TIA LEB 3-1976 Interpretations of HEW BRH Guide for Submission of Laser Equipment Reports.pdf

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1、EIA LEB3 76 9 3234600 0006235 7 9 7 I W LASER ENGINEERING BULLETIN NO. 3 INTERPRETATIONS OF HEW BRH GUIDE FOR SUBMISSION OF LA.SER EQUIPMENT REPORTS Prepared by the May, 1976 L-I Committee on Laser Safety and Communications Division Laser Section Engineering Department ELECTRONIC INDUSTRIES ASSOCIAT

2、ION - EIA LEB3 7b 3234600 000b2Lb 9 = 1 ic a FOREWORD The central purposes of and b.) Guide (Reference 5) by BRH. to provide advance information on changes which will be made to the These changes include revision of present language found in the January 1976 Guide as well as expected new language in

3、 a revised Guide which will be printed and distributed within the next 30-60 days to the three Bureau of Radiological Health (BRH) mailing lists listed below: 1. Laser Manufacturers (Companies who have submitted Initial Reports) 2. Potential Laser Manufacturers 3. Designated Parties Interested in La

4、ser Manufacturing The BRH staff has reviewed and provided comments on this Bulletin and it is believed that a laser product manufacturer desiring to use this Bulletin in the preparation of required Reports to the BRH in advance of receipt of the BRH revised Guide may do so with a certain amount of c

5、onfidence. Inter- pretations and forthcoming revisions to the Guide are discussed in detail in this Bulletin. i t - EIA LEB3 76 3234600 0006237 O 3 - s TmLE OF CONTENTS 1. Introduction . a, General b. Discussion of Reference Documents 2. Interpretations and Expected Revisions of BRH Guide a. General

6、 b. Use of the Guide by All Manufacturers of Certified c. d. I Laser Products Use of the Guide by All Manufacturers who Incorporate Lasers or Laser Systems into Their Products Use of the BRH Quality Practices Guide 3. BRH Probable Actions upon Receipt of Reports 4. EIA Disclaim of Liabilityin Connec

7、tin with Use of This Bulletin Appendix A Detailed Instructions for Use of the BRH Guide. Appendix B Instructions and Guidelines for Manufacturers who Incorporate Certified Laser Systems into their Products. Appendix C Interpretation and Application of the BRH Quality Control Practices Guide. Appendi

8、x D BRH Letter Announcement of the Availability of an NBS Calibrated Laser Power Meter to all Laser Nanufacturers. Appendix E BRH Sgunple Copy of a Brochure, “Federal Requirements for Laser Product Manufacturers.“ PAGE . - 10 16 17 A- 1 B- 1 c- 1 D- i E- 1 ii EIA LEB3 76 m 3234600 0006218 2 m 1. INT

9、RODUCTION a. General. This set of interpretations of actions needed by a laser equipment manufacturer in.order to comply with the HEW Bureau of RadioJogiCa1 Health, Division of Compliance, Guide for Sumission of Information on Lasers and Products Containing Lasers, was developed in a joint meeting w

10、ith BRH staff and representatives of the EIA Communications Division Laser Section and Laser Safety and Standards Committee on May 13. At this meeting BRH staff agreed to revise the “Guide“ published in January 1976 and encouraged the Laser Section to publish an EIA Engineering Bulletin which includ

11、ed the s policy presented in an early preamble is current unless superceded by policy in a later preamble. f. Guide for Submission of Information on Lasers (Reference (5) ) - This seventy-three page document, which was mailed to all laser manufacturers, potential manufacturers, and designated intere

12、sted parties known to BRH on FeSurry 19, 1976, is intended by tine BRH tio be helpful in detailing the format an information needed to be submitted by laser product manufacturers in reports required by the Regulations (Reference (2) Sections 1002.10 and 1002.12 for products subject to the Federal Pe

13、r- fonnance Standard. As indicated in Sections 1002.10 and 1002.12 a report is required to be submitted to the BFH prior to the introduction of the certified laser product into commerce. The BRHwill acknowledge receipt of the report and will advise the manufacturer of the Accession Number (BRH recor

14、d number) that has been assigned to the report. All subsequent reports dealing with that laser product model, or model family, should use the same Accession Number for cross referencing purposes. Annual Reports are required in accordance with 1002.11 of Reference 2. is considered by BRH as the Initi

