HHS Publication  FDA 88-8234
WHO  Collaborating  Centers  for:
.Standardization  of Protection
Against  Nonionizing  Radiations
.Training  and  General  Tasks in
Radiation  Medicine
.Nuclear  Medicine
March  1988
Supersedes  FDA 84-8234
u.s.  DEPARTMENT  OF HEALTH  AND  HUMAN  SERVICES
Public  Health  Service
Food  and  Drug  Administration
Center for Devices and Radiological  Health
Rockville,  Maryland  20857 FOREWORD
In  October  1982,  the  Food  and  Drug  Administration  established  the  Center  for
Devices and Radiological  Health  (CDRH) by merging the  Bureau of Medical Devices and
the Bureau of Radiological  Health.
The Center  develops and implements  national  programs to  protect  the public  health
in the fields  of medical devices and radiological  health.  These programs are intended to
assure the  safety,  effectiveness and proper labeling of  medical devices, to  control
unnecessary human exposure to  potentially  hazardous ionizing  and nonionizing radiation,
and to ensure the safe, efficacious  use of such radiation.
The  Center  publishes the  results  of  its  work  in scientific  journals  and  in its  own
technical  reports.  These  reports  provide  a  mechanism  for  disseminating  results  of
CDRH and contractor  projects.  They are sold by the Government Printing  Office  and/or
the National  Technical  Information  Service.
Also,  CDRH technical  reports  in radiological  health are made available  to the World
Health  Organization  (WHO) under a memorandum of  agreement  between WHO and the
Department  of  Health  and  Human  Services.  Three  WHO  Collaborating  Centers,
established  under the Bureau of Radiological  Health,  continue  to function  under CDRH:
WHO Collaborating  Center  for  Standardization  of  Protection  Against  Nonionizing
Radiations;
WHO Collaborating  Center  for Training  and General Tasks in Radiation  Medicine;
and
WHO Collaborating  Center  for  Nuclear  Medicine.
We welcome  your comments and requests for  further  information.
Center for Devices and
Radiological Health
ii PREFACE
The Performance  Standard for  Sunlamp Products (21 CFR  1040.20) became effective
May 7,  1980, and was amended effective  September  8,  1986.  Sunlamp products  and
ultraviolet  lamps  manufactured  on or  after  that  date  must  conform  to  the  applicable
provisions  of the standard.  In addition,  manufacturers  are required  to  certify  that  their
products  comply  with  the standard and to  furnish  reports,  to the  Center  for  Devices and
Radiological  Health,  that  clearly  substantiate  the  product's  compliance.  Because sun-
lamp products  are also medical devices,  they are subject to the  Medical Device  Amend-
ments to the  Federal  Food, Drug, and Cosmetic  Act,  including  the Good Manufacturing
Practices  (GMP) regulations  developed  under  the  authority  of  that  Act.  All  manu-
facturers  of  sunlamps and sunlamp products  and ultraviolet  lamps  must  establish  and
implement  GMPs to  ensure that  the devices  conform  to  their  specifications,  and imple-
ment  quality  control  procedures  to  ensure compliance  with  the  Federal  performance
standard.
This guide has been prepared to  assist manufacturers  in satisfying  the G MP require-
ments  and  in  developing  and  implementing  quality  assurance  programs,  including
appropriate  testing.  This  guide also provides  what  we believe  to  be fair  and standard
criteria  by which  manufacturers'  programs  will  be evaluated.  Because of  variation  in
product  designs and manufacturing  processes, a detailed  step-by-step  protocol  would be
of limited  application.  The purpose here, therefore,  is to set forth  a general  description
of  the  procedures  and  philosophy  of  quality  assurance  as  appropriate  for  sunlamp
products  and ultraviolet  lamps.  This  document  is intended  for  use in conjunction  with
the  "Reporting  Guide  for  Initial  Reports  and  Model Change Reports  on Sunlamps and
Sunlamp Products."
We  strongly  emphasize  that  the  manufacturer  may  adopt  other  alternative  pro-
cedures that  are  equivalent  to,  or are as effective  as, those  methods described  in this
guide.  Each manufacturer's  test procedures and testing  program will  be evaluated  on an
individual  case-by-case  basis.  If  the  alternative  procedures  constitute  good manufac-
turing  practices  and  provide  adequate  safeguards  to  ensure  compliance  with  the
standard,  the  Center  for  Devices and Radiological  Health  (CDRH) would have no reason
to disapprove such a program.  .
However,  neither  the  fact  that  CDRH did  not disapprove a testing  program,  nor the
fact  that  such a program was established pursuant to this guide, relieves  a manufacturer
from  his obligations  to  comply  with  the  Radiation  Control  for  Health  and Safety  Act  of
1968 and the Federal Food, Drug, and Cosmetic  Act  as amended.
Walter E. Gundaker
Director
Office  of Compliance
UI  CONTENTS
~
Foreword ii
Preface iii
Abstract vi
1. Quality AssuranceP  rogram. 1
1
EOleDVAbPmauojeeldceidcruintsti mttiovysnei  tnyn etal tion  Procedures.  of  of Training..Measuorfe ment.a   QPuaroligtyr am. and  Records.  Assurance  Program.  2
2
3
3
3
2. PreproductionE valuation. 4
4
EDnegsiin~e~enr iRnge viewa.n d  Prototype  Testing  and  Evaluation.
4
3. Componentsa nd ProductionT esting. 5
5
QQSCTPuaueoramaosmlndtil tp?tuaioltctiainntvtigoeiev,nn  e t   Conditions  Audit, TesTtEeinvsgati.nl uga.t Tioens ting.  for and  DetermiRnaetcioycnl ing.and  Testing.  of  Compliance.  6
6
7
7
8
9
References
Appendixes
A.  Design Considerations for Compliance with the SunlampS  tandard. 11
15
B.  Procedures for Laboratory Compliance Testing.
C.  FDA Policy on Maximum Timer Interval and ExposureS  chedule. 25
" ABSTRACT
Office  of Compliance.  Quality  Control  Guide  for  Sunlamp Products. HHS Publication
88-8234 (March  1988) pp. 30.
Sunlamp  products  and  ultraviolet  lamps  manufactured  on  or  after  May 7,
1980 must  conform  to  applicable  portions  of  a performance  standard (21 CFR
1040.20, amended effective  September 8,1986),  and their  manufacture  must be
in accord  with  the  medical  devices Good Manufacturing  Practices  (GMP) regu-
lations  promulgated  under  the  Food,  Drug,  and Cosmetic  Act  (FD&C).  This
guide is intended to assist manufacturers  of these products  in satisfying  both the
GMP requirements  and in developing  and implementing  quality  assurance (QA)
programs.  This guide provides the criteria  and the underlying  philosophy used by
FDA to evaluate  manufacturers'  QA programs.  This document is intended  to be
used in conjunction  with  "Reporting  Guide for Initial  Reports and Model Change
Reports  on Sunlamps and Sunlamp Products."
I
\
Vl QUALITY  CONTROL GUIDE FOR SUNLAMP PRODUCTS
1. QUALITY ASSURANCEP ROGRAM
1.1  ELEMENTS OF A QUALITY  ASSURANCE PROGRAM
A  viable  quality  assurance  program  ensures the  performance  of  a  product  at  a
designated  level  at  the  time  of  manufacture  and  throughout  its  useful  life.  It  is
essential  for  a  manufacturer  to  establish  such a  program  to  ensure compliance  of  a
product  with  the  Federal  performance  standard  and  its  conformance  with  design
specifications.  The adequacy of a specific  quality  assurance and testing  program  must
be judged  solely  on its  own  merits  and  applicability  to  the  product.  The  essential
elements  of a quality  assurance program include the following:
1.  proper  organization,  personnel,  facilities,  and administrative  procedures  to  en-
sure an objective  and defensible  program;
2.  preproduction evaluation and testing  of the product and testing  of components
and material  obtained  from  other manufacturers;
3.  valid  measurement techniques, calibrations,  and  treatment  of  measurement
uncertainties;
4.  testing  and evaluation  of the  product  during and after  production  and statistical
analyses of data (the establishment  of confidence  limits  and rejection  criteria  are
important  components of such an evaluation);
5.  procedures  to  ensure  that  only  accepted  units  are  distributed  and  that  any
rejected  units,  if  modified  and  recycled  back  into  the  production  sequence,
undergo the  same level  of  scrutiny  as other  units  that  have  been found  accep-
table;
6.  an audit procedure to measuret he degree of conformance and the effectiveness
of the quality  assurance program,  including  product audits;
7.  lifetime  and  reliability  testing  procedures  or  other  suitable  means  to  determine
whether  the  product  will  continue  to  meet  its  design  specifications  during  its
usefullif  e;
8.  a continuous  review  of the product's  performance  throughout  its useful  life  and a
procedure  to ensure that  any problems discovered  are corrected,  and that  appro-
priate  design  changes  are  made  to  eliminate  them  from  subsequent  units
produced;
9.  documentation  control  to assure that  all  manufacturing,  component,  and finished
product  specifications  adequately  renect  the  product  design  and  provide  an
effective  and  consistent  mechanism  for  changes  of  specifications  or  quality
control  procedures; and
10.  quality  control  records,  including  a device  master  record  and a device  history
record. 1.2  OBJECTIVITY  OF PROGRAM
The  quality  assurance  program  should  be  carefully  designed  and  administered  to
ensure the  objectivity  of  the  program.  Certain  safeguards  against  personal  prejudice
and conflicting  interests  should be built  into  the  system to avoid biased decisions.  This
may present  a problem  in small  manufacturing  firms  that  employ  only a few  persons.
