semi合集-English.pdf - 第6842页

SEMI S2-0703a E © SEMI 1991, 2004 71 Equipment Safety Features (not an inclusive list) USA Europe Japan 21 CFR 1040.10 EN 60825-1 JIS 6802 Paragrap h Paragrap h Paragrap h Examples 10. Manual Reset Mechanism ( ) Yes ( ) …

SEMI S2-0703a

Laser Control Measures

1. Identify protective measures required during maintenance. __________________

____________________________________________________________________

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

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

4. 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)

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

2. OD of PPE required during service activities: ___________

3. Recommended PPE manufacturer and model #: ______________________________

Table R9-1 Equipment Safety Features

Equipment

Safety Features

(not an inclusive

list)

USA

Europe

Japan

21 CFR

1040.10

60825-1

JIS 6802

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 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.

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/