEING REPORTED.  It is the manufacturer's
responsibility to certify that their products comply with all applicable standards (21 CFR 1010 - 1050), based on a testing program
in accordance with good manufacturing practices.  Prior to the shipment of products in interstate commerce 21 CFR 1002  requires
the manufacturer to submit the report  and to comply with all applicable importation requirements (21 CFR 1005).  If there are
deficiencies, we may disapprove the firm's quality control and testing program, determine that the product contains a radiation
defect, or determine that the product fails to comply with a standard.  We will notify the manufacturer if we make such a
determination.  CDRH may require the manufacturer to cease introduction into U.S. commerce until deficiencies are corrected, and
to initiate a corrective action program (21 CFR 1003 - 1004) for products already introduced into commerce.
Please mail your reports to the address below (FDA can not process electronic submissions at this time).  Provide the original
report with appropriate signature(s) (no facsimiles, please).  Provide extra copies only if this guide specifically requires them.
Submit the report written in the English language.  Translate any text that appears in a language other than English into English in
a complete and accurate manner.  Keep a copy of the completed report in your records.
We are making our reporting guides and other regulatory information available on the Internet under http://www.fda.gov/cdrh.  No
copyright exists for these guides.  Reproduce these guides as needed.  If you would like to comment on the reporting guides, web
site, or future electronic submissions, you may direct the comments to the address below.  If you need additional  regulations for
electronic products or medical devices, you should contact the Division of Small Manufacturers Assistance by telephone at 1-800-
638-2041 or 301-443-6597, or by facsimile at 301-443-8818.
Sincerely yours,
Lillian J. Gill
Director
Office of Compliance
MAILING ADDRESS (see 21 CFR 1002.7 for further information):
CENTER FOR DEVICES AND RADIOLOGICAL HEALTH
OFFICE OF COMPLIANCE (HFZ-307)
   ATTN: ELECTRONIC PRODUCT REPORTS
2098 GAITHER ROAD
ROCKVILLE MD  20850
1    Manufacturer (see 21 CFR  1000.3(n)) means any person engaged in the business of manufacturing, assembling, or importing electronic products.
2    Accidental Radiation Occurrences: 21 CFR  1002.20 requires manufacturers to immediately report accidental radiation occurrences (see 21 CFR
1000.3(a) for the definition).
3   Notification: Title 21 CFR Part 1003 requires manufacturers to provide Notification of Defects or Failure to Comply.  Send these notifications to the
Director of the Office of Compliance (HFZ-300). FOREWORD 
This  docqmeqt  is  intended to serve as a guide to assist manufacturers in 
the eubmiseion of initial and eupplements to initial report6 for  cabinet  x-ray 
systems  (21  CFR  1020.40).  The format selected for this guidance is that of a 
report form.  It may be used directly or it may serve as a model for  developing 
a  reporting  form.  However, if a manufacturer develops his own tpport form he 
must be eure that all information requested by the "modal" form is included  and 
keyed to this format since this information hae been interpreted by the Division 
of ComplC,mce as being necessary to satisfy, in whole or in  part,  the  initial 
and  supplemental  reporting  requirements.  In order to standardize reports and 
facilitate their review the order and organizatiop of the model form  should  be 
followed as closely as poasible.  CONTENTS 
Page 
.. .  . . .. . ..  . . . . . . . . . . . . . . . . . . . . . . . . . . ..  . . . ..  . . ..  . ..  . . ..  . . ..  ..  ..  . . 
FOREWORD..  ,  I 
..................................................... 
GENERAL  INSTRUCTIONS  111 
......................................... 
CABINET  X-RAY  SYSTEM  REPORTING FORM  1 
-  ....................... 
Part  I  Manufacturer  and  Report  Identification  .. . . .  . . .. . .   1 
Part II  -Product  Identi fic ation and Technical  Information..  ,  2 
-  ..................................... 
A  - Model  Identification  . . . . . . . . . . . . . . ..  . . . ..  . . .. .  . . . . .. . .  . . . .  2 
8  Technical  Information..  ,  3 
- 
. . ..  . . . . ..  
Part  111  Basic Sampling  and  Radiation Testing Information,.  15 
.. ... ... .. ... . .. .. . . . . . .. . .. .. .. . .. . . . .  . . .  . . .  . 