However,  the division  of responsibility  between production  and quality  control  personnel
should be maintained.  This  may be accomplished,  for  example,  if  one person, who is
responsible  for  the  receiving,  inspection,  and  accountability  of  components,  is  also
designed  responsible  for  in-process  checks  and finished  product  inspection.  Another
person should be held responsible for  all the  production  processes.  This  arrangement  (or
similar  ones) may sustain the  objectivity  of the  quality  control  program  by dividing  the
responsibilities.
1.3  DOCUMENTATION  AND RECORDS
Complete  documentation  of  the  quality  assurance program  must be  maintained  as
required  by 21  CFR  1002.30.  This  should include  such items  as description  of  tests
performed  and  their  sequence,  description  of  the  measurement  instrumentation  and
techniques,  rejection  criteria  or confidence  limits  and justification  for  choosing such
limits,  methods  of data  analysis and sampling plans.  If  all the  units  produced are  not
tested,  a  sampling  technique  must be used and  must be scrupulously  documented  and
followed.  Standardized  forms  for  data  recording  should be used.  The  forms  should
provide  space for logging  all  information  relevant ,to the  product  and the test,  including
the  product  model and serial  numbers, date  of  test,  date  of  manufacture,  samples per
lot,  results  of test,  identification  of personnel performing  and reviewing  the  test,  and
model and serial  numbers of test  instruments.  A device  master record  as required  by 21
CFR 820.181  must be established  for  each type  of device  and include,  or  refer  to  the
location  of,  the information  concerning:
1.  the device specification, including drawings and components pecifications;
2.  production  process specifications,  including  the  appropriate  equipment  specifi-
cations,  production  methods, and production  procedures;
3.  packaging and labeling specifications;  and
4.  quality  assurance  procedures  and  specifications,  including  quality  assurance
checks used and the quality  assurance apparatus used.  The device  master record
shall be prepared, dated, and signed by a designated individual(s).
A device  history  record  as required  by 21 CFR  820.184 must also be maintained  and
it  shall  include,  or  refer  to  the  location  of,  the  information  concerning  the  dates  of
manufacture,  the quantity  manufactured,  the quantity  released for distribution,  and any
control  number used.
Among  small manufacturers  of sunlamp products,  the  manufacturing  process may be
limited  to assembling components into the final  product,  and there  should be no problem
with  communication  and managing operations.  In this  situation,  written  manufacturing
procedures  may be reduced  to  a practical  extent.  In some cases, training  and work
experience  may be considered  valid  substitutes  for  written  manufacturing  procedures.
However,  manufacturers  must still  ensure uniformity  of procedures and keep records of
test  results  necessary to ensure the quality  of the product.
2 Records required  by the  Radiation  Control  for  Health  and Safety  Act  are to be kept
for  5 years (21 CFR  1002.31(a, and for  no less than 2 years  if  required  by the  Food,
Drug, and Cosmetic  Act (21 CFR 820.180(b.  Test records, complaints,  trends analyses,
failure  analyses, and audits  should be used to  identify  and provide  solutions  to  quality
assurancep roblems.
1.4  VALIDITY  OF MEASUREMENT
A valid  program of  measurements made as part  of quality  assurance testing  involves
periodic  evaluation  of  the  test  methods and calibration  of the  instruments.  A schedule
to  recalibrate  measuring  instruments  against  an acceptable  standard  is  important  to
ensure a consistent  measurement capability.  Calibration  services  from  the  instrument
manufacturer  or other qualified  outside sources, with  traceability  to  National  Bureau of
Standards  primary  measurement  standards,  should be used when adequate  calibration
facilities  are not available  within  a company.
The  instrumentation  should be carefully  specified  and selected  to  ensure that  it  is
capable of performing  the tests required  by the standard.  For example, instruments  for
ultraviolet  (UV) radiation  measurements should have  sufficient  spectral  sensitivity  in
the  UV region to  measure the anticipated  radiation  levels  from  the product.  After  the
measurement  instruments  have  been obtained,  they  need to  be  evaluated  for  proper
performance  and operation.  Control  charts  and logs  of  instrument  performance  and
calibrations  are essential,  as well as service and maintenance schedules.  Any changes of
the  operator,  or  in the  instrument,  its  components,  its  techniques  of  use,  calibration
standards,  or  other  relevant  components of  the  measurements  system should be docu-
mented.
..
~;: 1.5  AUDIT  PROCEDURES
The purpose of the quality  audit is to check the degree of conformance  of the quality
control  procedures  and  the  effectiveness  of  the  quality  assurance  program,  and  to
ensure  that  all  procedures  established  are  adequate  and  consistently  followed.  The
quality  audits  are  in  addition  to  the  routine  quality  assurance  program  and  should
include,  but  not  be  limited  to,  product  audits.  A  product  audit  is  an  independent
evaluation  of  product  quality  to  determine  if  the  product  complies  with  the  standards
and  if  the  product  conforms  to  design specifications.  Random sampling  is  the  only
acceptable  method  in selecting  units  for  product  audit.  The person responsible  for  the
audit  should  not  have  responsibility  for  the  matter  being  audited  but  must  have
sufficient  training  and experience  in the  manufacturing  process and testing  procedures.
For small  manufacturers,  a simple  checklist  with  appropriate  instructions  may suffice.
Documentation  of  audits  and their  results  must be kept;  results  of  findings  should be
reviewed  by management.  Audit  frequency  should be consistent  with  findings,  but the
interval  between audits should not exceed 1 year.
1.6  PERSONNEL TRAINING
All  quality  assurance and production  personnel  shall have the  necessary training  to
perform  their  assigned  responsibilities  adequately.  They  should  have  a  thorough
understanding  of their  jobs and be made aware of defects  and errors  likely  to be encoun-
tered  in performing  their  assigned functions.
3 2.  PREPRODUCTIONE VALUATION
Preproduction  evaluation  and  testing  should  include  a  review  of  the  design,
evaluation  of  components  and  material  obtained  from  other  manufacturers,  and
engineering  and  prototype  testing  to  confirm  that  the  product  as designed  can  be
manufactured  in  compliance  with  the  standard  and  in  conformance  with  the  design
specifications.
2.1  DESIGN REVIEW
Before  the  manufacture  of the  product  begins, the  product  design must be reviewed
to  determine  if  the  product  will  comply  with  the  Federal  performance  standard  and
other applicable  criteria  for  product safety,  including  electrical  and mechanical safety.
This  review  allows  the  manufacturer  to  perform  a  step-by-step  evaluation  of  the
requirements  for  the  product  and the  means used to  fulfill  these  requirements.  In
addition  to the performance  requirements,  the conditions  and environments  under which
the  product  will  be used should be considered carefully.  For example,  if  a product  is
intended to be used at a commercial  facility  and an alternate  timer  such as a coin box is
permitted,  then a mechanism must be incorporated  into the coin box to  allow the user to
terminate  exposure before  completion  of the  timer  cycle  and to  prevent  the timer  from
operating  continuously  in excess of  the  recommended  maximum  exposure time.  The
coin  box  timer  must  also  provide  intermediate  exposure  times  compatible  with  the
recommended  schedule.  The  goggles  should  be  evaluated  to  ensure  adequate  eye
protection  for  the  user under all possible exposure positions  and uses.  The location  of
controls,  particularly  the  radiation  emission control,  should be convenient  for  the  user
to  reach in case of emergency.  The contents  and locations  of the required  labels should
be  carefully  reviewed  to  assure  they  comply  with  the  standard  and  policies.  The
development  of a recommended exposure schedule for the particular  product  design is of
utmost  importance  and should be checked against the  agency guidelines.  In general,  an
adequate safety  factor  regarding  the use of the  product should be built  into  the product
design,  because the  product  is  not  only  expected  to  be in compliance  at  the  time  of
manufacture  but  also  during  its  entire  useful  life  (see  Appendix  B  for  details  of
compliance requirements).
