1、* -c EIA LEB2 70 3234600 OOObL9L 8 W 7 - LASER ENGINEERING BULLETIN NO. 2 Guidance For Laser Record Keeping And Reporting Under The Radiation Control For Health And Safety Act Of 1968 September 1970 Eim3ring Dsparhnent ELPCTRONIC INDUSTRIES ASSOCIATION EO01 EYE STREET, N. W. WASHINGTON. D. C. 20006
2、i - . -_ EIA LEB2 i0 3234b00 OOOb392 T LASER ENGINEERING BULLETIN NO 2 . SAFEXY CLASSIFICATION OF LASER EQUIPMENT AND RGTALLATIONS Prepared by the . EU Laser Subdivision Government Liaison Ad Hoc Committee, the L-2 Laser Safety Committee, and the L-2 Standards Comnittee. ELECTRONIC INDUSTRIES ASSOCI
3、ATION ENGINEERING DEPARTMENT EIA LEB2 70 3234600 000bL93 L * This bulletin was developed by the EU ?iaser Subdivision Government Liaison Ad Hoc Committee with principal inputs from mmbenss of the Laser Safety (L-1) committee and the Laser Standards (i,-2) Committee, ntrepretaticms of Bureau of Radio
4、logical Health (BRH) reporting re- . quirements appearing in this Bulletin were discussed informally with BRH personnel who indicated general agreement on 21 August 3970, Hawever, it is emphasized that nothing stated in this Bulletin should be inferred as representing the official BRH position an Ch
5、ie eaibjact or binding BRH to blanket acceptance of reports prepared using this Bulletin as a guide. t: EIA LEB2 ?O 3234600 0006394 3 1 Under the Radia-ion Con 1 INTRODUCTION rol fo Health and Safety Ac- of 1968 I (Public Law 90-602), electronics manufacturers are required to file with the Bureau of
6、 Radiological Health (BRH) of the Department of Health, Education, and Welfare certain reports and maintain certain records concerning specific kinds of listed electronic products and components, including lasers and products containing lasers. The Act also requires record keeping by dealers and dis
7、tributors of various products but lasers and laser products are excluded pending issuance of a laser performance standard. for all existing lasers and products or devices containing lasers currently being manufactured. These reports are due to BRH no later Initial Reports must be submitted than Sept
8、ember 25, 1970, or prior to introduction of the product into commerce, whichever is la ter. 2. PURPOSE AND SCOPE The purpose of this Bulletin is to provide a summary of the laser product record keeping and reporting requirements under the Act foi. the guidance of laser manufacturers, dealers, and di
9、stributors who are required to develop and submit such reports. The scope of this Bulletin is limited to laser products. 3. ADDRESS All reports required under the Act are to be submitted to: Director, Bureau of Radiological Health 5600 Fishers Lane Rockville, Md. 20852 -1- EIA LEB2 70 m 3234b00 OOOb
10、375 5 m 4. REFERENCES Particulars concerning requirements under the Act within the Scope of the Bulletin are to be found in Public Law 90-602, 90th Congress, October 18, 1968 and in the following issues of the Federal Register, available from the Superintendent of Documents, Washington, D. C,: (a) S
11、ubpart H: Fed. Reg. Vol. 35, No. 104-Thursday, May 28, 1970, pp 8363-5. (b) Subparts B, F and G: Fed. Reg., Vol. 35, No. 15-Thursday, January 22, 1970, pp 889-894. (c) Subpart C: Fed. Reg., Vol. 34, No. 247-Thursday, December 25, 1969, pp 20273-20275. 5. LASER PRODUCT GROUPS All lasers have been cla
12、ssified under the regulations into two product groups, designated “Group A“ and “Group C“ (Group B does not include any lasers). Lasers in “Group AIt are of lower average power density (wa t ts/cm2) than those in Croup C“ . prepared to assist in the determination of the proper laser group. Figures 1
13、-3, attached , have been Figure 1 pertains essentially to CW lasers, Fig. 2 to long-pulse lasers (10-6) to 10-1 sec), and Fig. 3 to short pulse (including Q-switched) lasers ( 6. RECORD KEEPING AND REPORTING REQUIREMENTS AS SUMMARIZED FROM THE REFEUNCED DOCUMENTS, , 6.1 SUMMARY 6.1.1 For all lasers
14、and models containing lasers (Reference: Subparts H and F): (a) For products currently in production other than those intended solely for export or to be sold exclusively to other manufacturers - 2- EIA LEB2 70 3234600 000bL9b 7 M I. . for use as components of electronic products to be sold to purch
15、asers, Initial Reports and Model Change Reports are to be submitted by the laser or equipment manufacturer (for exceptions see Section 6.21 below). Initial Reports are to be received by BRH by September 25, 1970 or prior to introduction into conmerce, whichever is later. The contents of the Initial
16、Reports are listed in Section 6,3 below. Change Reports, for new or modified models of a listed product for Model which an Initial Report was filed, are to cover changes in the information submittedin an Initial Report. A suggested reporting form for both Reports is appended to this Bulletin. (b) Ac
17、cidental radiation occurrence reports are to be furnished imdiately by the manufacturer for any event which results in injurious or potentially injurious exposure of any person to laser radiation. (c) Defective product notifications are to be furnished immediately by the manufacturer if a product wh
