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SEMI S2-0703a E © SEMI 1991, 2004 101 DELAYED REVISIONS SECTION 2 (EFFECTIVE JULY 1, 2006) SEMI S10 CHANGES TO SEMI S2 NOTICE: Th is Delayed Revisions Sec tion contains mat erial that has been b alloted and approved by t…

SEMI S2-0703a

Reference

Number

Equipment

Safety Features

(not an inclusive

list)

USA

21 CFR

1040.10

Europe

ENIEC

60825-1

Japan

JIS

C 6802

Examples

11. Class

Designation &

Warning Labels

( ) Yes

( ) No

(g)(1)-

(g)(4)

5.1-5.6,

5.8-5.11

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

9 3.4

17. Classification ( ) Yes

( ) No

8 3.3.3

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

A. The US FDA/CDRH makes 21 CFR 1040.10 available, so the latest version should be used. The version used to update this table was dated

April 1, 2003.

B. The IEC laser products standard used to update this table was 60825-1 © IEC:1993+A1:1997+A2:2001(E)

C. The Japanese Standards Association does not offer the current version of JIS C 6802 in English.

However, the current version should be used and the Japanese version is the official version

The sections referenced in the table above are from the 1991 English version of C 6802.

D. This requirement applies only to certain classes of lasers.

NOTE 4: Both the IEC and the US FDA/CDRH have published guides to assist manufacturers with laser product conformance.

NOTE 5: The FDA/CDRH has published Laser Notice 50. This laser notice provides guidance to manufacturers relating to the

FDA/CDRH acceptance of laser products conforming to the IEC 60825-1 standard. There are conditions and additional

requirements, so manufacturers should obtain this laser notice for the details.

R9-2 Referenced Documents

R9-2.1 IEC Standards

IEC 60825-1 — Safety of Laser Products, Part 1: Equipment Classification, Requirements, and User’s Guide

R9-2.2 US Code of Federal Regulations

21CFR Parts 1000-1050 — Food and Drug Administration / Center for Devices and Radiological Health

(FDA/CDRH), Performance Standards for Electronic Products, Title 21 Code of Federal Regulations, Parts 1000-

1050

26 International Electrotechnical Commission, No. 3, rue de Varembé, Case Postale 131, CH-1211 Geneva 20, Switzerland. Telephone:

41.22.919.02.11; Fax: 41.22.919.03.00. Website: www.iec.ch

27 United States Food and Drug Administration/ Center for Devices and Radiological Health (FDA/CDRH). Available from FDA/CDRH

Website: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm

SEMI S2-0703a

DELAYED REVISIONS SECTION 2 (EFFECTIVE JULY 1, 2006)

SEMI S10 CHANGES TO SEMI S2

NOTICE: This Delayed Revisions Section contains material that has been balloted and approved by the

SEMI Environmental Health and Safety Committee, but is not immediately effective. The provisions of this

material are not an authoritative part of the document until their effective date. The main body of SEMI S2-

0703 remains the authoritative version. Some or all of the provisions of revisions not yet in effect may

optionally be applied prior to the effective date, providing they do not conflict with portions of the

authoritative version other than those that are to be revised or replaced as part of the deferred revision, and

are labeled accordingly.

NOTICE: Unless otherwise noted, all material to be added shall be underlined

, and all material to be deleted shall

be struck through

D2-1 Revisions to Section 5 (Terminology) — OPTIONAL Before Effective Date

D2-1.1 Addition of the following at the beginning of Section 5.2 (Definitions):

NOTE #: Composite reports using portions of reports based upon earlier versions of SEMI S2 and SEMI S10 may require

understanding of the SEMI S2-0703 or SEMI S10-12-96 definitions for the terms hazard, likelihood, mishap, severity, and risk.

D2-1.1 Addition (in alphabetical order), deletion, and revision of the following in Section 5.2 (Definitions):

5.2.# harm — physical injury or damage to health of people, or damage to equipment, buildings or environment.

5.2.25 hazard — a condition that is a prerequisite to a mishap

condition that has the potential to cause harm.

5.2.38 likelihood — the expected frequency with which a mishap will occur. Usually expressed as a rate (e.g.,

events per year, per product, or per substrate processed). the expected frequency with which harm will occur.

Usually expressed as a rate (e.g., events per year, per product, or per substrate processed).

5.2.44 mishap

— an unplanned event or series of events that results in death, injury, occupational illness, damage to

or loss of equipment or property, or environmental damage.

5.2.60 risk — the expected losses from a mishap, expressed in terms of severity and likelihood.

the expected

magnitude of losses from a hazard, expressed in terms of severity and likelihood.

5.2.64 severity — the extent of the worst credible

loss from a mishap caused by a specific hazard. the extent of

potential credible harm.

D2-2 Revisions to Section 6.5 — OPTIONAL Before Effective Date

D2-3.1 Revision of the following in Section 6.5:

NOTE 7 The intent is to control single fault conditions that result in significant risks (i.e., Critical

Very High, High, or Medium

risks based on the example risk assessment matrix in SEMI S10).

NOTE #: The risk category of “Very High” corresponds identically to the risk category, used in previous SEMI documents (e.g.,

S10-1296, SEMI S2, and SEMI S14) of “Critical”. The term was changed to facilitate translation from English.

D2-3 Revisions to Section 6.8.1 — OPTIONAL Before Effective Date

D2-3.1 Revision of the existing Section 6.8.1 as shown below:

6.8.1 The hazard analysis should include consideration of:

 the application or process;

 the hazards associated with each task;

 anticipated failure modes;

 the probability of occurrence and severity of a mishap

harm;

 the level of expertise of exposed personnel and the frequency of exposure;

SEMI S2-0703a

 the frequency and complexity of operating, servicing and maintenance tasks; and

 safety critical parts.

NOTE #: The term mishap was replaced with the results of harm in the SEMI S10 1103 revision.

D2-4 Revisions to Section 11.6 — OPTIONAL Before Effective Date

D2-4.1 Revision of the following in Section 11.6:

NOTE 26: Where a safety interlock is provided to safeguard personnel from a

severe or catastrophic mishap harm as categorized

by SEMI S10, consideration of positive-opening type of switches is recommended.

NOTICE: Paragraphs entitled “NOTE” are not an official part of this safety guideline and are not intended to

modify or supersede the official safety guideline. These have been supplied by the committee to enhance the usage

of the safety guideline.

SEMI makes no warranties or representations as to the suitability of the guideline set forth herein for any particular

application. The determination of the suitability of the guideline is solely the responsibility of the user. Users are

cautioned to refer to manufacturer’s instructions, product labels, product data sheets, and other relevant literature

respecting any materials mentioned herein. This guideline is subject to change without notice.

The user’s attention is called to the possibility that compliance with this guideline may require use of copyrighted

material or of an invention covered by patent rights. By publication of this guideline, SEMI takes no position

respecting the validity of any patent rights or copyrights asserted in connection with any item mentioned in this

guideline. Users of this guideline are expressly advised that determination of any such patent rights or copyrights,

and the risk of infringement of such rights, are entirely their own responsibility.

International), 3081 Zanker Road, San Jose, CA 95134. Reproduction of

the contents in whole or in part is forbidden without express written

consent of SEMI.