Further,  the manufacturing  process must be reviewed  to assure that the design basis
for  the  product,  components,  and  packaging  is  correctly  translated  into  approved
specifications.
The  approved  design  specifications  must  be  adequately  documented.  The
manufacturing  process  must be described  in writing  and implemented  according  to  the
written  description  in order to ensure the  finished  product  is manufactured  acording  to
the  approved design.  Any changes in the  design and/or  manufacturing  process must be
reviewed,  approved, and dated before implementation.
2.2  ENGINEERING  AND PROTOTYPE TESTING AND EVALUATION
Engineering  models and prototypes  should be built  and tested  thoroughly  to  ensure
that  the  product  can  be  manufactured  as designed  and  be  in  compliance  with  the
performance standard during the product's useful life.
4 This testing  must include  adequate transportation  tests,  tests  of performance  under
expected  environmental  condidtions,  use and abuse testing,  and accelerated  life  tests.
A consistent  effort  is required  to keep drawings and prototypes  up-to-date  and accurate.
Any design changes must be properly  documented,  tested,  and evaluated  in relation  to
product  safety.
3.  COMPONENTS AND PRODUCTION TESTING
3.1  COMPONENT EVALUATION  AND TESTING
Components should be received,  stored,  and handled in a manner to  prevent  damage,
mixup,  contamination,  and  other  adverse  consequences.  Components  should  be  in-
spected,  sampled, and tested  for  conformance  to specifications  because certain  compo-
nents  can  affect  the  compliance  of  ultraviolet  lamps  and/or  sunlamp products.  For
example:, glass  structure  or  an electrical  or  mechanical  component,  such  as timer,
eyewear,  or emission control,  will  definitely  affect  the product's  compliance.  (Tags and
labels are also important  for  compliance.)
Whether  such components  are  fabricated  by  the  manufacturer  of  the  ultraviolet
sunlamp  or  sunlamp product,  or  purchased  from  a  vendor,  proper  evaluation  of  the
components is essential  in determining  if  the  ultraviolet  or sunlamp product  will  comply
with  the applicable  standard  after  manufacture.  Manufacturers  who obtain  components
from  different  vendors  may choose to  rely  on a supplier's  certificate  of  analysis  and
approval  in lieu  of  component testing.  These certificates  should be made part  of  the
quality  assurance documentation.
However,  the  responsibility  for  product  compliance  rests  with  the  manufacturer  of
the  final  product  rather  than  with  the  supplier  of components  or material.  Therefore,
any decision to totally  rely  on a supplier's  evaluation  must be carefully  considered; some
type  of  incoming  acceptance  examination  or  testing  is recommended.  An  exception
applies to the lamp manufacturers'  certification  of compliance  for  their  UV lamps.  This
certification  is acceptable  because the  lamp  manufacturers  are  legally  liable  for  the
validity  of that certification.
In general,  three  points  must be considered  in evaluating  components  prior  to  their
use in the ultraviolet  lamp or sunlamp product.
1.  Performance  specification  for  components  should  be  developed,  taking  into
consideration  both the requirements  of the performance  standard and a tolerance
analysis  of  the  product.  A  tolerance  analysis  is  a  calculation  of  a  product's
performance  range that  can result  from  component variations.  Such an analysis
would,  whenever possible, be experimentally  validated.
2.  All  components  should be tested  to  verify  that  their  performance  is  within  the
range  of  specifications  required  of  them  by  the  manufacturer  of  the  final
product.  Switches  and timers  may need to  undergo accelerated  life  testing  to
ensure reliability.  Durability  and ruggedness of, such components  may be appro-
priately  tested  under expected  environmental  conditons.  Components  also  may
be appropriately  tested  after  assembly of a subsystem or entire  product.
3.  If  at any time  the design specifications  or materials  of a component are changed,
the  design of the  entire  product  should be reviewed  to  ensure that  the  change
does not  in any way affect  the compliance  of the  product  with  the  performance
standard.
5 f;;
3.2  PRODUCTIONT ESTING
In  designing  the  production  quality  assurance  and  testing  program,  it  is  first
necessary to  identify  the  parameters  that  need to  be examined  or tested  in  order  to
determine  compliance  with  the  performance  standard.  The  identification  and critical
nature  of  these  parameters  depend to  a large  extent  upon the  design,  function,  and
anticipated  use  of  a  specific  product.  Some examples  of  such parameters  are  the
irradiance  ratio,  reliability  of timers  and switches,  the  inclusion and durability  of labels,
mechanical  construction,  electrical  safety,  and so forth.  Some examinations  or tests
may  consist  of  simple  inspections.  For  example,  the  product  should be inspected  to
determine  that  all  labels  are  in  the  correct  positions  and  properly  attached  to  the
product.  However,  other  tests,  such as those  involving  the  irradiance  ratio  of  the
ultraviolet  lamp  or sunlamp product  and the  spectral  transmittance  of  the  protective
eyewear,  are  more  complicated  and  require  design  of  test  methods  and the  use  of
defensible  measurement instrumentation  and techniques.
Testing  will  be of two types:  qualitative  and quantitative.  Qualitative  testing  refers
to a functional  test  of performance  features  and inspections,  such as tests  that  confirm
the  inclusion  of  labels  or  instructional  material.  Quantitative  testing  refers  to  the
measurement  of  variable  parameters  such as the  spectral  irradiance  of the  ultraviolet
lamp.  Individual  tests  may be designed for  each parameter.
Rejection  or  acceptance  criteria  need to  be determined  for  different  tests.  In
qualitative  tests,  it  is easy to  establish the criteria  because one is faced  with a "has" or
"has not"  or "functions"  or "does not function"  situation.  The establishment  of rejection
or acceptance  criteria  for  the  quantitative  test  is more involved.  An example  is the
measurement  of  ultraviolet  radiation  from  an  ultraviolet  la~p.  The  rejection  or
acceptance  criteria  must assure the  manufacturer  that  ultraviolet  radiation  is  within
the  irradiance  ratio  limits  for  sunlamp products  as specified  in the  sunlamp products
performance  standard,  even  when the  total  measurement  uncertainty  is  taken  into
account.  If  the  testing  is  not done on every unit,  it  may be necessary to  have  more
stringent  criteria  than if every unit were tested.
3.3  QUALITATIVE  TESTING
{
Qualitative  testing  should  be conducted  on  all  of  the  units  produced  and  should
include checks or testing  of the following:
the  presence, secure attachment,  and proper  content  of a label certifying  com-
pliance  of the product;
2.  the  presence, secure attachment,  and proper content  of the  label  that  identifies
the  manufacturer  and place and date of manufacture;
3.  in the  case  of  ultraviolet  lamps,  the  presence,  secure  attachment,  and  proper
content  of the warning label;
4.  in the  case of  sunlamp products,  the  presence,  secure  attachment,  and proper
content  of all hazard warning labels;
5.  the presence and proper content  of instructions  to the users;
6.  the presence and proper function  of the timer;
6
1.  7.  the presence and proper functioning of a control  that permits users to  manually
terminate  radiation  emisssion  from  the  sunlamp  product  at  any time  without
disconnecting the electrical plug or removing the ultraviolet lamp;
the  presence and required  number of protective  eyewear devices  accompanying
the sunlamp product;
9.  the proper functioning  of the ultraviolet  lamps; and
10.  the presence and proper contents  of  user instructions  for  both ultraviolet  lamps
and sunlamp products.
3.4  QUANTITATIVE  TESTING
Quantitative  testing  includes the following  types of tests:
1.  measurement  of  ultraviolet  radiation  output  to  determine  if  the  spectral  irra-
diance  is  within  the  expected  range  for  the  product  and  its  recommended
exposure schedule;
2.  measurement of the  irradiance  output  within  the specified  wavelength  ranges to
determine  the irradiance  ratio;
3.  measurements of protective  eyewear spectral  transmittance,  to determine  that  it
does not exceed the values required  by the performance  standard; and
4.  measurement  of  timer  acuracy  to  determine  that  the  error  is  not  greater  than
fIG  percent  of the  maximum timer  interval.