ATTACHMENT  LIST.  ,  ,  22 
-  ........................................... 
APPENDIX  A  DEFINITIONS.,  23  The  attached  model form is to be used when subn~ittictg initial reports and 
supplements to initial reports.  Definitions of these types of  reports  and  of 
several  other  items  necessary  to  properly  complete  the  form are giver. i~ 
Appendix A.  Part I of the form covers manufacturer and  report  identification, 
Part  11  covers  product identification and technical information, and Part 111 
covers the basic sampling and  testing  program.  The  form  contains  specific 
instructions  for  the  complefion  of  each part,  General instructions for the 
preparation and submiseion of  the various types of reports are given below. 
1.  One copy of Part I of the form is to accompany each report gubrniasion, 
- 
2.  Initial Reports  Information being submitted to meet the requirement$ 
of an initial report will require completion of all parts of the  form.  b 
copy  of  Part I1 (A),  Part 11 (B) and Part 111 is to be completed for each 
model cabinet x-ray system. 
- 
3.  Supplemental Reports  Any changes in information previously submitted 
in Part XI (A),  Part I1 (B) or Part 111 of this form ie to be submitted  a6 
a  supplement  to  an  initial  report.  Only  the  portione  of each part 
undergoing chaage need be submitted.  The date and accession numbar of  the 
initial report to which the supplement appliea ia to be listed ifi item 3 of 
Part I. 
- 
4.  Attachments  Throughout the guide reference is made to attachments, 
These attachments should be clearly marked according  to  the  alphabetical 
letter  indicated  in the guide,  All attachments should be placed in order 
at the end of the guide and the accompanying  attachment  list  filled  in. 
The  manufacturers  may  reference their own data identification numbers on 
this list. 
5.  All reports are to be submitted to: 
CENTER FOR DEVICES AND RADIOLOGICAL HEALTH 
OFFICE OF COMPLIANCE (HFZ-307) 
ATTN: ELECTRONIC PRODUCT REPORTS 
2098 GAITHER ROAD 
ROCKVILLE MD 20850  Center for Devices and Radiological Health 
Office of Compliance 
Division of Enforcement 111 
Electronic Products Branch (HFZ-342) 
2098 Gaither Road 
Rockville MD 20850 
Cabinet X-ray System Reporting Form 
- 
Part I  Manufacturer and Report Identification 
This  part  of  the form is to accompany each submissiop.  Only one capy of this 
part need be completed even though more than one copy of  other  parts  of  this 
form may be required to provide all the information being reported. 
1.  Manufacturer: 
Corresponding Official:  (May not be applicable for imports) 
Signature 
Name 
I 
Title 
2.  Importer:  (Complete if applicable) 
Name 
Address 
Corfesponding Official: 
Signature 
Name 
3.  Report Type: 
Initial 
Supplement to initial report, BRH 
Accession No.  submitted on 
# 
(dates) 
. 
4.  Report Date:  - 
P ~ r It1   Product  Identification and Technical  Information 
A  copy  of  Section A  and  B  Is to be  completed  for each new  cabinet x-ray  system 
being reported.  Only Section A  need be completed  to  report  additional  brand 
and/or  selling  model  numbers  of  a  system  when  all other manufacturing and 
testing information is  the  same  as  previously  submitted.  Any  information 
covered  in Part 11  (B)  and/or Part 111 of  the form that  has not been previously 
reported should be  provided  in the applicable portions  of  Part  II  (B)  and/or 
Part 111. 
A.  Model  Identification 
1.0  Product .type: 
- 
e= 
Reported pursuant  to paragraph c of  1002.61 
-  - 
check  as applicable 
Product  type 
Radiographic,  conventional source 
Radiographic,  pulsed  or flash source 
Fluoroscopic 
Radiographic and  fluoroscopic 
Screening device used  in public facilities 
(such  as baggage inspection devices) 
Other  than specified types  (describe below) 
Description  of  other product  types: 
2.0  List  the name  and model  number  of  the product  manufactured 
or imported  to which  the cabinet  x-ray  standard is app&.lcable. 
Do  not  repprt  if  the item is intended solely for export to 
countries whose  applicable requirements  are met. 