18、ich has left the place of manufacture has a radiation defect or fails to comply with a Federal Standard. Notices are to be sent to first purchasers, distributors, or dealers to whom shipped, and, where known, to transferees. Notices and copies of all correspondence are to be sent to the Secretary, “
19、W. 6.1.2 For Group4 laser products (Reference: Subpart H): (a) Records are to be established by manufacturers, dealers, and distributors, as explained in Section 6.4 below, and preserved for five years from the date o? record. (b) .Starting September 1, 1971, annual reports will be required from the
20、 manufacturers covering the 12 months ending June 30 and summarizing the contents of these records. EIA LEB2 70 M 323qbOO 000bi197 9 M _. 6.1.3 For lasersand laser products when applicable Federal Staodards prescribed under the Act are issued* (References: when issued): (a) Subparts C and G and futu
21、re subparts, At the time of delivery, certification labels must be permanently affixed by the manufacturer Qhich certify on the basis of a. test of the individual product or a quality control testing program which is in accordance with good manufacturing practice tha-t the products conf.orm to the s
22、tandards. (b) Before shipment, manufacturers labels must be permanently affixed which give the manufacturers name, address, and the month, year, and place of manufacture. If the information is coded, the Secretary of HEW must be furnished the key to the code. Prior to offering a product for import,
23、the manufacturer shall designate (c) to the Director, BRH, a permanent resident of the.United States as the manufacturers agent. 8 6.2 EXEMPTIONS (Reference: Subpart H) 6.2.1 Exemptions from record keeping and reporting requirements (except product , defect and accidental radiation occurrence report
24、s): (a) Products intended solely for export if so labelled and if the product defect and accidental radiation occurrence reports): Products sold exclusively to other manufacturers for use as components of.electronic products to be sold to purchasers. (b) 1 (C) Upon application, the Director, BRH, ma
25、y-exempt, any product intended for use by departments or agencies of the United States, provided that procurement specifications governing radiation are prescribed and the product is of a type used solely or predominantly by departments or agencies of the United States. *Note: The requirementsoutlin
26、ed in paragraph 6.1.3 do not apply until applicable Federal Standards on laser products have been issued. As of the date of this Bulletin none have been issued. -4- EIA LEB2 70 3234b00 0006398 O = 0 6.2.2 Exemptions from annual report and record keeping requirements for Group C lasers: (a) Manufactu
27、rer may submit with or subsequent to submission of the Initial Report, a request for exemption, together with accompanying justification. The justification must provide documented evidence that the product or product type cannot emit radiation in sufficient intensity or of such quality under any con
28、dition of use or product failure to be hazardous; ar is produced in small numbers and is to be used by trained individuals. (b) The Director, BRH, may exempt manufacturers from all or part of the record keeping and reporting requirements on the basis of information submitted or such other informatio
29、n he may possess. 6.3 mT s (Reference: Subpart H) (a) General Ins truc tions For each product being reported certain information, outlined below, O must be furnished. In arranging the report format it seems reasonable that any of the following options might be exercised: (1) one report could be subm
30、itted for a group of models for which the required data is identicali(2) one. report could be submitted for a group of models for which some information is identical and the non-identical information geparately tabulated for each model; (3) a separate report could be submitted for each model; format
31、 which the manufacturer feels is appropriate and whch furnishes the required information, (4) the report could be arranged in any other A suggested report for.nat is attached, In addition to the name of the electronic product and the appropriate model number or numbers, the report should include ali
32、sting of information 1) under the following headings: 2) Product Group Designation Product Identification ,Functional Description - 5- . . _-. . . . _ - I EIA LEB2 70 3234600 000bL99 2 W Operational Characteristics of Accessory Equipment -1 Radiation -Safety StandardJor Design Specifications Charact
33、eris tics Incorporated to Meet Radiation Safety Standards Methods for Control of Unnecessary Pr0duc.t Radiation Radiation Safety Quality Control Test Procedures Basis for Selection of Quality Control Test Procedures Tests for Durability and Stability with R,espec,t to Radiation Safety Basis for Sele