There are  many ways to  conduct these measurements.  CDRH does not object  to  any
method  that  would,  when correctly  executed,  yield  the  correct  physical  values.  Pro-
cedures for compliance  testing  at FDA's Winchester laboratory  are provided  in Appendix
Bex pfoors urme asncuhfeadcutulere arsre'  prreofveirdeendc ei n oAnplpy.e ndiPxr oCc. edures  for  developing  the  recom. mended
3.5  TEST CONDITIONS FOR DETERMINATION  OF COMPLIANCE
In order  for  the  product  to  have a valid  certification  (21  CFR 1010.2), the  test  on
which the certificaton  is based must meet the following  conditions:
1.  The tests  for  the  irradiance  ratio  and to  develop  and verify  the  recommended
exposure  schedule  (and/or  to  establish  lamp  compatability)  and  protective
eyewear  transmittance  must account  for  all  measurement errors  and statistical
uncertainties  in the  measurement process and, wherever  applicable,  for  changes
in radiation  emission or degradation  in radiation  safety  with age of the product.
The  measurements  to  check  irradiance  ratio,  recommended  exposure  (and/or
lamp  compatability)  and protective  eyewear transmittance  must be made under
the operational  conditions  of lamp voltage,  current,  and user position  as recom-
mended by the  manufacturers.  The measuring instrument  must be positioned  at
the recommended  exposure position  orientation  and so oriented  as to  detect  the
maximum amount of radiation  detectable  by the instrument.
7
82..   3. The timepiece  used to  determine  timer  accuracy  is accurate  and reliable. It  is
regularly  calibrated.
4.  It  must provide  procedures to check  for  all items  mentioned  in 3.3 and must also
provide  for checksheets to include date, initials  of tester,  and product  identifying
marks.
3.6  SAMPLING,  AUDIT  AND RECYCLING
3.6.1 Sampling
CDRH  recommends  testing  100 percent  of  the  products  to  determine  compliance.
However,  in the case of products  built  in large  quantity  on a production  line,  a sampling
plan that  randomly  allows selection  of some units  for some tests  and inspections  may be
appropriate.  When this  is  done,  it  is  the  responsibility  of  the  manufacturer  to
demonstrate  that  the  sampling  plan  will  ensure compliance  of  the  product  with  the
standard  and with  the  design specifications.  A random sampling  scheme must be truly
random,  i.e.,  the  probability  of a unit  being selected  is the same for  all produced units.
The so-called  "random"  selection  of units  from  a production  line  based on a judgment of
randomness by an individual  does not constitute  true  random sampling.  A scheme that  is
based on generating  random numbers or  other  specified  statistical  schemes is a more
objective  basis for  random sampling.  Examples of  sampling plans are contained  in Mil-
Std-105D and Mil-Std-414  (See References 1 and 2).
In addition  to  random sampling to test  for compliance,  any systematic  problem areas
may warrant  testing;  e.g.,  at the  beginning of a production  run,  or at the  beginning of
each day, or when a new assembler begins work on a product,  and so forth.
3.6.2  Product Audit
A product  audit  is a GMP requirement.  It  is desirable  to  establish  such an audit  to
test  the  validity  of the  quality  control  and testing  program.  A product  audit  includes
testing  previously  tested  and accepted  products  to  provide  a check  on the  measuremnt
process and the acceptance procedures.  A specific  sampling procedure should be used to
select  accepted  units  that  should be subjected  to  all  the  tests  and inspections  of  the
product  quality  assurance  program.  Repeated  failures  of  audited  samples  indicate
problems  in the  product  design or the  quality  assurance program,  which  must be traced
and corrected.
3.6.3  Recycling
Units  or  lots  that  fail  to  conform  to  specifications  and  which  are  refurbished,
repaired,  reworked,  and so forth  must be subjected  to  the  testing  and scrutiny  and the
same  acceptance  or  rejection  criteria  to  which  the  original  was subjected  for  the
characteristics  that  may be adversely affected  by the reprocessing.
8 REFERENCES
1.  United  States  Department  of  Defense.  Sampling Procedures and Tables  for
Inspection  by Attributes.  Military  Standard 105D (April  27, 1963).
United  States  Department  of  Defense.  Sampling  Procedures and Tables  for
Inspection  by Variables  for  Percent  Defective.  Military  Standard  414 (June  11,
1957).
Copies of these documents (Mil-Std  105D and Mil-Std  414) are for sale by
Superintendent  of Documents
U.S. Government Printing  Office
Washington, D.C.  20402
9
2.   APPENDIX A
DESIGN CONSIDERATIONS FOR COMPLIANCE  WITH THE SUNLAMP STANDARD
A.  FOR ULTRAVIOLET LAMPS
1.  Each ultraviolet  lamp,  unless exempted,  must have on 1:he product  a permanent
label  which  contains  (21  CFR  1040.20(d)(2 (i)  the  words  "Sunlamp-DANGER-
UltJ:,aviolet radiation.  Follow  instructions,"  (ii) the  model identification  and (iii)
the words "Use ONLY  in fixture  equipped with a timer."
2.  Each ultraviolet  lamp  must be permanently  labeled  or marked  in such a  manner
that  the  name  of  the  manufacturer  and  month and year of  manufacture  (all  of
which  may  be  expressed  in  code)  can  be  determined  (21  CFR  1040.20(d)(3.
Labels or marks shall be legible  throughout  the useful life  of the lamp.
3.  When a  lamp  is  sold  separately  from  a  sunlamp product,  the  lamp  packaging
uniquely  associated  with  an  ultraviolet  lamp  (i.e.,  innermost  lamp  packaging)
m\l~;t bear  a  label  or  tag  that  contains  the  full  name  and  address  of  the
manufacturer,  place of manufacture  and month and year of manufacture  if  such a
label  or tag  is not affixed  or inscribed  on the  lamp  itself  (21  CFR  1040.20(d)(3)
and  21  CFR  1010.3(a.  If  the  lamp  is  sold  under  a  name  other  than  the
manufacturer,  the  full  name and address of the  company under whose name the
lamp  is sold  may be  set forth,  provided  sufficient  information  is  furnished  to
CDRH  to  allow  the  Agency to  identify  the  manufacturer.  The place  of  manu-
facture  may be expressed in code.  However,  no specific  place  of  manufacture
identification  will  be required  if  the  place  of  manufacture  is the  same as the
address of the  manufacturer  stated  on the label,  or if the  manufacturer  has only
one place  of  manufacture  for  such lamps and has identified  that  place  of  manu-
facture  to CDRH.  The month and year of manufacture  must appear in full,  with-
out  abbreviation,  as in the  following  example  -Manufactured:  December  1998.
Ho1wever, when the date  of  manufacture  is provided  in code on the lamp,  CDRH
will  not object to the omission of the date of manufacture  on the packaging if the
ke~r to  the date  code and the  location  of the  coded information  are provided  on
the  packaging  in a manner that  will  allow  the  date  to  be readily  decoded.  The
month and year of manufacture  on the packaging  must be the same as that  which
appears on tne lamp.
t
4.  Thl~ lamp  packaging  uniquely  associated  with  the  ulraviolet  lamp  not  accom-
panying  a  sunlamp  product  must  also  bear  a  label  or  tag  which  contains  a
statement  by the  manufacturer  certifying  that  the  lamp conforms  to the require-
ments of  the  Federal  performance  standard  for  such lamps  if  the  certification
label  or tag  is not affixed  or inscribed  on the  lamp itself  (21 CFR  1040.20(d)(3)
and  21  CFR  1010.2(b.  The  certification  statement  can  be  in  any  of  the
following  acceptable  formsc
"Product  complies  with  DHHS  radiation  performance  standard,  21  CFR
1040.20"
"Product  complies  with  DHHS  radiation  performance  standards,  21  CFR
Chapter 1, Subchapter J"
11 "Product  complies  with  applicable  DHHS  standards  under  the  Radiation
Contirol for  Health and Safety Act  of 1968."
Other  certification  statements  may  be  used  as  long  as  they  are  clear  and
unambiguous.
5.  The  ratio  of  the  irradiance  within  the  wavelength  range  of  greater  than  200
nanometers  through  260  nanometers  to  the  irradiance  within  the  wavelength
range  of  greater  than 260 nanometers  through  320 nanometers  must not exceed
0.003 at any distance  and direction  from  the lamp (21 CFR 1040.20(c)(1.
6.  The  lamp  must not be capable of  insertion  and operation  in the  "single-contact
medium  screw"  and/or  "double-contact  medium  screw"  lampholders  (21  CFR
1040.20(c)6).
