医疗器械CE认证标准清单
医疗器械CE认证标准清单 I MDD指令(93/42/EEC)欧盟协调标准 协调标准名称(参考文件) 被替代的标准 (作废日期) 对应中文标准 EN 980:2008 Symbols for use in the labelling of medical devices 医疗器械标签用图形符号 EN 980:2003 (31/05/2010) EN 1041:2008 Ination supplied by the manufacturer with medical devices 医疗产品生产者提供的信息 EN 1041:1998 (31/08/2011) EN 1060-1:1995+A2:2009 Non-invasive sphygmomanometers - Part 1: General requirements 非侵入式血压计.第1部分:一般要求.修改件A1 — EN ISO 81060-1:2012 (new) Non-invasive sphygmomanometers - Part 1: Requirements and test s for non-automated measurement type (ISO 81060-1:2007) 非侵入式血压计.第1部分:非自动量测型的一般 要求及测试方法 EN 1060-2:1995+A1:2009 EN 1060-1:1995+A2:2009 2015年实施 EN 1060-3:1997+A2:2009 Non-invasive sphygmomanometers - Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems 非侵入式血压表.第3部分:电机血压表的补充要 求 EN 1060-3:1997 (31/05/2010) EN ISO 10993-1:2009 Biological uation of medical devices - Part 1: uation and testing (ISO 10993-1:2009) 医疗器械的生物学评价第1部分:评价和试验 EN ISO 10993-1:2003 (21/03/2010) GB/T16886. 1-200 1, IDT, IS010993-1997 EN ISO 10993-3:2009 Biological uation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2003) 医疗器械的生物学评价 第3部分:遗传毒性,致癌 性毒性和生殖毒性试验 EN ISO 10993-3:2003 (21/03/2010) GB/T16886. 3-200 8, IDT EN 12470-4:2000+Al:2009 Clinical thermometers 一 Part 4: Perance of electrical thermometers for continuous measurement 临床温度计 第4部分:用于连续测量的电子温度 计的性能 EN 12470-4:2000 (21/03/2010) EN ISO 13485:2012 (new) Medical devices - Quality management systems -Requirements for regulatory purposes (ISO 13485:2003) 医疗设备.质量管理体系.管理要求 EN ISO 13485:2003 YY/T0287- 2003, IDT EN ISO 14155:2011(new) Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011) 实验于人体的医疗器械临床研究一-有效的临床实 践 EN ISO 14155-1:2009&EN ISO 14155-2:2009 (03/04/2012) EN ISO 14971:2012 (new) Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-1) 医疗器械风险管理的应用 EN ISO 14971:2009 YY/T0316- 2008, IDT EN IS023747:2009 Anaesthetic and respiratory equipment 一 Peak expiratory flow meters for the assessment of pulmonary function in Spontaneously breathing humans (IS023747:2007) 麻醉和呼吸设备.自然呼吸者肺功能评估用呼气峰 值流量计 EN IS023747: 2007 Note 2. 1 (2010. 03. 21) EN 60601-1:2006 Medical electrical equipment - Part 1: General requirements for basic safety and essential perance (IEC 60601-1:2005) 医疗电气设备.基本安全和主要性能的一般要求 EN 60601-1:1990 +A1:1993+A2:1995+ A13:1996 EN 60601-1-1:2001 EN 60601-1-4:1996 + Al:1999 (01/06/2012) EN 60601-1-2:2007 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential perance - Collateral standard: Electromagnetic compatibility - Requirements and tests (IEC 60601-1-2:2007 (Modified)) 医疗电气设备第1-2部分:对安全性的一般要 求电磁兼容性要求和试验 EN 60601-1-2:2001 and its amendment Note 2. 1 (01/06/2012) YY05