EMC and laser safety |
| 02-14 11:27:00 来源： 作者： |
|
EMC and laser safety Inquiry (采购产品): 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 **** Hidden Message ***** Alan Matthews 93455 Company: Den-Mat Holdings, LLC E-mail: amatthews@denmat.com **** Hidden Message ***** amatthews@denmat.com |
|
|
|
|
|
|
