semi合集-English.pdf - 第6844页

SEMI S2-0703a E © SEMI 1991, 2004 73 R10-3 Japan R10-3.1. The Japanese Safet y Association published an English versi on of the Japa nese laser safety standard based on the IEC 60825 series document. This st andard is Ja…

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

SEMI S2-0703a

RELATED INFORMATION 11

OTHER 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.

R11-1 Japan — Earth Leakage Breaker/Ground

Fault Circuit Interrupter/Ground Fault

Equipment Protection Circuit Interrupter/

Residual Current Devices

R11-1.1 Japanese regulations may require the use of

Ground Fault Circuit Interrupter (GFCI), Ground Fault

Equipment Protection Circuit Interrupter (GFEPCI),

Residual Current Devices (RCD), or Earth Leakage

Breaker (ELB) with the equipment.

EXCEPTION 1: The rating of the equipment is less

than 20 amperes and less than 150 volts rms.

EXCEPTION 2: The equipment is supplied from the

ungrounded secondary of an AC mains isolation

transformer.

R11-1.2 The GFCI, GFEPCI, RCD or ELB, when

required to satisfy Japanese requirements, should have

trip ratings of not greater than 30 mA and 0.1 second.

EXCEPTION 1: If there is no accessible live circuit

during maintenance tasks, trip ratings of up to 300 mA

are acceptable.

EXCEPTION 2: If the equipment satisfies Exception 1

and the earth impedance is less than 50 ohms, a GFCI,

GFEPCI, RCD or ELB of 500 mA maximum is

acceptable.

EXCEPTION 3: If the equipment is connected to a

source of supply that is provided with a GFCI,

GFEPCI, RCD or ELB, an additional GFCI, GFEPCI,

RCD or ELB is not required for the equipment.

R11-2 USA

R11-2.1 Nameplates — In addition to the nameplate

requirement noted in the Electrical section of S2,

equipment evaluated as “Industrial Machinery” per

NFPA 79 and intended for use in the United States may

be required to display additional nameplate

information, such as ampere rating of the largest motor

or load, short circuit interrupting capacity of the

machine overcurrent protective device where furnished

as part of the equipment, and the electrical diagram

number(s) or the number of the index to the electrical

diagrams. Furthermore, where overcurrent protection is

provided, the equipment must be marked “overcurrent

protection provided at machine supply terminals.”

R11-2.1 Hazard Communication — Federal

government OSHA regulations, found in 29 CFR

1910.1200, establish various requirements for labeling

of containers of hazardous chemicals and providing

Material Safety Data Sheets.

R11-3 Europe

R11-3.1 Nameplates — In addition to the nameplate

requirement noted in the Electrical section of S2,

equipment evaluated as “Industrial Machinery” per IEC

60204-1 (EN 60204-1) and intended for use in Europe

may be required to display additional nameplate

information, such as: certification mark, where

required; current rating of the largest motor or load;

short-circuit interrupting capacity of the machine

overcurrent protective device, where furnished as part

of the equipment; and the electrical diagram number(s)

or the number of the index to the electrical drawings.

R11-3.1.1 Where only a single motor controller is

used, this information may instead be provided on the

machine nameplate where it is plainly visible.

R11-3.1.2 The full-load current shown on the

nameplate shall be not less than the combined full-load

currents for all motors and other equipment that can be

in operation at the same time under normal conditions

of use. Where unusual loads or duty cycles require

oversized conductors, the required capacity shall be

included in the full-load current specified on the

nameplate.

R11-3.2 European Union requires compliance to CE

marking.

R11-4 Worldwide — Hazard Alert Labels

R11-4.1 USA — Labels intended for use in the USA

should conform to ANSI Z535.4.

R11-4.2 Other Countries — Labels intended for use in

countries other than the USA should conform to ISO

3864.