15、al Report of products to be certified under the Standard. The first Annual Report on certified laser products is due SeptelIuser 2, 1977, to The Report required by the Guide (Reference 5) cover the year ending June 30, 1977. - i1 EIA LEB3 76 M 3234600 0006225 T M I g. pality Control Practices Guide,

16、 (Reference (6). As indicated in the abstract of this eighteen page document, it was developed and pelished to provide guidance for laser product manufacturers in establishing programs to assure compliance with the Standard (Reference (3). Specific areas of administration and recordkeeping, testing

17、beforet during, and after production, measuring instru- ments selectioi and calibration criteria, sampling criteria, and sales and service information are treated in relation to pergormance and informational requirements of the Standard. Additional discussion of this document will be found in the fo

18、llowing Sections of this Bulletin. h. Availability -._LI.- of Calibrated Laser Power Meter (Reference (?!. This letter advised all laser product manufacturers of a BRH/NBS program to improve methods of measurement of laser radiations and that a laser power meter calibrated at a power level of 1 mill

19、iwatt and at a wavelength of 632.8 nanometers is available to laser product manufacturers and importers or measurement of laser radiation. This instrument will be maintained, calibrated, and shipped to laser product manufacturers by the National Bureau of Standards for comparison with calibration of

20、 the manufacturers laser radiation power measuring equipment. A .copy of this letter is enclosed in this Bulletin as Appendix D. Appendix D also includes some additional information concerning operational aspects of this program. -0- EIA LE63 7b 3234600 000b22b L m 14 - i, Tabulated Values of Access

21、ible Emission Limits for Laser Products (Reference, (8). emission limits for laser radiation which were computed for This document contains the tabu1,ated accessible selected wavelengths and sampling intervals from the formulas presented in Tables 1-A, I-B and I-C of 21 CF,R 1040.10(d). Laser Produc

22、ts: Federal Requirements for Manufacturers (Reference (10). - This pamphlet was prepared for manufacturers who incorporate lasers or laser systems into their products and who may not realize . they may be considered to be manufacturers of Laser products under P.L. 90-602. The pamphlet briefly explai

23、ns what is a Laser product, who is a manufacturer, what is required of a laser product manufacturer under the regulations (21 CFR Chaper I, Subchapter J), and where further information can be obtained. Manufacturers of component lasers and laser systems can be of assistance in distributing the frank

24、ed pamphlet. Multiple copies can be obtained from BRH. A sample copy of the pamphlet is enclosed in this Bulletin as Appendix E. k. Laser Compliance Measurements Handbook (Reference 11). This handbook contains a description of the equipment and protocol intended to be used by BRH and FDA field perso

25、nnel in making radiometric measurements. The handbook presently is in draft form and when finalized will be in loose 1eaf.binding in order . that updating can be facili.tated, BFVcautions manufacturers -9- EIA LEB3 7b m 3234b00 000b227 3 m that the handbook should not be taken as an endorsement of t

26、he instruments used and that changes are likely as improved instruments become available. i3 i 2. INTERPRETATIONS AND EXPECTED I_ REVISIONS OF THE GUIDE (REFERENCE (5). a. General. The following information is intended to be used by a laser product manufacturer who intends to manufacture and sell. a

27、 laser product certified to meet all the requirements of the Standard (Reference (3) to a laser user or another equipment manufacturer. In accordance with References (1) and (2), a manufacturer means any person engaged in the business of manufacturing, assembling, or importing electronic products. R

28、eference (3) contains definitions of “Laser, I “Laser Product, I and “Laser System.“ are those who incorporate a laser into a product whether or not the laser has been certified by the original laser manufacturer, and manufacturers of products intended to incorporate a laser Included in the definiti

29、on of manufacturer or laser system. in certain instances of incorporating a certified laser product into other equipment the manufacturer of that equipment may not have to submit a report or may submit an abbreviated Initial or Model Change Report, If, however, that manufacturer incorporates an unce

30、rtified laser or laser system into his product;, he must submit a full and complete Report. - 10 - h. Use ,of the Guide by all Manufacturers of Certified Laser Products. BRH recommends that manufacturers make copiesof Parts 1, 2, 3, 4 and 6 and use them as a form, In responding to Parts 5, 7, 8, I,

31、and 10 the manufacturer should number each response exactly as the corresponding item in the Guide* is numbered. be retyped or reproduced. However, al1 responses should be It is not necessary that the text of the Guide * clear and unambiguous; If a particular response Xeferences another part of the

