EMC and laser safety |
| 01-11 14:13:21 来源： 作者： |
|
EMC and laser safety This is an inquiry message about EMC and laser safety in the 108th China Canton Fair. (这是一条买家关于"EMC and laser safety"的询盘信息，来自第108届中国广交会。)Inquiry Message (询盘信息) EMC and laser safety Sir/madam: I am looking for a testing service that will evaluate our medical device for conformance to IEC 60601-1-2, Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral standard: Electromagnetic Compatibility - Requirements and Tests (Edition 2:2001 with Amendment 1:2004) (AAMI/ANSI/IEC 60601-1-2:2001 with Amendment 1:2004 is the U.S. ? IEC 60601-1, Medical Electrical Equipment - Part 1: General Requirements for Safety, 1988; Amendment 1, 1991-11, Amendment 2, 1995. ? IEC 60601-1-1:2000, Medical electrical equipment -- Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems. ? IEC 60825-1 Ed. 2.0 (2007), Safety of laser products - Part 1: Equipment classification, and requirements. ?IEC 60601-2-22 (1995), Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment - Edition 2.0. (Applies to laser equipment for medical applications, classified as a class 3B or a class 4 laser product according to the classification in IEC 60825-1.) Laser Notice 50 that addressing specific 21 CFR provisions, including 21 CFR 1040.10 and 1040.11 Contact Info (联系信息) Alan Matthews 93455 Company: Den-Mat Holdings, LLC E-mail: amatthews@denmat.com amatthews@denmat.com |
|
|
|
|
|
|