Name  of  Product 
t 
Model Number 
3.0  If  the reported model  is sold under  brand names,  other than 
those of  the manufacturer,  please  provide  the brand name,  mode? 
number,  and name  and  address of  each company  under  whose name  the 
model  is sold. 
Brand  Name  C 
Model Number  - 
- 
Address 
4.0  List a l l  uses or applications for which the model  is intended. 
5.0  Reference Verification  (check  one) 
- 
5.1  All information previously  reported  on 
in BRH  Accession  KO.  on  (date) 
is applicable to the.models  listed under  item 
2,  Part 11 (A)  of  this report.  The models 
w i l l  be  manufactured  and  tested  in accordance 
with  the procedures  reported in  the reference 
. 
document 
- 
5.2  Except  as  specifically  indicated  in SecrFon 
B  of  Part  I1 and/or  Part 111: all information 
previously  reported  in BRH  Accession  No. 
on  (date)  is applicable to the 
models  listed under  item 2,  Part  I1 (A) of 
this report.  These models w i l l  be  manufactured 
and  tested in accordance with  the proce.d ures 
~eportedi n the  referenced  document (s) 
- 
5.3  Initial submission of  information  re- 
. 
quired for cabinet  x-ray  system(s) 
8.  Technical 1nf ormatibn 
1. G  X-ray  Emission 
1.1  Is fhe  system designed to l i m i t  x-ray  emission fros the 
cabinet x-ray  system to an exposure  of  0,s milliroentgen 
in any one hour  at a point  five centimeters oureide  the 
external eurface? 
Yes  No  1.1  List  the following characteristics of  the x-ray  system 
range of  kVp  adjustment 
range of  mA  adjustment 
duty cycle  (see  definition) 
range of  timer  adjustment 
total filtration 
beam divergence  - 
 -.
beam  orientation 
1.3  Describe the type,  thickness,  and  location of  shielding 
incorporated  into the product  to l i m i t  x-ray  emission at  the 
external surface.  Provide  illustrative drawings as attach- 
ment  A. 
1.4  Describe all service adjustments and  procedures  thap 
affect radiation leakage. 
1.5  Are  any doors  included  as part of  the cabinet  x-ray 
system? , 
Yes  No 
If no,  proceed  to sectipn  1.6.  If yes,  complete the Following. 
1.5.1  Describe  the intended  purpose  of  each door. 
. 
Describe:  1.6  Are  any access panels included  as part of  the cabinet 
x-ray  eye t em? 
If! no,  proceed  to section 2 .O.  IE yes,  complete  the  follwing. 
1.6.1  Describe the intended purpose of  each  access 
panel. 
Describe : 
2.0  X-ray  co.n trols and  indicators (Provide a circuic diagram as 
attachment  B) 
2.1  tlescribe the control device(s)  for initiating and 
terminating x-ray  generation  and  the physical  location(s), 
Include the method  by which  x-ray  exposure interruption is 
accomplished  (p.g.,  release of  exposure switch,  termination 
of  preset time,  etc.)  and  the method  of  resuming operation 
following. x -ray  generation interruption by  the control 
device(s) 
Describe : 
2.2  Describe ihe characteristics,  operation,  and  location 
of  the main  power  control.  2,3  Describe  the characteristics,  operation,  and  location 
of  the key  activated control.  Include a  statement of  the 
key  capture condition. 
2.4  Can  an  x-ray  exposure greater than a period of  one-half 
eecond be made with this cabinet  x-ray  system? 
- 
Yes  N o 
2.4.1  If  yes,  are means  provided  to enable the operator 
to terminate  the exposure prior to completion of  the 
preset exposure  period?  Yes  No 
2.4.2  If  no,  are means  provided  to prevent  an  additional 
x-ray  exposure  to be made?  Yes  No 
2.5  Describe  all devices that indicate when  and  only when 
x-rays  are being generated and  that can be  viewed  from any 
location where  x-ray  generation can be initiated.  Include 
dimensicns,  location,  and  labeling. 
Describe : 
2.6  Hod  long are indicators actuated when  the x-ray  generation 
period  is less than  one-half  second? 
2.7  Does  failure of  any single component  of  the cabinet 
x-ray  system cause  fail'urc  of  more  than one x-ray  production 
indicator? 
