CE认证适用标准清单.doc

CE认证适用标准清单 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）TRF版本EN 980:2008Symbols 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 1041:2008Information 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A12002A, 1.07.09EN 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)2005A, 1.07.09EN ISO 9919:2009Medical electrical equipment - Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use (ISO 9919:2005)医用电气设备.医用脉动式血氧计的基本安全和性能的特殊要求EN ISO 9919:2005 （21/03/2010）2005A, 1.07.09EN ISO 10993-1:2009Biological evaluation of medical devices - Part 1: Evaluation and testing (ISO 10993-1:2009)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）EN ISO 10993-1:2009/AC:2010 (new)First publicationEN ISO 10993-3:2009Biological evaluation 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）EN 12470-4:2000+A1:2009Clinical thermometers - Part 4: Performance 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）2000A, 01.07.09EN ISO 13485:2003/AC:2009 Medical devices - Quality management systems - Requirements for regulatory purposes医疗设备.质量管理体系.管理要求EN ISO 14155-1:2009 Clinical investigation of medical devices for human subjects - Part 1: General requirements (ISO 14155-1:2003)人用医疗设备的临床调查.一般要求EN ISO14155-1:1993(21.03.2010)EN ISO 14155-2:2009 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003)医学研究受验者用医疗器械的临床调查.临床调查计规划EN ISO14155-2:1993(21.03.2010)EN ISO 14971:2009 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 14971:2007(21.03.2010)EN ISO 21647:2009Medical electrical equipment - Particular requirements for the basic safety and essential performance of respiratory gas monitors (ISO 21647:2004, including Cor 1:2005)医疗电气设备.呼吸气监测器的基本安全和主要性能的特殊要求EN ISO 21647:2004(21.03.2010)EN ISO23747:2009 Anaesthetic and respiratory equipment Peak expiratory flow meters for the assessment of pulmonary function inSpontaneously breathing humans(ISO23747:2007)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 ISO23747:2007Note 2.1(2010.03.21)EN 60601-1:1990+ A1:1993+ A2:1995Medical electrical equipment - Part 1: General requirements for safety (IEC 60601-1:1988/A1:1991/A2:1995)医疗电气设备.安全的一般要求NONEEN 60601-1:2006 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (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 60601-1:1990and its amendments+EN60601-1-1:2001+EN60601-1-4:1996 and its amendments(01/06/2012)EN 60601-1:2006/AC:2010 (new) first publicationEN 60601-1-1:2001 Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems (IEC 60601-1-1:2000)医用电气设备.安全性的一般要求.副标准.医用电气设备的安全要求EN 60601-1-1:1993+ A1:1996Note 2.1(01.11.2003)2000A,17.07.09EN 60601-1-2:2007 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - 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 60601-1-2:2001and its amendmentNote 2.1(01/06/2012)EN 60601-1-2:2007/AC:2010 (new)first publicationEN 60601-1-4:1996 +A1:1999Medical electrical equipment - Part 1-4: General requirements for safety - Collateral standard: Programmable electrical medical systems (IEC 60601-1-4:1996/A1:1999) 医院电气设备.安全的一般要求.副标准.可编程的医院电气设备的一般要求NONE1999A,17.07.09EN 60601-1-6:2007 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral Standard: Usability (IEC 60601-1-6:2006)医疗电气设备.第1-6部分：对安全性的一般要求.附属标准:使用性EN 60601-1-6:2004Note 2.1(01/06/2012)2006A,17.07.09EN 60601-1-6:2007/AC:2010 (new)first publicationEN 60601-1-6:2010 (new)Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral Standard: Usability (IEC 60601-1-6:2010)医疗电气设备.第1-6部分：对安全性的一般要求.附属标准:使用性EN 60601-1-6:2007Note 2.1(01/04/2013)2006A,17.07.09EN 60601-1-8:2007 Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems 医疗电气设备.第1-8部分：对基本安全和主要性能的一般要求.