7.  Instructions  containing  information  as required  by 21  CFR  1040.20(f)  must  be
provided  to the purchasers of the lamp not accompanying a sunlamp product.
8.  A  clear  identification  by brand  and  model  designation  of  all  lamp  models  for
which  the  lamp  manufacturer  claims  equivalency  (see  CDRH  policy  on  lamp
compatability  dated September 2, 1986).
B.  FORS  UNLAMPP RODUCTS
1.  Each sunlamp product  must have a label that contains the  information  as required
by  21  CFR  1040.20(d)(1)(i)  through  (vi),  including  the  warning  statement,
designation  of  the  ultraviolet  lamp  type  which  is  to  be  used  in  the  product,
instructions  concerning  minimum  use distance,  recommended exposure schedule,
and a statement  of the time  it  may take before the expected results appear.  The
design  must  clearly  define  the  contents  and locations  of  the  labels  required  in
Section  1040.20(d), and their  permanence  and  visibility  must be assured.  See
CDRH  policy  statement  on  warning  label  dated  June  25,  1985,  and  policy
statement  on "Maximum  timer  interval  and exposure schedule" (Appendix C).
2.  Each sunlamp product  must bear a label  or tag  that  contains  the  full  name and
address  of  the  manufacturer,  place  of  manufacture  and  month  and  year  of
manufacture  (21 CFR  1040.20(d) and 21 CFR 1010.30(a.  If  the  sunlamp product
is sold under a name other  than the  manufacturer,  the  full  name and address of
the  company  under whose name the  product  is sold  may be set forth,  provided
sufficient  information  is furnished  to  CDRH to  allow the  Agency to  identify  the
manufacturer.  The place of manufacture  may be expressed in code.
However,  no specific  place  of  manufacture  identification  will  be required  if  the
place  of  manufacture  is the  same as the  address of the  manufacturer  stated  on
the  label  or  if  the  manufacturer  has  only  one place  of  manufacture  for  such
products  and has identified  that  place  of manufacture  to  CDRH.  The month and
year of manufacture  must appear in full,  without  abbreviation,  as in the following
example -Manufactured  December 1998.
3.  Each sunlamp product  must also bear a label  or tag  which contains  a statement
by the  manufacturer  certifying  that  the  product conforms  to the requirements  of
the  Federal  performance  standard  for  such products (21 CFR  1040.20(d) and 21
12 CFR  lOlO.2(b. The  certification  statement  can  be  in  any  of  the  following
acceptable forms:
"Product  complies  with  DHHS  radiation  performance  standard,  21  CFR
1040.20"
"Product  complies  with  DHHS  radiation  performance  standards,  21  CFR
Chapter  1, Subchapter J"
"Product  complies  with  applicable  DHHS  standards  under  the  Radiation
Control  for  Health and Safety Act  of 1968."
Other  certification  statements  may  be  used  as  long  as  they  are  clear  and
unambiguous.
4.- The  ratio  of  the  irradiance  within  the  wavelength  range  of  greater  than  200
nanometers  through  260  nanometers  to  the  irradiance  within  the  wavelength
range  of  greater  than 260 nanometers  through  320 nanometers  shall  not exceed
0.003 at  any distance  and direction  from  the  product (21 CPR 1040.20(c)(1.  In
meeting  this  requirement,  a  manufacturer  of  sunlamp products  may  rely  on a
certification  of compliance  made by the  manufacturer  of the ultraviolet  lamp.
5.  A  sunlamp  product  must  incorporate  a  timer  with  multiple  timer  settings
adequate  for  the  recommended  exposure time  intervals  for  different  exposure
distances  and expected  results  of the  product  as specified  on the  product  label.
The  maximum  timer  interval  shall  not  exceed  the  recommended  maximum
exposure time.  The timer  must have an accuracy of :t.l0 percent  of the  maximum
timer  interval.
6.  A  sunlamp  product  must incorporate  a  control  to  enable the  user to  manually
terminate  radiation  emission  from  the  sunlamp  product  at  any time,  without
disconnecting  the electrical  plug or removing  the UV lamps.
7.  The  timer  may not  automatically  reset  and restart  the  sunlamp  product  for  a
period  greater  than  the  unused portion  of  the  timer  cycle,  when emission  was
terminated.
8.  The spectral  transmittance  of the protective  eyewear  must not exceed a value  of
0.001  over  the  wavelength  range  of  greater  than  200 nanometers  through  320
nanometers  and a value  of  0.01 over the  wavelength  range  of  greater  than  320
nanometers  through 400 nanometers, and must be sufficient  over the wavelengths
greater  than 400 nanometers to enable the user to see clearly  enough to read the
labels  and  reset  the  timer.  There  is  protective  eyewear  on the  market  that
appears to  comply  with  this  requirement.  The  sunlamp  product  manufacturer
could  require  a certification  by the  protective  eyewear  manufacturer  that  the
product complies  with the applicable  portion  of the standard.
9.  Instructions  containing  all the  information  required  by 21 CFR  1040.20(f)(1) must
be provided  to the purchasers of the product.
13  APPENDIX  B
FOOD AND DRUG ADMINISTRATION
WINCHESTER ENGINEERING  AND ANALYTICAL  CENTER
PROCEDURES FOR LABORATORY  COMPLIANCE  TESTING
OF SUNLAMP PRODUCTS AND ULTRA VIOLET LAMPS
INTENDED TO BE USED IN SUNLAMP PRODUCTS
FEBRUARY,  1981
INTRODUCTION
The purpose of  this  document  is to  establish procedures  for  laboratory  compliance
testing  of  Sunlamp Products  and  Ultraviolet  Lamps  intended  to  be used  in  Sunlamp
Products  that  are  certified  by the  manufacturer  as in compliance  with  the  "Sunlamp
Products:  Performance  Standard"  published  in  21  CFR  Parts  1010 and  1040.  The
procedures  described  in  this  document  are  applicable  to  any  ultraviolet  lamp  and
product  containing  such lamps intended for  irradiation  of  any part  of the  human body by
light  (of wavelength  in air less than 320 nanometers) to induce skin tanning.  Definitions
of  terms  used in this  document  are  identical  to  definitions  published  in 21 CFR  Parts
1000 through  1040.
*SPECIAL INSTRUCTIONS*
PERFORM ALL OPERATIONS WITH EXTREME CARE.  ULTRAVIOLET  RADIATION,
OZONE AND ELECTRICAL  SHOCK ARE ALL  HAZARDS
INHERENT WITH THESE TESTS.
GENERAL INSTRUCTIONS
1.  Laboratory  control  of sunlamp products and ultraviolet  lamps intended  to  be used in
sunlamp products shall be maintained  as specified  in the  FDA Regulatory  Procedures
Manual,  the  Analyst  Guidance  Manual,  and  Compliance  Program  7390.804E
"Compliance  Testing of Sunlamp Products at WEAC."
2.  Upon notification  of  assignment of a Sunlamp/Ultraviolet  Lamp sample for  analysis,
the  analyst  shall arrange  with  the  Sample Custodian  to  transfer  the  sample to  the
test ing labora tory.
3.  All  test  data  shall  be  recorded  on  Analyst  Worksheets  (FD-431  and  FD-431a)  and
appropriate  special  data  sheets.
4.  The  sample  number  shall  be acquired  from  the  "Official  Seal"  (FD-414a)  on  the
sample and verified  with  the  "Collection  Report"  (FD-464) and be clearly  printed  on
all  worksheets.  If  no  "Official  Seal"  is  present  on  the  sample,  consult  your
supervisor.
5.  Before  breaking  the  seal  and  removing  the  sample  from  its  shipping  carton,  the
analyst shall initiate  an Analyst  Worksheet (FD-431) in accordance  with  Chapter 9 of
the Analyst  Operations  Manual.
15 6.  All  accompanying  materials  shall  be  read  and  understood  before  any  testing
procedures  are  initiated.  Consult  your  supervisor  if  any problems  are  encountered
with  the materials.
COMPLIANCE TESTING
I. Introduction
The  compliance  tests  delineated  in this  part  are  performend  on all  Sunlamps and
Sunlamp  Products  collected  for  analysis  at  WEAC  under  compliance  program
7390.804E.
II.  SunlampP  roducts
A. Performance
1 Measurement of lrradiance  Ratio  Limit,  Timer  Accuracy,  and Transmission of
Protective  Eyewear shall be carried  out according  to  the procedures outlined
in Appendices A through C [of this Appendix]  respectively.
