医疗器械CE认证.ppt

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1、CE认证认证中国企业进入欧盟市场的必中国企业进入欧盟市场的必由之路由之路CE标志与欧盟标志与欧盟 部分已颁布部分已颁布CE指令指令符合符合CE指令的指令的5个关键性步骤个关键性步骤 医疗器械产品医疗器械产品CE-MDD 93/42/EEC指令指令 电磁兼容性的保护要求电磁兼容性的保护要求 符合性评鉴符合性评鉴 电磁兼容性的测试标准电磁兼容性的测试标准 European Standardisation OrganisationReference and title of the standard Reference documentReference of the superseded stan

2、dardDate of cessation of presumption of conformity of the superseded standardNote 1CENELECEN 60601-1-1:2001 Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systemsIEC 60601-1-1:2000EN 60601-1-1:1993+A1:1996Not

3、e 2.1Date expired (01.12.2003)CENELECEN 60601-1-2:1993 Medical electrical equipment - Part 1: General requirements for safety - 2. Collateral standard: Electromagnetic compatibility - Requirements and testsIEC 60601-1-2:1993NONE-CENELECEN 60601-1-2:2001 Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and testsIEC 60601-1-2:2001EN 60601-1-2:1993Note 2.101.11.2004总结总结