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SEMI S2-0703a E © SEMI 1991, 2004 100 Reference Number Equipment Safety Features (not an inclusive list) D USA 21 CFR 1040.10 A Europe EN IEC 60825-1 B Japan JIS C 6802 C Examples 11. Class Designation & Warning Labe…

SEMI S2-0703a

D. Collecting optics type: ________

E. Focal length in millimeters (mm): ________

Laser Control Measures

Identify protective measures required during maintenance. __________________

____________________________________________________________________

Laser Controlled Area required for Maintenance procedures? ( ) Yes ( ) No

Laser Controlled Area required for Service procedures. ( ) Yes ( ) No

If a Nominal Ocular Hazard Distance (NOHD) is used as a control measure, then provide the NOHD

calculations. See IEC 60825-1 for NOHD calculations.

NOTE R9-2: Attach a diagram of the laser beam path and the irradiance/radiant exposure at each significant point.

Personnel Protective Equipment (PPE) (for laser radiation hazards in excess of the MPE)

Optical Density (OD) of PPE required during maintenance activities: ___________

OD of PPE required during service activities: ___________

Recommended PPE manufacturer and model #: ______________________________

Table R9-1 Equipment Safety Features Reference Table

Reference

Number

Equipment

Safety Features

(not an inclusive

list)

USA

21 CFR

1040.10

Europe

ENIEC

60825-1

Japan

JIS

C 6802

Examples

Paragrap

aragrap

Paragrap

Examples

1. Protective

Housing

( ) Yes (

) No

(f)(1) 4.2 4.2.1 Aluminum or steel enclosures,

windows that provide adequate

attenuation, optical fibers or

beam tubes.

2. Safety

Interlocks

( ) Yes

( ) No

(f)(2) 4.3 4.2.2 See Interlock

Section 11 of

SEMI S2.

3. Remote

Interlock

Connector

( ) Yes

( ) No

(f)(3) 4.4 4.2.3 Usually a 12 to 24 volt set of

contacts available to the user to

integrate additional room control

measures.

4. Key Control ( ) Yes

( ) No

(f)(4) 4.5 4.2.4 A key that is not removable in

the operations mode.

5. Laser Radiation

Emission

Warning

( ) Yes

( ) No

(f)(5) 4.6 4.2.5 A light or indicator that warns

the user of the emission through

the aperture.

6. Beam

Attenuator

( ) Yes

( ) No

(f)(6) 4.7 4.2.6 Shutters, beam blocks or water-

cooled beam dumps

7. Location of

Controls

( ) Yes

( ) No

(f)(7) 4.8 4.2.7

8. Viewing Optics ( ) Yes

( ) No

(f)(8) 4.9 4.2.8 Must block all hazardous

wavelengths to acceptable

levels.

9. Scanning

Safeguard

( ) Yes

( ) No

(f)(9) 4.10 4.2.9 Shuts down if the scanning

mechanism (such as a rotating

mirror or galvanometer) fails.

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.

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.

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;