2.  Radiation EmissionC  ontrols
a.  Verify  that  there  is  a  user  control  on  the  sunlamp  product  that  will
terminate  radiation  emission at  any time  without  disconnecting  the  elec-
trical  plug or removing the ultraviolet  lamp.
b.  Verify  that  when  radiation  emission  from  a  sunlamp  product  has  been
terminated  for  any reason,  including  termination  by a timer,  the  product
will  not automatically  recycle  and restart.
B.  Labels
1.  Identification  Labeling
a.  Visually  examine the  identification  label  for  (a) presence, (b) permanence,
(c) legibility,  (d) accessibility,  and (e) correctness.
b.  Record  the  name  of  the  manufacturer  and  the  month  and  year  of
manufacture.
2.  Certificaton  Labeling
a.  Visually  examine the  certification  label  for  (a) presence,  (b) permanence,
(c) legibility,  (d) accessibility,  and (e) correctness.
3.  Verify  that  the following  statement  is present on the product  warning label:
a.  "DANGER--Ultraviolet  radiation.  Follow  instructions.  A void  over-
exposure.  As  with  natural  sunlight,  overexposure  can cause eye and skin
injury  and allergic  reactions.  Repeated  exposure  may cause premature
aging  of  the  skin  and  skin  cancer.  WEAR  PROTECTIVE  EYEWEAR;
16 FAILURE TO MAY  RESULT IN SEVERE BURNS OR LONG-TERM  INJURY
TO THE EYES.  Medications  or cosmetics  may increase your sensitivity  to
the  ultraviolet  radiation.  Consult  physician  before  using  sunlamp if  you
are  using  medications  or  have  a  history  of  skin  problems  or  believe
yourself  especially  sensitive  to sunlight.  If  you do not  tan  in the sun, you
are unlikely  to tan from the use of this product."
Verify  that  the  following  recommendations,  directions,  warnings,  and state-
ments are present on the product  warning label:
b.  A recommended exposure position  (may be expressed in distance  or though
the use of markings or other means, i.e.,  product design).
c.  A warning  that  exposure at distances  less than the  minimum  use distance
is not recommended.
d.  A recommendede xposures chedule that complies with CDRH policy state-
ment dated August 21, 1986.
e.  A statement of the time it  may take before the expected results appear.
f.  Designation of the ultraviolet  lamp type  which is to be used in the product.
C. Instructions
Verify that the users' instructions contain the following:
1., A reproduction  (color  optional)  of the  label described  in 3 above, prominently
displayed  at the beginning of the instructions.
2.  A  statement  of the  maximum  number of people who  may be exposed to  the
product  at the same time  and a warning  that  only  that  number  of protective
eyewear has been provided.
Instructions for obtaining repairs and recommended replacement components
and accessories which are compatible  with  the product,  including  compatible
eyewear,  ultraviolet  lamps, timers,  reflectors,  and filters,  and which will,  if
followed,  result  in continued compliance  with  the Standard.
III. Ultraviolet  Lamps
A.  Performance
.". 1.  Measurement  of Irradiance  Ratio  Limit  shall be carried  out according  to  the
..
procedures outlined  in Appendix A [of this appendix].
2.  Compatability of Lamps
a.  Determine  visually,  by physical  measurement, or  trial  that  the  lamp
cannot  be  inserted  into  either  a  "Single-contact  medium  screw"  or
"Double-contact mediums crew" lampholder.
b.  For lamps  claiming  "equivalency"  to  other  lamps,  conduct  the  testing  as
specified  in our policy statements  of August 21 and September 2, 1986.
17
3.  B.  Labels
1.  Identification  Labeling
a.  Visually  examine the  identification  label  for  (a) presence, (b) permanence,
(c) legibility,  (d) accessibility,  and (e) correctness.
b.  Record the name of the  manufacturer  and the  month and year,  or codes, of
manufacture  as  marked  on  the  inscribing  tags,  or  labels,  or  on  the
packaging.
2.  Certification  Labeling
a.  Visually  examine  the  certification  label  as required  under 1010.2 for:  (a)
presence,  (b)  permanence,  (c)  legibility,  (d)  accessibility,  and  (e)
correctness.
3.  Other Labeling
Determine  the presence of labels on the lamp stating:
a.  "Sunlamp-DANGER-Ultraviolet radiation.  Follow instructions."
b.  The model identification
c.  "Use ONLY in fixture  equipped with a timer."
4.  If  the labeling  in 1 and 2 above is not permanently  affixed  or inscribed  on the
lamp  but  is  on  the  lamp  packaging,  determine  that  the  name  of  the
manufacturer  and month and year are permanently  affixed  or inscribed  on the
exterior  surface  of  the  ultraviolet  lamp  so  as  to  be  legible  and  readily
accessible  to  view.  The name of  the  manufacturer  and  month and year  of
manufacture  required  to  be permanently  affixed  or inscribed  on the  exterior
surface  of the  lamp may be expressed in code or symbols.
C. Instructions
Verify  that  the users' instructions  contain the following:
1.  A reproduction  (color  optional)  of the  label  required  in 3 above, prominently
displayed  at the  beginning of the instructions.
2.  A warning  statement  with the words "DANGER--Ultraviolet  radiation.  Follow
instructions.  A void overexposure.  As with  natural  sunlight,  overexposure  can
cause eye  and  skin  injury  and allergic  reactions.  Repeated  exposure  may
cause premature  aging  of  the  skin  and  skin  cancer.  WEAR  PROTECTIVE
EYEWEAR;  FAILURE TO MAY RESULT IN SEVERE BURNS OR LONG-TERM
INJURY  TO  THE  EYES.  Medications  or  cosmetics  may  increase  your
sensitivity  to  the  ultraviolet  radiation.  Consult  physician  before  using
sunlamp if  you are  using medications  or have a history  of  skin problems  or
believe  yourself  especially  sensitive  to sunlight.  If  you do not tan in the sun,
you are unlikely  to tan from the use of this product."
3.  A  warning  that  the  instructions  accompanying  the  sunlamp  product  should
always be followed  to avoid or to minimize  personal injury.
18 4.  ,A~c lear  identification  by brand and complete  model  designation  of  all  lamp
models for  which the lamp manufacturer  claims equivalency.
APPENDIX  A
TEST PROCEDURE FOR MEASUREMENT OF IRRADIANCE  RATIO  LIMIT
USING THE
OPTRONICS 747 SPECTRORADIOMETER
AND
HP 9825 SYSTEM CONTROLLER
I. Initial  Start-Up
A.  Spectroradiometer Switch On
1.  Switch on the  Power console (the unmarked chassis below the calculator).
2.  Switch  on the  Control  console.  Verify  that  the  pre-amp  light  below the  PM
housing on monochronometer  is on.  Shutter the PM tube.
3.  Switch on the Pacific  Photometric Instruments, push the "reset" and set the
control to ~,  verify that the PM housing fan is operating.
4.  Set the following "switches" to the ~  position: "Filter  wheel", A.Y!Q;" Pbs
c,ooler", ill;  "Responset ime", .QA;" Jog", normal; "Sphere position", ill.
5.  "JR.angingm" anual, use pushbuttonst o set to the XIO-O range.
6.  S,ets witches for "DC gain", "PMT," "Chopper," ill.
7.  "'Wavelength," ;.!QQ.
8.  Continue  with  B while the system warms up for 90 minutes.
B.  SystE!ffi Controller  Switch On
1.  Remove any dust covers, especially  from t.he HP 9872A Plotter.
2.  Place the 6940B Multiprogrammer in ~  mode then switch on.
3.  4880 Coupler Ql,t he "SRQ" Inhibit  switch should be Q.Y!..
4.  Turn  on the 3455 DVM,  3495A Scanner, 9872A Plotter,  9866B Printer  and the
9825 Calculator.
5.  Turn on the two  Kepco JQE power supplies, Kepco BHK (AC only, DC off)  and
the Sorenson ACR 3000.
6.  S'witch the Oriel  C73-14 on.
19
,;jj II.  Set-Up
Set  747 signal  to  -0.001  to  0.001  (X10-0  range) using Zero  Offset  and  manual
range change.
B.  Set the high voltage to 8.000 (800 volts).
C.  Adjust  the Zero potentiometer  on the  pre-amp housing to null  out dark current  on
the  10-4 range.
D.  Set to A.Y1Qra nge.
E.  Verify  that  the 3-in.  integrating  sphere is in place  with  the aperture  towards  the
reference  lamp.
