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SEMI S2-0703a E © SEMI 1991, 2004 72 RELATED INFORMATION 10 LASER CERTIFICATION REQUIREM ENTS BY REGION OF USE NOTICE : This rel ated information i s not an of ficial part of SEMI S2 and was de rived from practical appli…

SEMI S2-0703a

Equipment

Safety Features

(not an inclusive

list)

USA

Europe

Japan

21 CFR

1040.10

60825-1

JIS 6802

Paragrap

Examples

10. Manual Reset

Mechanism

( ) Yes

( ) No

(f)(10) 4.3.1 4.2.2(c) A button or circuit that must be

energized before the equipment

resumes its functions.

11. Class

Designation &

Warning Labels

( ) Yes

( ) No

(g) 5 4.3 Identify which standard was used

for each hazard classification.

12. Aperture Label ( ) Yes

( ) No

(g)(5) 5.7 4.3.7 Identify the aperture.

13. Positioning of

Labels

( ) Yes

( ) No

(g)(9) 5.1 4.3.1 Conspicuous, but size is not

specified.

14. User

Information

( ) Yes

( ) No

(h)(1) 6.1 4.4.1 SOPs, instruction manuals

15. Service

Information

( ) Yes

( ) No

(h)(2) 6.2 4.4.2 Accessible laser radiation levels

during Service

16. Measurements ( ) Yes

( ) No

(e) 8 3.4

17. Classification ( ) Yes

( ) No

18. Certification

Information

21 CFR TBD by

Europe

TBD by

Japan

19. Certification

Label

( ) Yes

( ) No

1010.2

20. Identification

Label

( ) Yes

( ) No

1010.3

SEMI S2-0703a

RELATED INFORMATION 10

LASER CERTIFICATION REQUIREMENTS BY REGION OF USE

NOTICE: This related information is not an official part of SEMI S2 and was derived from practical application by

task force members. This related information was approved for publication by vote of the responsible committee on

October 21, 1999.

Table R10-1 Regional Laser Standards

USA Europe Japan Pacific Rim

Classification Standards 21 CFR 1040.10 EN 60825-1 JIS C 6802 IEC 60825-1

Certification Standards 21 CFR 1000-1010 TBD TBD TBD

R10-1 USA

Food and Drug Administration (FDA)

Center for Devices and Radiological Health (CDRH)

R10-1.1 Laser products must comply with the

performance requirements of Title 21 of the Code of

Federal Regulations Part 1040.10 (21 CFR 1040.10).

Manufacturers (including modifiers) of laser products

must certify to the FDA/CDRH in writing that the

product complies with the requirements of 21 CFR

SubChapter J.

R10-1.2 The reporting requirements are detailed in 21

CFR 1000–1010. Product report forms and the guidance

document are available from the CDRH. These

documents should soon be available from the CDRH

Web server at:

http://www.fda.gov/cdrh

R10-1.3 The CDRH Office of Compliance can be

reached by telephone at (301) 594-4654

R10-1.4 The CFR references may be obtained by

searching the website at:

http://www.access.gpo.gov/nara/cfr/cfr-table-

search.html

but these documents do not include figures or tables.

R10-1.5. When a laser product is imported, the

importing company is considered the laser

manufacturer and must certify the laser product.

R10-2 Europe

International Electrotechnical Commission (IEC)

R10-2.1. European governments have adopted IEC

60825-1 as the laser product safety standard.

Manufacturers of laser products should comply with

Section 2 of the IEC 60825-1 document. An IEC

committee is currently working on a checklist for laser

product manufacturers to follow to assess compliance

with the IEC document. Other IEC 60825 series

documents may apply to the product either now or in

the future.

R10-2.2. EN 60825-1 is the normative standard, which

has been adopted by the European Union and EFTA

countries.

R10-2.2.1 The EN 60825-1 should be available

through the various European government agencies or

government printing offices.

R10-2.3. The laser product manufacturer should review

ISO 11553 for requirements that apply to laser

equipment that processes materials.

R10-2.4. The IEC document can be obtained from:

International Electrotechnical Commission

3, rue de Varembé • PO Box 131

1211 Geneva 20 • Switzerland

Tel: +41 22 919 02 11 • Fax: +41 22 919 03 00

or other participating national standards association

(available on websites).

R10-2.5. The ISO document can be obtained from:

International Standards Organization (ISO)

1, rue de Varembé

Case postale 56

CH-1211 Genève 20

Switzerland

Telephone: + 41 22 749 01 11

Telefax: + 41 22 733 34 30

or other participating national standards association

(available on websites).

R10-2.6 The IEC Website is located at:

http://www.iec.ch

R10-2.7 The ISO Website is located at:

http://www.iso.ch/

SEMI S2-0703a

R10-3 Japan

R10-3.1. The Japanese Safety Association published an

English version of the Japanese laser safety standard

based on the IEC 60825 series document. This standard

is Japanese Industrial Standard (JIS) C 6802. The

Japanese version is still the official standard, but the

English version has the warning hazards described with

the Japanese symbols in the images.

R10-3.2. As in the IEC document the manufacturing

requirements are specified in Section 2. There is a

companion document JIS C 6801 that provides the

Glossary of terms and their translations into English.

R10-3.3. The JIS documents can be obtained through

the Japanese Safety Association.

R10-3.4. Japanese Standards Association

1-24 Akasaka 4

Minato-Ku

JP-107 TOKYO

TP: +81 3 3583 80 03

TF: +81 3 3586 20 29

http://www.jsa.or.jp/eng/catalog/frame.html is

searchable

R10-3.5. Websites:

(In English) http://www.hike.te.chiba-

u.ac.jp/ikeda/JIS/index.html

(In Japanese) http://www.jsa.or.jp

R10-4 Other (e.g., Pacific Rim)

R10-4.1 The manufacturer is responsible to determine

the appropriate standard to use in other countries.

R10-4.2 In the absence of any specific standard for a

country, the IEC 60825-1 document should be used as

the guide for compliance

R10-4.3 In many countries, prefectures, states, or

provinces, local laser safety regulations exist. Much of

this regulation is aimed at the user, but may include

product performance requirements. The manufacturer

has the responsibility to identify these requirements.

R10-4.4 Addresses of many national standards

organizations are found at:

http://www.iec.ch/cs1sot-e.htm