34、ction of Durability and Stability Test Methods4) Radiation Safety Warning Signs and Labels Furnished,with Product Radiation Safety Instructions Furnished for Installation and peratio 4) n - (b) Detailed Instructions Detailed instructions and interpretive information is contained in Appendix A of Sub
35、part H and Attachment 1 of this Bulletin, The printed portions are direct except from the applicable Federal Register Publi- cat ion. (c) MaiIing of Reports Reports should be mailed to: Director, Bureau of Radiological Heal th 5600 Fishers Lane Rockville, Md. 20852 NOTES : 1. 2. Product will be Grou
36、p A or Group C. 3. Reference may be made to a Federal standard, if appficable. 4. y_ Indicate “unchanged“ after heading if the information is the same as was previously reported for that model, If the product will not produce increased radiation wPth agehg,then indicate “not applicable“, and give th
37、e basis for Chis decision as required by paragraph 78.710 (g) of Subpart H. .-6- -. EIA LEB2 70 m 3234600 O006200 5 m O O MANUFACTURER : ADDRESS : RADIATION CONTROL FOR HEALTH AND SAFETY ACT OF 1968, SUBPART H For Listed Electronic Products Initial Report 0 Model Change Report ( ) Reports are attach
38、ed herewith on the following electronic products: Item No, Name of Electronic Product . Model Number PREPMD BY: APPROVED BY TITLE : DATE : “ EIA LEB2 70 3234600 000b20L 7 6.4 6.4.1 By Manufacturers: RECgRDS TO BE MAINTAINED FOR GROW C PRODUCTS (Reference: Subpart H) (a) Records shall be preserved fo
39、r a period of 5 years from the date of record, (b) The Department of HEN shall be permitted to inspect these records upon request, Record the description of quality control procedures with respect to electronic product radiation safety, (C) (c) Record the results of tests for electronic product radi
40、ation safety; methods, devices, and procedures used and the basis for their selection. (e) For products displaying ageing effects which may increase electronic product radiation, the results of durability and stability tests and thebasis for test selection should be recorded. (f) . Copies of written
41、 communications between manufacturers and dealers, distributors and purchasers concgrning electronic product radiation safety should be maintained. Records of distribution of products to allow tracing of specific (g) products or lots to distributors or directly to dealers should be maintained. Recor
42、ds received from dealers or distributors for tracing of product to purchaser should be maintained. (h) 6.4.2 When an applicable Federal performance standard for lasers is issued, records are to be maintained for a period of 5 years from the date of sale, award, or lease for those laser3 or laser pro
43、ducts with a retail price of not less than $50. to permit tracing of a specific product to a specific purchaser, Sufficient information shall be maintained -8- EIA LEB2 70 m 3234b00 000b202 9 m ATTACHMENT 1 Development of Information Required for Initial Reports Required of Manufacturers of Listed L
44、aser Products (Subpart H, Paragraph 78.710. (a) through (h). (a) State in the report for each model of a Usted product whether the teport is submitted pursuant to paragraph ta), (b), or (cl of 6 78.700. a. General: All lasers have been classified under BRH regulations into two product groups designa
45、ted “Group A“ and “Group C“ (Group E does not include any lasers). Lasers in Group A are of lower average power density (wattslcm2) ox pulse energy density (joules/crn2 than those in Group C, Bu The applicable Group for a laser is determined from the formul-a Ny as found in Subpart H, Section 78.750
46、 Appendix A. N is the reporting index; B for a given wavelength is determined from Table 1 of Appendix A; U is the radiact energy in joules. For continuous wave operation U is radiant energy per second (watts). For single pulse operation U is. the true Ladiant energy per pulse. A is the actual beam
47、area in square centimeters. The values for these parameters should be self-consistent and result in the highest expected index number within the Uperating capability of the device, SUBPART H - APPENDIX A Wavelength in Table 1 Values of B for different b. Formula Application: 2 1 17 200 10 100 1, Mea
48、sure the total radiated energy output: U at the exit port of the laser housing, 1- 1 I EIA LEBZ 70 m 3234600 O006 203 O 2, Measure or calculate the actual cross sectional area of the laser beam in centimeters squared at a distance of 30 cms. from the exit port for collimated and divergent beams;or a
49、t the point of minimum cross Sectional area for convergent beam, The area used should be no larger than that which contains 85% of the. radiated output energy. 3. Calculate N from the formula. The attached Figures 1, 2, and 3, have been prepared using the formula and can be used as an aid for determining the appropriate group for a laser. Figure 1 pertains essentially to CW lasers, Figure 2 tolong-pulse lasers, rind Figure 3 to short-pulse (including Q-switched) lasers. These figures describe radiative output of the laser or laser product in watt