32、Report., an attachment, or another report, the reference should be clear, unambiguous, and as specific as possible. If an item in the Guide is clearly not applicable the manufacturer may simply state that with no further explanation. However, if it is not clear, or if it may not Be clear why the ite

33、m is not applicable, an explanation should be provided. Since there will be future revisions of the Guide with some changes in paragraph numbers, the manufacturer is asked to indicate the month of issue of the Guide he uses for his Report at the top of the first page of Part 1. Appendix A is a listi

34、ng of certain paragraph numbers of the Guide in sequence along with any interpretations or guidance in providing necessary responses to that particular paragraph and/or indication of the manner in which it will be modified C. Use of the Guide by Manufacturers Kho Incorporate LESBYC or Laser Systems

35、Into Their Products. nan-cerkified laser (with no power supply or energy source) into a product which includes tho power supply (energy source) Incorporation of a certified or EIA LEB3 7b m 3234600 OOOb229 7 m produces a laser system and results in a laser product with additional requirerpents being

36、 applicable manufacturer in this instance becomes a laser product manufacturer and must certify the new product and submit a complete report The equipment . on it. However, it is acceptable to BRH if the laser manufacturers quality contrbl and test data are included with this report. The product man

37、ufacturers report should show how the laser manu- facturers testing is,valid for the condition of use of the product. In this instance the product manufacturer is responsible. for the laser equipment perEorming in compliance with the by the manufacturer) . A manufacturer who incorpoxates a non-certi

38、fied laser system into another product becomes the “manufacturer“ of record with BRH and must also file a complete report. He may also include the laser system manufacturersqualIty control and test data in accordance with the above guidance. Incorporation of a certified laser system into other produ

39、cts may or may not make the other product manufacturer a laser product manufacturer as discussed below. categorized below which cover some instances. listing of the paragraphs of the Guide which may be answered in whole or in part, by Category C or D manufacturers (described below) through reference

40、s to the certified laser system Several examples are Appendix B is a manufactuEers reports. - 12 - EIA LEB3 76 m 3234600 0006230 3 W r Category A. A.certified laser system is sold by a laser manufacturer and is to be attached by another manufacturer to his product without modification or changing it

41、s intended function for which Section 1040.10 or 1040,ll has an applicable requirement. such that all the labels are intact and can be seen by the product user and all performance features are fully operable. The certifieci laser system manufacturer s service procedures and service adjustment instru

42、ctions will be used as part of the overall service instructions for the other product. instance the laser system manufacturer is the “manufacturer“ of record wiw BRH and no reports are required by BRH from the In this product manufacturer. Category B. A certified laser system is sold by a laser manu

43、facturer and is to be attached by another manufacturer to his product without modification or changhg its intended function far which Section 1040.10 or 1040.11 has an applicable requirement and all the labels will be intact and can be seen by the product user and all performance features are fully

44、operable. However, the product manufacturer provides his own laser product service procedures and service adjustment instructions which follow the laser manufacturers service procedures and instructions. In this instance the laser manufacturer is the “manufacturer“ . of record with BRH and no report

45、s are required by BRH from the product manufacturer. .However, the product manufacturer assumes some liability as far as BRH is c0ncerned.h assuring that user and service information is made available pursuant - 13 - EIA LEB3 76 m 3234600 000b231 5 m . to 21 CFR 1040.10(h) (1) and (2) and in supplyi

46、ng *a copy to BRH citing the certified laser manufacturer Accession Number, with a copy to the certified laser manufacturer. the laser manufacturer to submit the data directly to BRH. Another option is for Categoqr c. A certified laser system is sold by a laser manufacturer in kit form and is to be

47、assembled in, embedded in, or otherwise incorporated into another product in such a manner that the labels or operating controls or indicators will be installed by the other product manufacturer. The laser manufacturer s service procedures I * and service adjustment instructions will be used as part

48、 of the overall service instructions for the other product. stance the product manufacturer becomes the “manufacturer“ of record with BRH and bears the responsibility for certification of the final product and an abbreviated report citing the certified 1acsr.systcm nanufacturers rcpork Accesshi; Num

49、ber should 1=3 filed In this in- by the product manufacturer with the BRH. vided to the product manufacturer along with the certification (This number will be pro- information by the laser system manufacturer.) Category D. and is to be assembled in, embedded in, or otherwise incorporated A certified laser system is sold by a laser: manufacturer 1- hto anocher product in such a manner that the labels, or operating , controls or indicators will be relocated from the laser system enclosure by the product manufacturer. The laser manufacturer