Yes  No 
2.8  Describe  all other means which  indicate when x-rays 
are being generated  that can be viewed  from any  door, 
, 
access panel,  and  port.  Include  dimnsions  location,  and 
labeling. 
M 
Describe:  2.9  Ia  the cabinet x-ray  system designed to admit  humans? 
Yes  No 
If po,  proceed  to section 3.0.  If yes,  complete  the following. 
2.9.1  Describe a l l  exposure controls wjthin  the cabinet 
and  include  them  in the diagram provided  as attachment  R. 
Describe : 
2,9.2  Is a method provided  to reset, override, or 
bypaee the controls described  in 2.9.1  from outside the 
cabinet? 
2.9.3  Describe  the audible and  visible warning signals 
provided  in the cabinet. 
Describe : 
2.9.4  How  long are the warnings  signals activated prior 
to the first initiation of  x-ray  generation  after 
closing 'any  door  or access panel  designed  to admit 
-  - 
humans ? 
2.9.5  If any single component  of  the cabinet x-ray 
eygtem  fails, can  x-rays be  produced  without  elther the 
audible or visible warning  systems  indicating x-ray 
product ion? 
Yes  No  2.9.6  Does  a  visible signal withjn  the  cabinet  remain 
activated for the entire period of  x-ray  generation? 
2.9.7  Provide  copies  (or replicas)  of  a l l  slgns that 
arc ill.uminated within  the cabinet whjch  explain the 
meanings  of  the warning devices.  Indicate the sign 
location with pictures  and/or  drawings.  Label  these 
. 
as attachment  C 
3.0  Safety Interlocks. 
3.1  Describe  the interlock system and  provide circuit diagrams 
showing interlocks and  safety systems for each door and  each 
access panel. 
The  circuit diagrams may he included  in attachment  R or 
provided  separately as  attachment p.  Include the electrical 
and mechanical  characteristics of  each interlock device in 
the description. 
Description : 
- 
3.2  Describe  any provisions  for adjustment  of  the interlocks. 
 -.
3.3  Indicate the amount  of  door or access panel  movement 
that  is possible  prior to actuation of  the  interlock. 
3.4  Is  any part of  the circuit physically  removed  from  the 
energy supply circuit to the high  voltage genera{or  when 
a door  is opened. 
3.5  Is such  disconnect  dependent  upon  any  ~ovfngp art olher 
No 
than  the door.  Yes. 
Provide  drawings,  sketches or ngineering drawings  to 
clearly illustrate operation as attachment E. 
8  3.6  Describe how  x-ray  production  can be  resumed  after any 
safety interlock has been  activated. 
Describe:.,- 
-- - - -  - - --  - 
-.  -. 
3.7  Are  the required  interlock circuits alesigned  to insure 
that  the failt~rco f  one component  does not  result  in the 
failure of  more  than one required safety interlock? 
3.8  Provide a  circuit analysis describing the effects of 
critical. component  failure on  the  interlock syst ern.  Label 
F. 
the analysis Attachment 
. 
4.0  Warning,  Certification,  and  Identification L.abels 
4.1  Provide  an  exact  replica cf  a l l  13beh which show  any 
of  the following: 
(a)  The  certification statement, 
(b)  the name  and  address  of  the manufacturer  (or  individual 
or company  under whose  name  it is sold), 
(c)  the date and  place of  manufacturer  (these should be 
spelled out  in ful.l), and 
(d)  the model  number  and  serial number. 
Label  the repl.icas  as attachment  G. 
4.1.2  Is  this  labeling permanently  affixed to or 
inscribed on  tlre  system and  legible and accessible to 
view when  the system is fully assembled  for use? 
Yes  No- 
4.2.  Is a warning  label affixed at the 1ocati.on of  any 
control which  can  be  used  to initiate x-ray  generatiop? 
t 
-  No 
Yes-- 
4.2.1  TF,  this warning  1 abel permanently  affixed  to or 
inscribed at the location of  the control,  legible and 
accessible  to view? 
4.2.2  Provide a  copy  of  the warning label affixed at 
the control(s)  and label i:  attachment  I!.  4.3  Describe all other warnings  labels and  their locations 
and  include copies sf the labels  as  attachments 1. 