F.  Verify  that  the  proper slits  are  in place,  normally  they  are 1  nm entrance  and
exit  and 2 nm middle.
1.  Turn HeNe  laser on.
2. .Check  laser alignment  on optical  bench.
3.  Check that  laser is centered  on aperture  plug and that  aperture  is normal  to
laser beam.
4.  Remove aperture plug.
Ill.  Wavelength Check
A.  Enter erase a on the 9825 and press "Execute".  Insert tape #14 and press "Load"
and "Execute".  Enter ~  and press "Execute".  Place the sunlamp overlay over
the special function keys. Press "clr 704".
B.  Switch the 6940 Multiprogrammer  to Remote, press "shut down" on the 9825.
C.  Set the  wavelength  to  631.9, select iQ.g mode, .1 nm jog interval  and 20 nm/sec
scan speed.
D.  Press "Run"  on the  calculator,  respond to  displayed  prompts.  If  no  answer  is
appropriate  or for no, press "Continue"  without  any entry.  Start  wavelength  632,
stop 634.
E.  Follow program prompts.
F.  Turn laser off.
G.  Place the Hg lamp attached  to the Oriel  C73-14 at the aperture.  CAUTION:  The
lamp housing is hot and the lamp is producing UV.
H.  Repeat A through C using:
1.  Set 251.9, start 252, stop 254.
2.  Set 311.9, start 312, stop 314.
20
A.  3.  Set 363.9, start 364, stop 366.
4.  Set 434.9, start 435, stop 437.
5.  Set 544.9, start 545, stop 547.
I. Turn off  C73-14 and remOVe lamp from aperture.
J.  Complete  the wavelength  calibration  chart.  If  the  mean deviation  is greater  than
:t.5  nm,  make  wavelength  drive  adjustments  as  described  in  the  Model  747
instruction  manual.
IV. Calibration Check
A.  Place  the  alignment  jig  in the  standard  lamp  bi-pin  socket.  Turn  laser  on and
verify  or establish  socket  alignment  so that  the  beam is centered  and normal  to
the plane of the bi-pin.  Turn the laser off.
B.  Establish  50 cm.  distance  from  sphere aperture  to  the  alignment  jig  using the
50-cm reference  gauge.
C.  Set the la-turn  potentiometer located above the plotter to between 4 and 6.
D.  Set the radiometer  to 199.9 nm, l-!lm  jog interval,  and 50 nm/sec scan speed.
E.  Place  working  standard  in the  socket,  place  baffles  and shields to  reduce  stray
light  on the radiometer.
F.  Press "Run" on the calculator.  Respondt o displayed prompts.  Start wavelength
200, end 400, current 7.9
G.  After  15 minutes  adjust the  potentiometer  so that  the  DVM reading  is between
0.7899219 and 0.7899999 and press "Continue".
H.  Compare  luminous  intensity  values  at 250, 270, 300, 350, and 400 nm  with  the
working standard values.  If  they differ  by more than 4 percent,  a new calibration
factor  will  have to be determined  using a standard lamp.
V.  SunlampT  est
A.  Perform  erase a "Execute"  on the  9825,  insert  tape  #13 and press "Load"  and
"Execute",  enter !.Qk1 and press "Execute".
B.  Set  up the  sample  at  the  specified  minimum  use distance  from  the  detector
aperture,  measuring  the  distance  as described  in  the  sunlamp  manufacturer's
instructions.  Gauge rods are available  for  the  most common distances.  Another
distance  may  be  used; however,  it  must  be  no  less  than  the  manufacturer's
minimum use distance.
C.  Lock the  timer  on.  Arrange  baffles  to reduce  stray  light.  Check that  the  lamp
switch  is off  and plug the  120v sunlamp into the Sorenson supply.
,~
.i D.  Press "Run"  on the calculator,  answer the display prompts.  Turn the  lamp switch
on and adjust the variac  to  130v using the DVM.
I
21 E.  After  5 minutes,  or the  manufacturer's  recommended  warm-up  time,  check  and
adjust the variac  as necessary and press "Continue".
F.  At  the  end of the data run, respond to  the  prompts.  If  plotting  is desired  make
sure there  is paper in place on the plotter.
APPENDIX  B
TEST PROCEDURE FOR
SUNLAMP TIMER ACCURACY
1.  Determine maximum timer interval
2.  Compute  maximum allowable  timer  error (fIG  percent of maximum  interval)
3.  Test accuracy  of timer  at maximum interval
a.  Set timer to its maximum
b.  Simultaneously start timer and suitable timing device (stopwatch, clock, etc).
c.  When  interval  is complete,  compute  difference  between  sunlamp  timer  setting
and measured  length  of time.
d.  Compare  timer  error  with  maximum  allowed  error  to  determine  compliance
status.
e.  Repeat steps a-d.
4.  Test accuracy of  timer  at the 1 minute setting.
a.  Perform  steps 3a-3e above using a setting  of  1 minute  instead  of the  maximum
interval  setting.  If  there  is no setting  for  1 minute,  use the  available  setting
closest to 1 minute.
5.  Test accuracy  of the  timer  at the  minimum marked setting,  provided  it  is different
from .the setting  used in step 4 above.
a.  Perform  steps 3a-3e above, using the  minimum  marked timer  setting  instead of
the  maximum interval  setting.
APPENDIX C
TEST PROCEDURE FOR
EVALUATION  OF PROTECTIVE EYEWEAR
This test  is to be performed  using a Carey Model 118 Spectrophotometer.
22 1.  Initial  set-up control settings:
"Powl~r" switch QN.
"Func~tion"s witch ~
"Mode" switch ~
"Source Select" switch y!
"VV Source" switch ~
"VIS Source" switch !llilli
Open the  sample  compartment  and remove  both  cell  holders.  Place  the  universal
positioning  jig  in the sample chamber.  Clamp the protective  eyewear to  be tested
in thE~c lip and adjust the base and arm so that  one lens intercepts  the  sample beam
about halfway  across the chamber.  The sample beam is a thin  vertical  green  light
in the  front  of the  chamber.  The lens should face  left  so the  beam is incident  on
the front.  Orient  the lens so that  it is perpendicular  to the beam and intercepts  the
entirE~ beam.  A piece  of white  paper will  help to  locate  the  beam and to  ensure
that  the  entire  beam  is  intercepted.  Make  sure  no  part  of  the  eyewear  or
positioning  jig  intercepts  any  of  the  reference  beam  that  also  runs  across  the
chamber.  Close the chamber and turn "Source Select"  switch Q.:!::l.
3.  Set the "Source Select" switch to !:[Y and the "UV Source" switch to~.  Note the
time to allow a 30-minute warmup of the UV lamp.
4.  Control settings for data run:
"Beam Interchange"  switch  NORMAL
"Mode"  switch  AUTO SLIT
"Period"  switch!
"Func~tion" switch ~
"Wavelength"  switch QEE
"Chart"  switch QEE
"Scan Speed" switch  2 nm/sec
,iChart Selector"  switch  50 mm/in
"Baseline"  switch  lli
"Baseline  UV-VIS" switch MY
5.  Using' the  knob on the left  side of the cabinet,  set the wavelength to 375 nm.
6.  Set the chart speed so that the pen will  start  on a line. Turn  on wavelength  and
chart drive toggle switches.
7.  Turn "Scan Switch" to "-".  Whenw  avelength reaches 200 nm, turn off.
8.  Turn off  pen and chart switches and turn "Mode" switch to ~.
9.  Open the  sample  chamber,  remove  the  universal  positioning  jig  and eyewear,  and
replace  the cell  holders.
10.  Put  E!yewear on.  Determine  if  labels  and  timer  graduations  can be re~d. Also
determine  if there  are light  leaks around the eyewear.
I
23
,'"i,i:t",.
,O'i'"
2.   APPENDIX C
POLICY  ON MAXIMUM  TIMER INTERVAL  AND EXPOSURE SCHEDULE
FOR SUNLAMP PRODUCTS
':'ji\
I1;11
~
\J
25 DEPARTNIENT  OF HEALTH  & HUMAN  SERVICES
Public Health  Service
Food and Drug Administration
Aug.  21, 1986  Rockville MD 20857
TO: ALL  MANUFACTURERS,  IMPORTERS  AND  POTENTIAL  MANUFACTURERS  OF
SUNLAMPP RODUCTS
SUBJECT: POLICY  ON MAXIMUM  TIMER  INTERVAL  AND  EXPOSURE  SCHEDULE
FOR SUNLAMPP  RODUCTS
The amended performance standard for sunlamp products (21 CFR 1040.20)w  as
published in the September 6, 1985 issue of the Federal Register and will become
effective  September 8, 1986. Any sunlamp product manufactured on or after  that date
must comply with the amended standard.