附属标准:对医疗电器设备及医疗电器系统报警系统的测试和指导的一般要求，(IEC 60601-1-8:2006)EN 60601-1-8:2004and its amendment(01/06/2012)2006A,07.07.09EN 60601-1-8:2007/AC:2010 (new)first publicationEN 60601-1-11:2010 (new)Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environmentIEC 60601-1-11:2010医用电气设备 - 第1-11：基本安全和基本性能的通用要求 相关标准：医用电气设备和家庭医疗保健环境中使用的医疗电气系统需求first publicationEN 60601-2-2:2009 Medical electrical equipment - Part 2-2: Particular requirements for the safety of high frequency surgical equipment (IEC 60601-2-2:2009)医疗电气设备第2-2部分：对高频外科设备的特殊安全要求EN 60601-2-2:2007Note 2.1(01.04.2012)EN 60601-2-24:1998 Medical electrical equipment - Part 2-24: Particular requirements for the safety of infusion pumps and controllers 医疗电气设备第2-2部分.输液泵和控制器的特殊安全要求(IEC 60601-2-24:1998)NONEEN 60601-2-25:1995/ A1:1999Medical electrical equipment - Part 2-25: Particular requirements for the safety of electrocardiographs 医疗电气设备第2-25部分：对心电图仪安全性的特殊要求(IEC 60601-2-25:1993/A1:1999)NONEEN 60601-2-26:2003 Medical electrical equipment - Part 2-26: Particular requirements for the safety of electroencephalographs 医用电气设备第2-25部分：脑电描记器的特殊安全要求(IEC 60601-2-26:2002)EN 60601-2-26:1994Note 2.1(01.03.2006)2002A,23.07.09EN 60601-2-27:2006 Medical electrical equipment - Part 2-27: Particular requirements for the safety, including essential performance, of electrocardiographic monitoring equipment医疗电气设备第2-27部分：对心电图描记监视设备安全性的特殊要求(IEC 60601-2-27:2005)EN 60601-2-27:1994Note 2.1(01.11.2008)2005A,1.07.09EN 60601-2-27:2006/AC:2006 (new)First publicationEN 60601-2-30:2000 Medical electrical equipment - Part 2-30: Particular requirements for the safety, including essential performance, of automatic cycling non-invasive blood pressure monitoring equipment (IEC 60601-2-30:1999)医疗电气设备第2-30部分：对自动循环血压间接监视设备安全性的特殊要求EN 60601-2-30:1995Note 2.1(01.02.2003)1999A,1.06.09EN 60601-2-34:2000 Medical electrical equipment - Part 2-34: Particular requirements for the safety, including essential performance, of invasive blood pressure monitoring equipment 医疗电气设备第2-34部分：对直接式血压监视设备安全性的特殊要求(IEC 60601-2-34:2000) EN 60601-2-34:1995Note 2.1(01.11.2003)2000A,1.07.09EN 60601-2-37:2008 Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment (IEC 60601-2-37:2007)医疗电气设备第2-37部分.超声医疗诊断和监测设备安全的特殊要求EN 60601-2-37:2001and its amendmentsNote 2.1(01.10.2010)EN 60601-2-40:1998 Medical electrical equipment - Part 2-40: Particular requirements for the safety of electromyographs and evoked response equipment 医疗电气设备第2-40部分:电子肌动描记器及诱发反应设备安全性的特殊要求(IEC 60601-2-40:1998)NONEEN 60601-2-47:2001 Medical electrical equipment - Part 2-47: Particular requirements for the safety, including essential performance, of ambulatory electrocardiographic systems (IEC 60601-2-47:2001) 动态心电图系统医用电气设备第2-47部分.流动心电图测试系统的特定安全要求(包括基本性能)NONE2001A,2.09.09EN 60601-2-49:2001 Medical electrical equipment - Part 2-49: Particular requirements for the safety of multifunction patient monitoring equipment 医疗电气设备第2-49部分.多功能病人监测设备的特殊安全要求(IEC 60601-2-49:2001)NONE2001A,1.07.09EN 60601-2-51:2003 Medical electrical equipment - Part 2-51: Particular requirements for safety, including essential performance, of recording and analysing single channel and multichannel electrocardiographs 医疗电气设备.记录和分析单道和多道心电描记器的特殊安全性要求(包括主要性能)(IEC 60601-2-51:2003)NONEEN 62304:2006 Medical device software - Software life-cycle processes (IEC 62304:2006)医疗设备软件-软件生命周期循环过程NONE2006A,1.06.09EN 62304:2006/AC:2008 (new)First publicationEN 62366:2008 Medical devices - Application of usability engineering to medical devices 医疗设备-医疗设备使用性应用(IEC 62366:2007)NONE IVD指令（98/79/EC）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）TRF版本EN 13612:2002/AC:2002Performance evaluation of in vitro diagnostic medical devicesEN ISO 18113-1:2009 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009)EN ISO 18113-3:2009 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2009