5.0  Ports and Apertures 
5.1  What  are the dimensions and  the shapee of  all entrance 
and exit ports? 
Shape  Dimensions 
5.2  What  is the shortest distance front  the primary beam to 
any  location  in the plane or perimeter  of  any  entrance or 
exit port?  (Numbers  indicate same ports  as in 5.1) 
-- 
Distance  5.3  Describe  all means  specifically provided  as part  of  the 
cabinet  x-ray  system to prevent  insertion of  any  part of  the 
body through  a port  into primary  beam. 
- -  
5.4  What  are the dimensions  and  shapes  of  all apertures? 
Shape  D imen s ions 
5.5  What  is the purpose  of  each  of  these apertures? 
(Numbers indicate same  apertures as  in 5.4)  5.6  Describe  the means provided  to prevent  the  insertion of 
any  part of  the human body  through  these  apertures?  (Number 
indicates the same  aperture  as in 5.4) 
Means :  6.0  Floors of  the Cabinet  X-ray  Systems. 
6.1  Does  the design of  the cabI.net  x-ray  system depend  upon 
the purchaser  providing a support surface that becomes  the 
floor of  the system when  installed? 
Yes  N o 
6.2  If the answer to 6.1  is yes,  describe  these installation 
requirements : 
Describe : 
6.3  Does the installation described in 6.2  constitute a 
permanent  installation? 
Yea  -No 
7.0  Ground  Fault 
7.1  Can a  ground  fault result  in generation of  x-rays? 
Yes  No  . 
J. 
7.2  Provide  a ground  fault analysis as 3ttachment 
8,O  Include- a copy  of  the information  p~cketo n  safety,  Lnstallation,  and 
maintenance procedures,  that  is supplied to users  as  required  by  1020.40 
.-*  (c) (9)  of  the Standard for each model,  as attachment K. 
9.0  ' Provide  copies  of  any  additional operating fnet ruct ions,  published 
product  technical data sheets,  specifications sheets,  applicaticns  notes, 
or  other  published  material  relating  to  product  specifications, 
applications,  radiation emission or radiation  safety,  as  attachment  L.  A 
picture  or  drawing& of  each  product  should also be  included.  rrorno~ional. 
sales literature may  be  included,  if approptiate. 
10.0  Systems  designed  primarily  for screening of  hand  carried items  in 
p b l i c  facilities. '  10.1  Describe  means  provided  to  require  operator presence at the 
control area during  generation of  x-radiation. 
Describe : 
10.2  Do  the means  described in  10.1 permit  surveillance of 
all ports and  doors? 
Yes  No 
10.2,l  If no, explain 
10 .J  Do  the means  described  in  10.1 permit  the  operatpr  to 
terminate  x-ray  generation at  any  time? 
Yea  N o 
10.3.1  If no,  explain  - 
Part I11  Basic Sampling and  Testing Information 
A.  Direct Test* 
1.0  Briefly cxp1.aiu the concept of  each direct x ray measureFent  test that 
is done  to vcrtfy covpliancc with  the  emission  l i m i t   of  the  standard. 
Include  in  t h i ~e xplanation  a  copy  of  the test mcthod(s).  Label  the 
.f. 
explpation and  test methods  as attachment 
The  teat described shall include,  but not be  limited  to: 
a.  Testing to evaluate effects of  scattering object and  placepent, 
b,  Testing to evaluate x  ray  emission prior to interruption of  x  ray 
generation through operation of  any  required safety interlock, 
c.  Testing  to  evaluate  the  effects  on  shielding from shipping, 
transporting or moving  the cabinet system, 
d.  Tceting  to  evaluate  line  voltage  fluctuations  and  critical 
component deterioration, 
e.  Testing to evaluate effects of  service adjustments and procedures, 
f.  Finn1 acceptance testing. 
2.0  At what  stnge(s)  (i.e,;  engineering pratotype,  initial production  lot 
run,  production run installation,  etc.)  in  the  design,  production,  or 
installation  of  the  cabinet x-ray  system is a direct test made  to verify 
compliance with the standard7 
- 
Test  Stage  3.0  State the limit(s)  at which  the unit would  be  rejected  for 
each  final acceptance  test. 
L i dt  : 
4.0  Describe the procedure used  to determine  the location(s)  of 
maximum radiation intensity. 