The ten (10) minute  maximum timer  interval  requirement was removed from the original
performance standard since there are newer sunlamp products on the market for which
ten (10) minutes is not appropriate.  The maximum timer  interval  now depends on the
intensity  and spectral distribution  of ultraviolet  (UV) radiation emission of each
individual  model of sunlamp product and must not exceed the maximum recommended
exposure time provided on the required product warning label.  Therefore,  sunlamp
product manufacturers  must develop an exposure schedule and establish the maximum
recommended exposure time (and therefore  the maximum timer  interval) based on the
characteristics  of their  particular  products.
The intended purposes of a sunlamp product timer are to provide for r.eliable control of
exposures and to limit  acute (and delayed) damage from unintentionally  long exposures.
However, the maximum timer  setting should also allow for selection of exposure times
needed to build up and maintain a tan.  The maximum timer  interval is in no way to be
considered as a safe limit;  all ultraviolet  radiation is potentially  hazardous.
The standard requires the manufacturer to provide an exposure schedule in the product
warning label.  The purpose of the exposure schedule is to allow a person to gradually
build-up skin pigmentation and to maintain a tan while controlling  the risk of acute
injury and delayed adverse effects.  Since the UV radiation dose that causes a barely
discernible  pink coloration  (minimal erythemal dose or MED) is not the same for
different  skin types, the exposure schedule for first  time users will depend on the skin
type of the user.  Furthermore,  suberythemogenic doses of UV radiation received at 24
hours intervals  initially  lead to lowering of the erythema and tanning thresholds.
Therefore,  the exposure schedule and maximum recommended exposure time should be
constrained by the potential  for erythema as well as the quantity  of radiation necessary
to achieve and maintain a tan.
POLICY:
The Center for Devices and Radiological Health (CDRH) will use the following criteria
to evaluate the adequacy of the exposure schedule and the recommended maximum
exposure time (and therefore  the maximum timer interval):
26
BACKGROUND: 1) The maximum recommended exposure time  (and maximum  timer  interval)  must
not exceed a value which will  result  in an exposure of four (4) times  the  minimal
erythema  dose (MED) for untanned Type II skin (always burns, then tans slightly).
This is based on the  CDRH Erythema  Action  Spectrum [proposed action  spectrum
of  Commission Internationale  de L'Eclairage  (CIE) modified  by CDRH].  See
Appendix A [of this appendix] for the  action  spectrum and weighting  factors  and
equations needed to derive  it.
The formula  for determining  the recommended maximum exposure time,  "Te"  in
seconds is:
624J/M2
T  =
e """' V.R.
L  I  I
where  Standard  MED = 156J/M2  at 296 nm
Vi = weighting  factor
Ri = irradiance  in W/M2
2) The recommended maximum exposure time  must not exceed a value which will
result  in an exposure of four (4) times  the  minimal  melanogenic dose (MMD) for
untanned Type II skin.  This is based on the melanogenic action  spectrum
developed by Parrish et ale (1982).  See Appendix 8 [of this appendix] for this
action spectrum.
The formula  for determining  the recommended maximum exposure time,  "Tm"  in
seconds is:
1836J/M2
-
T
m
where  standard  MMD  = 459J/M2  at 296 nm
Ji = weighting  factor
Ri = irradiance  in W/M2
3) The recommended exposure schedule should provide  for exposures of no more
than 0.75 MED three times the first  week, gradually  increasing the exposure the
following  weeks until  maximum tanning has occurred  (approximately  four weeks
total)  and then provide  for  maintenance  of a tan by biweekly  or weekly exposures
of up to  four (4) MEDs or four  (4) MMDs, whichever is less.
CDRH believes  that  the above criteria  balance the need to  limit  acute (and delayed)
damages from  unintentionally  long exposure and the need to provide  for single exposure
durations  adequate to achieve and maintain  a tan.
':r
i
t
Walter E. Gundaker, Director
Office  of Compliance
Center  for Devices and
Radiological  Health
Appendices
;;8
27 \~;'.1
"'"
c,'  c Appendix A
(page 1)
Weighting factors  for erythema,  Vi
-4
L
0
9
0
f -3
W
e
R -2
t
n
9
-1
F
a
c
t
0
r a
s
250 275 300 325 350 375 400
Wavelength  (nm)
The equations descritling  the curve are:
V. (;\.)=  1.0(250 < ;\.<  302 nm)
I
V.(:.\) =  10.0 114( 302-A) (302  <:.\  <  325  nm)
I
V. (;\) = 10.0161(1 59-.\.()3 25 < ;\ < 405 nm)
!
28 Appendix  B
(page 1)
Weighting factors  for  melanogenesis, Ji
1.0E +00
W
e
I
9
h  1.0E-01
t
i
n
9
F  1.0E-02
a
c
t
0
r  1.0E-03
Jj
1.0E-O4
250 300 350 400 450
Wavelength (nm)
The MMD as function  of wavelength has been interpolated  (using log MMD) from  the
action  spectrum  for  melanogenesis of Type II skin (Parrish  et ale 1982)
29 Appendix  B
(page 1)
Parrish Melanogenesis  Type II Skin  1982  Normalized  to 296 nm
Wavelen~h  Ji  Wavelen~h  Ji  Wavelen~h  Ji-
250  .378409  302  .815892  354  .100202E-02
251  .374828  303  ..750391  355  .972644E-03
252  .371428  304  .690261  356  .944186E-03
253  .366714  305  .502296  357  .916645E-03
254  .364225  306  .36551  358  .890022E-03
255  .360783  307  .265997  359  .863859E-03
256  .35734  308  .193565  360  .838613E-03
257  .353943  309  .14087  361  .813826E-03
258  .350547  310  .102497  362  .789958E-03
259  .347196  311  .745893E-01  363  .767007E-03
260  .343891  312  .054301  364  .747729E-03
261  .340632  313  .395016E-01  365  .722942E-03
262  .337419  314  ..341137E-01  366  .666943E-03
263  .334206  315  .294593E-01  367  .615075E-03
264  .331039  316  .254384E-01  368  .567338E-03
265  .327672  317  .219683E-01  369  .523272E-03
266  .327413  318  .189709E-01  370  .48288E-03
267  .326954  319  .163821E-01  371  .44547E-03
268  .326449  320  .141467E-01  372  .410953E-03
269  .32599  321  .122143E-01  373  .379097E-03
270  .325531  322  .105481E-01  374  .34972E-03
271  .325072  323  .91137E-02  375  .322593E-03
272  .324613  324  .786745E-02  376  .297577E-03
273  .324154  325  .679336E-02  377  .274534E-03
274  .323695  326  .586616E-02  378  .253236E-03
275  .323236  327  .506748E-02  379  .233591E-03
276  .321445  328  .437483E-02  380  .215506E-03
277  .319609  329  .377812E-02  381  .213532E-03
278  .317865  330  .326265E-02  382  .211558E-03
279  .316075  331  .281741E-02  383  .209963E-03
280  .314285  332  .243276E-02  384  .207702E-03
281  .312541  333  .210089E-02  385  .205821E-03
282  .31075  334  .181447E-02  386  .203939E-03
283  .351694  335  .176123E-02  387  .202057E-03
284  .398008  336  .170982E-02  388  .200221E-03
285  .450427  337  .165978E-02  389  .189296E-03
286  .509732  338  .161113E-02  390  .196594E-03
287  .576885  339  .156385E-02  391  .194804E-03
288  .652851  340  .151841E-02  392  .193014E-03
289  .738778  341  .147388E-02  393  .191224E-03
290  .836088  342  .143074E-02  394  .18948E-03
291  .861518  343  .138897E-02  395  .187735E-03
292  .887498  344  .134812E-02  396  .186037E-03
293  .91435  345  .130864E-02  397  .184339E-03
294  .94212  346  .127054E-02  398  .18264E-03
295  .970625  347  .123336E-02  399  .180988E-03
296  1.00000  348  .11971E-02  400  .179336E-03
297  .990959  349  .116222E-02  401  .177683E-03
298  .982054  350  .112825E-02  402  .176077E-03
299  .973287  351  .10952E-02  403  .17447E-03
300  .96429  352  .106307E-02  404  .172864E-03
301  .886993  353  .103232E-02  405  .171257E-03
30 ~U.5.GOVERNmENTP RINTING O"ICE,1968.201.650,60453