Inspection and Field Testing of Radiation-Emitting Electronic Products: Attachment C: Specific Instructions for Sunlamp Product Inspections and Tests

Published: 2007-10-30

Status: Final Type: Guidance Document Category: Quality / QMSR / Manufacturing Docket: FDA-2020-D-0957

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https://www.fda.gov/regulatory-information/search-fda-guidance-documents/inspection-and-field-testing-radiation-emitting-electronic-products-attachment-c-specific

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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 sunlamp products are also medical devices, they are subject to the Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act, including the Good Manufacturing Practices (GMP) regulations developed under the authority of that Act. All manufacturers of sunlamps and sunlamp products and ultraviolet lamps must establish and implement GMPs to ensure that the devices conform to their specifications, and implement quality control procedures to ensure compliance with the Federal performance standard. This guide has been prepared to assist manufacturers in satisfying the G MP requirements 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 procedures 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 manufacturing 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 ~ ii Foreword iii

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. Sunlamp Products

A. Performance

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 Emission Controls a. Verify that there is a user control on the sunlamp product that will terminate radiation emission at any time without disconnecting the electrical 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 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." Verify that the following recommendations, directions, warnings, and statements 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 recommended exposure schedule that complies with CDRH policy statement 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. 3. 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 medium screw" 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.

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.
4. ,A~ clear 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; "Response time", .QA; "Jog", normal; "Sphere position", ill.
5. "JR.anging" manual, use pushbuttons to set to the XIO-O range.
6. S,et switches 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 Q¥l, the "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. ,;jj

II. Set-Up

A. 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.Y1Q range.

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 HeN e 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.
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. Respond to 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. Sunlamp Test

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.

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. I

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.
6. Initial set-up control settings: "Powl~r" switch QN. "Func~tion" switch ~ "Mode" switch ~ "Source Select" switch y!§ "VV Source" switch ~ "VIS Source" switch !llilli
7. 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~ clip 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.
8. 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.
9. 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
10. Using' the knob on the left side of the cabinet, set the wavelength to 375 nm.
11. Set the chart speed so that the pen will start on a line. chart drive toggle switches. Turn on wavelength and
12. Turn "Scan Switch" to "-". When wavelength reaches 200 nm, turn off.
13. Turn off pen and chart switches and turn "Mode" switch to ~.
14. Open the sample chamber, remove the universal positioning jig and eyewear, and replace the cell holders.
15. Put E!yewear on. Determine if labels and timer graduations can be re~d. determine if there are light leaks around the eyewear. Also ,:tI ,O'i'" ,'"ii" APPENDIX C POLICY ON MAXIMUM TIMER INTERVAL AND EXPOSURE SCHEDULE FOR SUNLAMP PRODUCTS ':'ji
    1;11 I~ \J DEPARTNIENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Aug. 21, 1986 Rockville MD 20857 ALL MANUFACTURERS, IMPORTERS AND POTENTIAL MANUFACTURERS OF SUNLAMP PRODUCTS TO: SUBJECT: POLICY ON MAXIMUM TIMER INTERVAL AND EXPOSURE SCHEDULE FOR SUNLAMP PRODUCTS BACKGROUND: The amended performance standard for sunlamp products (21 CFR 1040.20) was 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): 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 """' V.R. L I I T = e 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 it Walter E. Gundaker, Director Office of Compliance Center for Devices and Radiological Health Appendices ;;8;' 1 ~. "'" c,' c

Appendix A (page 1) Weighting factors for erythema, Vi -4 L 0 9 0 f -3 W e R t -2 n F a c t 0 r s -1 a 275 325 375 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 (159-..) (325 < ;\ < 405 nm)

! Appendix B (page 1) Weighting factors for melanogenesis, Ji 1.0E +00 W e I h 1.0E-01 t i n F 1.0E-02 a c t 0 r 1.0E-03 Jj 1.0E-O4 400 450 250 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) Appendix B (page 1) Parrish Melanogenesis Type II Skin 1982 Normalized to 296 nm Wavelen~h Ji Wavelen~h Ji Wavelen~h Ji- .378409 .815892 .100202E-02 .374828 ..750391 .972644E-03 .371428 .690261 .944186E-03 .366714 .502296 .916645E-03 .364225 .36551 .890022E-03 .360783 .265997 .863859E-03 .35734 .193565 .838613E-03 .353943 .14087 .813826E-03 .350547 .102497 .789958E-03 .347196 .745893E-01 .767007E-03 .343891 .054301 .747729E-03 .340632 .395016E-01 .722942E-03 .337419 ..341137E-01 .666943E-03 .334206 .294593E-01 .615075E-03 .331039 .254384E-01 .567338E-03 .327672 .219683E-01 .523272E-03 .327413 .189709E-01 .48288E-03 .326954 .163821E-01 .44547E-03 .326449 .141467E-01 .410953E-03 .32599 .122143E-01 .379097E-03 .325531 .105481E-01 .34972E-03 .325072 .91137E-02 .322593E-03 .324613 .786745E-02 .297577E-03 .324154 .679336E-02 .274534E-03 .323695 .586616E-02 .253236E-03 .323236 .506748E-02 .233591E-03 .321445 .437483E-02 .215506E-03 .319609 .377812E-02 .213532E-03 .317865 .326265E-02 .211558E-03 .316075 .281741E-02 .209963E-03 .314285 .243276E-02 .207702E-03 .312541 .210089E-02 .205821E-03 .31075 .181447E-02 .203939E-03 .351694 .176123E-02 .202057E-03 .398008 .170982E-02 .200221E-03 .450427 .165978E-02 .189296E-03 .509732 .161113E-02 .196594E-03 .576885 .156385E-02 .194804E-03 .652851 .151841E-02 .193014E-03 .738778 .147388E-02 .191224E-03 .836088 .143074E-02 .18948E-03 .861518 .138897E-02 .187735E-03 .887498 .134812E-02 .186037E-03 .91435 .130864E-02 .184339E-03 .94212 .127054E-02 .18264E-03 .970625 .123336E-02 .180988E-03 1.00000 .11971E-02 .179336E-03 .990959 .116222E-02 401 .177683E-03 .982054 .112825E-02 402 .176077E-03 .973287 .10952E-02 403 .17447E-03 .96429 .106307E-02 404 .172864E-03 .886993 .103232E-02 405 .171257E-03 ~U.5.GOVERNmENT PRINTING O"ICE,1968.201.650,60453