Describe : 
5.0  If  the direct test  utilizes a radiation measurement  instrument 
that scans the cabinet x-ray  system, what  is the rate of  scan 
(in cdsec)7  
Rate :. 
d 
6.0  State the tube potential,  current,  duty cycle,  beam orientation 
and  scatter conditions  that w i l l  produce  the rnaximum  external surface 
x-ray  exposure. 
tube  potential 
current  , 
beam orientation 
. 
scatter object 
- 
scatter object  position 
7.0  State the distance  (in centimeters) between  the external 
eurf ace and  the radiatih measurement  inst rumen t  8.0  In each stage,  described in 2.0,  list the percentage or 
number of  item tested. 
Stage  percentage  or Number 
9. 
B,  Radiation  Inatrumentation  Used  for Teeting. 
1.0  tnatrumente  used  for radiation measurement. 
Inet ruments 
-  -  - 
11 1  . 112  1/3 
Manufacture t 
Model  Number 
Type of  Instrument 
Precision of Instrument 
Accuracy  of Instrument 
Reeponse  Time 
Energy  Dependence 
Angular  Response 
Exposure  Rate  Dependence  8 
Range 
Effective Measurement  Arda  2.0  Calibration of  Instrumenfs 
2.1  Interval of  time between  calibration 
2.2  Method  of  calibrati.on,  including accuracy and source 
of  calibration 
2.3  Verification procedure -1sed to assure proper day  to 
day  operation of  Lnstmmentation 
C.  Indirect Testing 
1.0  If  the  test method  used  to monitor compliance with the 
emission  l i m i t  performonce  requirement  is other than  the direct 
measurement  described above,  describe the wthod and  attach a 
copy  of  ~11et est procedure  lobeled as attachment 5  In addition, 
- 
provide  the basis for the indirect  thod  (any method other than 
R  radiation exposure measurement) ; explain wily  it is an  aqcurate 
indicatlm of  compliance with  the emission requirements,  and 
submit  the technical data wn$ch  supports this conclusion, 
2.0  Specify the primary  purpose  of  each indirect test: 
- 
Tee t  Purpose  3.0  Specify the stage(s)  in the  design,  production,  or inetal- 
lation of  the system that  the indirect  test is made. 
- 
Test 
4,O  For any  test whose purpose  is acceptance  or  rejection  of 
the system,  specify  the  rejection limit  of  the product. 
- 
Test  Rejection Limit 
5.0  Specify who  his the  responsibility  For  conducting  these  tegts. 
Specify:  6.0  For  eac: h  test conducted  for t: he purpase of  acceptance, 
specify the actual. number  of  units tested  nnd  the proportion of 
production output which  that number  represents. 
- 
Test  #Tested  proportion of  Production 
. 
. 
D.  Sampling 
For  each  production  line  test  performf?d !or  the purpose of  deteyminjmg 
product  acceptability on less than  100 percent  of  the output,  ae attachment 
- 
0 answer  the following: 
1  Specify  the sampling plan used  and provide  the parameters  of  the plan 
(i.e.,  lot size, sample size, acceptance criteria,  etc.).  If  the  sarnpling 
plan  is  obtained  from  a  set  of  standard  sampling  tables,  indicate the 
source rind  type of  plan.  If the sampling plan  was  designed  specifically 
for  this appl.ication,  indicate the requirements which were  established  for 
the plan and  the assumptions used,  and whether  acceptance criteria is based 
upon  attributes or variables. 
2.  Describe  the procedure used for selecting the eomple and  indicate how 
randomness  is assured. 
3.  For each test or inspection specify  the quality characteristics  and  the 
epecification l$mit(e)  by  which acceptable quality  is  dfstinguislled  from 
unacceptable. 
4.  Provide  the operating characteristic  (O.C.)  curve of  the sampling plan. 
5.  Specify the distribution assumed  and  the procedures  used  fon computing 
acceptance probabilities  for the O.C.  curve of  the sampling plan. 
6.  Specify  the  producer's  and  consumer's  risk of  the sampling plan and 
indicate at what  quality level each applies. 
7.  Describe  the  action  taken i f  the sampling plan  leads to a  rejection 
decision. 
Critical Component  Testing 
P, 
As  attachment  @ 
1.  describe  a l l   applicable  qualfty  control and  testing procctlures  for 
criticaJ components  conducted  prior to installation of  the  components 
into  your  product  bhich  you  consider  a  necessary and  vital port oE 
your testing program  to assure compliance with  the Federal Performance 
Standard.  This sha'l  include,  but  not be  limited  to,  incoming  insp~c- 
tion and/or  sub-assembly  testing  cf  such  items  as  x-ray  sources, 
pressure  pads,,  interlock  switches,  relays  and  shielding components. 
Where  applicable,  t k  description shall include: 
a.  Vendor  quaLification  requirenents.  b.  Incoming  inspection procedures,  accept/reject  criteria, 
and  lot and  sample size if not  100  percent  tested.  If 
100 percent  tested,  so state. 
c.  Corrective action following unit  or lot rejection. 
2.  Describe a l l  applicable  life testing procedures on  the x-ray  system 
or on  those critic.-1.  components  incorporated  into the x-ray  system 
which you  consider a necessary  and  vital part of  your test4ng pro- 
gram to assure compliance with the Federal  Ferfortnance Standard 
for the life of  the product.    his  description shall include,  but 
not be limited to the following information: 
a.  The  State(s)  in the development  or production of  a  specific 
.model or design when  life testing is conducted on  the system 
. 
or critical component 
b.  A  copy  of  the life testing protocol,  including the test 
method  used.  If previously  addressed,  reference may  be 
made  to your response  to other appropriate sections of 
your report. 
c.  The period of  time  (e.g.  years)  relative to use  of  the unit 
at an  installed site which  the life testing represents. 
I?.  Test Results:  As  appendix Q  provide: 
1.0  The result8 of  Quality Control testing to date as foilowst 
1.1  The  numerical  results  of  the direct  radiation  tests upon  which 
you base your  certification,  including:  a)  date of  the test, b) 
state  of  development,  production  or installation et which  the 
test was  made. 
1.2  A  sumnary  of  the  numerical  results of  direct andlor indirect 
quality control tests of  production  line units. 
1.3  Where  sufficient  data  are  available,  the  mean,  range,  2nd 
standard  deviation of  each type of  measurement.  If  these  values 
are  unavailable,  other representative  statistics Gr expiess1m.s 
or results may  be  reportd. 
2.0  Summary  results  of  tests  1-rformed  to  determine  "worst  case" 
conditions  for x-ray  emission  2':   he  external surface of  the  cabinet 
x-ray  system. 
3.0  Sumnary  of  resuits of  critical component  testing. 
4.0  Summary of  results  of  critical component  or system  life testing. 
5.0  Describe  chaiiges  in  critical  components  occurring  with time that 
affect  the  performance  of  the  unit  with  respect  to  applicable 
performance  requirements.  ATTACHMENT  LIST 
(check  a l l  that  are attached  including any added  to provide information 
not spedf icdly i dent ifl ed below) 
Vanufacturer' s  Own  Data 
Identification Number 
- 
A.  Shielding Drawings 
- 
B.  Circuit Diagrams 
- 
C.  Signs Within  the Cabinet 
- 
D.  Interlock SystcnrCircuit Diagram 
- 
E.  Drawings  of  Disconnect  Interlock 
F.  Analysis  of Interlock System 
Component  Failure 
- 
G.  Certification and  Identification 
Labels 
- 
H.  Control Warning  Labeis 
- 
1.  Other Warning  Labels 
- 
J.  Ground  Fault Analysis 
- 
K.  Users Information 
- 
L.  Other Information  and Data 
M.  Direct Test Pkthods 
N.  Indirect Testing 
-  t 
0.  Sampling 
-P.   Critical Component  Tes.t ing 
- 
Q.  Test Results 
Note:  This sheet, completed  as applicable,  is to accompany  each 
report.  Appendix  A  - Definitions 
The  definitions of  report  types  and  several other terms  given below  are provided 
for use with the general  guidance to ansure proper  completion  of  the  attached 
model  form and  satisfactjo n  of  reporting requirements. 
- 
1.  Initial  R e p ~ t   The  first  report  from a manufacturer to BRH  on  2 
particul.ar model  of, product.  It  mus t  provide  comp2.ete  information  on  the 
manufacturing and  testing program  that  a manufacturer  is employing. 
- 
2.  Supplemental. Report  A  report  that provldes  details of  any additions, 
deletions,  corrcrtions,  or changes  to information  previously  mbmitted  in  an 
initial report.  ~ e ~ o rotfs  t his  type are tb be  designated  as supplements  to the 
report  (referenced by  BRB  Acccsnion  Number  and  submission  data)  where  the 
Information being  changed was  previously  submitted. 
3.  "Access  panel"  means  any  barrier  or panel which  is designed  to be 
- 
removed  or opened  for maintenance  or scrvicc:  purposes,  requires tools  to  open, 
and  permits  access  to the interjor of  the cabinet. 
4.  "Aperture"  means  any  opentng  in the outside ~urfacno f  t \ ~ ec abinet, 
other that a port, which  remaim  open  during generation of  x  radiation. 
5,  "Cabiilet  x-ray  systcm"  means  an  x-ray  Ryetern with the x-ray  tube 
instal.led  in en enclcaure (hereinafter termed  "cnbinet")  whtch,  f-ndcpendently  of 
existing architectural structures except  the floor on which  it may  be  placed,  i s  
intended to contain nt  ].east  that  portion  of  a  material  belng  irradiated; 
provide  radiation  attenuation,  =$  exclude personnelfrom  its interior durinp, 
generatizof  5  radiation.  It  would  include  all  x-ray  eystems  designed 
primarily  for  the inspection of  carry-on  baggage  at airline.,  railroad,  and bus 
 terminal.^,  end  in ~imilarf acilities.  An  x-ray  tube wed within a shielded part 
.-of a  building,  or  x-ray  equipment  whicli  may  temporarily  or occasionally 
incorporate portable  shielding is not  considered  a  cabinet x-ray  system. 
6.  "Door"  means  any harrier which  is designed to be movable  or opened  for 
routine operation purposes,  does  not  generally  require  tools  to  open,  and 
permits  access  to  the interior  of  the cabinet.  For  the purposes  of  p7:-,-;raph 
(c)(4) (1) of  this section,  inflexible hardware  rigidly  affixed to the door  si~all 
-.c 
be considered part of  the door. 
7.  "Duty  Cycle"  means  the amount  of  time  x rays  can be  generated or the 
number  of  x  ray pulses that can be  gcneratec!  in any hour,  the l i m i t  of  which  is 
determined by the design  of  the  x  ray  system. 
8 
8.  "Exposure"  means  the  quotient  of  do by  dm  where  dC)  is the absolute 
value of  the total charge of  the  ions of  one  sign produced  in air when  all  the 
electrons  (negatrons agd  positrons)  liberated by photons  in o  volume  element  of 
air having mass  dm  are completely  stsppcd  in air. 
9.  "External  surface"  means  the  outside  surface of  the cabinet x-ray 
system,  including the high  voltage  generator,  doors,  access  panels,  latches, 
controls  knobs,  and other permanently  mounted  hardware  and  inc1udir.g  the plane 
across any  aperture or port. 
10.  "Floor"  means  the underside  external surface of  the cabinet.  11.  "Ground  fault"  means  an  accidental  electrical  grounding  of  an 
electrical conductor. 
12.  "Port"  means  any opening  in the outside surface of  the cabinet which  is 
designed to remain  open,  during  generation  of  x  rays,  for  the  purpose  of 
conveyfng  materfal  to be  irradiated into and  out of  the cabinet,  or for partial 
insertion  for i rradia tion of an  ohlect whose  dimensi.onsdo  not  permlt  complete 
. 
insertion into the cnbinct 
13,  "Primary  beam" means  thc: x  rndiatjon emitted directly from the  enrget 
and  passing through  the window  of  the x-ray  tube. 
14.  " ~ a f e ti~nt erlock"  means  a  device which  is intended to prevent  the 
gcner~tiono f  x  radiation when  access by  any part  of  the  human  body  to  the 
interior of  tho catrinet  x-ray  system through  a  door or accees panel is possible. 
15.  "X-ray  system"  means  an assemblage of  components  for the controlled 
generation of  x  rays. 
16.  "X-ray  tube"  means  any  electron  tube  which  is  designed  for the 
conversion of  electrical energy into x-ray  energy.