CE认证适用标准清单2012

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 980:2008Symbols 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+A2:2009Non-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 methods 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+A2:20092015年实施 EN 1060-3:1997+A2:2009Non-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 10993-1:2009Biological evaluation of medical devices - Part 1: Evaluation 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/T16886.1-2001,I DT, ISO10993-1997EN 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） GB/T16886.3-2008,I DTEN 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）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 13485:2003YY/T0287- 2003, IDTEN 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---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 14971:2009YY/T0316- 2008, IDTEN ISO23747:2009Anaesthetic and respiratory equipment — Peak expiratory flow meters for the assessment of pulmonary function in Spontaneously 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 ISO23747:2007 Note 2.1 (2010.03.21)EN 60601-1:2006Medical 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 60601-1:1990 +A1:1993+A2:1995+ A13:1996EN 60601-1-1:2001 EN 60601-1-4:1996 + A1:1999(01/06/2012)EN 60601-1-2:2007Medical 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 amendment Note 2.1(01/06/2012)YY0505-2005,IDT, IEC60601-1-2:2001EN 60601-1-6:2010Medical 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 60601-1-6:2007 Note 2.1(01/04/2013)EN 60601-1-8:2007Medical electrical equipment - Part 1-8: Generalrequirements for basic safety and essential performance - EN 60601-1-8:2004 and its amendment(01/06/2012)Collateral Standard: General requirements, tests andguidance for alarm systems in medical electricalequipment and medical electrical systems (IEC60601-1-8:2006)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EN 60601-1-11:2010Medical electrical equipment -- Part 1-11: Generalrequirements for basic safety and essential performance -Collateral standard: Requirements for medical electricalequipment and medical electrical systems used in thehome 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 60601-2-2:2009Medical 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)GB9706.4-1999,IDT,IEC60601-2-2:1991EN 60601-2-24:1998Medical electrical equipment - Part 2-24: Particular requirements for the safety of infusion pumps andcontrollers (IEC 60601-2-24:1998)医疗电气设备第2-24部分输液泵和控制器的特殊安全要求NONEEN 60601-2-25:1995/ A1:1999Medical electrical equipment - Part 2-25: Particular requirements for the safety of electrocardiographs(IEC 60601-2-25:1993/A1:1999)医疗电气设备第2-25部分：对心电图仪安全性的特殊要求NONE GB10793-2000,IDT,IEC60601-2-25:1993EN 60601-2-26:2003Medical electrical equipment - Part 2-26: Particular requirements for the safety of electroencephalographs (IEC 60601-2-26:2002)医用电气设备第2-25部分：脑电描记器的特殊安全要求EN 60601-2-26:1994Note 2.1(01.03.2006)GB9706.26-2005,IDTEN 60601-2-27:2006Medical electrical equipment - Part 2-27: Particular requirements for the safety, including essential performance, of electrocardiographic monitoring equipment (IEC 60601-2-27:2005)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EN 60601-2-27:1994Note 2.1(01.11.2008)GB9706.25-2005,IDTIEC60601-2-27:1994EN 60601-2-30:2000 EN 60601-2-30:1995 YY0667-2008,IDTMedical 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Note 2.1(01.02.2003)自动循环无创血压监护设备安全和基本性能EN 60601-2-34:2000Medical electrical equipment - Part 2-34: Particular requirements for the safety, including essential performance, of invasive blood pressure monitoring equipment (IEC 60601-2-34:2000)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EN 60601-2-34:1995 Note 2.1(01.11.2003)EN 60601-2-37:2008Medical 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 60601-2-37:2001 and its amendments Note 2.1(01.10.2010)EN 60601-2-40:1998Medical electrical equipment - Part 2-40: Particular requirements for the safety of electromyographs andevoked response equipment(IEC 60601-2-40:1998)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NONEEN 60601-2-47:2001Medical electrical equipment - Part 2-47: Particular requirements for the safety, including essentialperformance, of ambulatory electrocardiographic systems(IEC 60601-2-47:2001)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)NONEEN 60601-2-49:2001Medical electrical equipment - Part 2-49: Particular requirements for the safety of multifunction patient monitoring equipment(IEC 60601-2-49:2001)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NONE YY0668-2008,IDT多参数患者监护设备安全专用要求EN 60601-2-51:2003Medical electrical equipment - Part 2-51: Particular requirements for safety, including essential performance,of recording and analysing single channel andNONEmultichannel electrocardiographs(IEC 60601-2-51:2003)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)EN 62304:2006Medical 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NONE YY/T0664- 2008,IDTEN 62366:2008Medical devices - Application of usability engineering tomedical devices (IEC 62366:2007)医疗设备-医疗设备使用性应用NONE ⅡIVD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）对应中文标准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 ISO 13485:2012 (new)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 13485:2003 YY/T0287- 2003, IDTEN 13612:2002/AC:2002Performance evaluation of in vitro diagnostic medicaldevices体外诊断设备的性能评估EN ISO 14971:2012（new）Medical devices - Application of risk management tomedical devices (ISO 14971:2007, Corrected version2007-10-1)医疗器械风险管理的应用EN ISO 14971:2009 YY/T0316- 2008, IDTEN ISO 18113-1:2011In vitro diagnostic medical devices - Informationsupplied by the manufacturer (labelling) - Part 1: Terms,definitions and general requirements (ISO18113-1:2009)体外诊断医疗器械.制造商提供的信息(标签).术语、定义和一般要求EN ISO 18113-1:2019EN ISO 18113-3:2011In vitro diagnostic medical devices - Informationsupplied by the manufacturer (labelling) - Part 3: In vitrodiagnostic instruments for professional use (ISOEN ISO 18113-3:200918113-3:2009)体外诊断医疗器械制造商提供的信息(标签) 专业用体外诊断仪器EN 61010-2-101:2002Safety requirements for electrical equipment for measurement, control, and laboratory use -- Part2-101: Particular requirements for in vitro diagnostic (IVD) medical equipmentIEC 61010-2-101:2002 (Modified)测量、控制和实验室用电气设备的安全要求.实验室诊断(IVD)医疗设备的特殊要求NONEYY0648-2008,IDTEN 61326-2-6:2006Electrical equipment for measurement, control and laboratory use - EMC requirements -- Part 2-6:Particular requirements - In vitro diagnostic (IVD) medical equipment IEC 61326-2-6:2005测量、控制和实验室用电气设备电磁兼容性要求第1部分:一般要求NONEGB/T18268.26-2010,IDTEN 62304:2006Medical device software - Software life-cycle processes(IEC 62304:2006)医疗器械用软件,软件寿命周期过程NONE YY/T0664- 2008, IDTEN 62366:2008Medical devices - Application of usability engineering tomedical devices (IEC 62366:2007)医疗设备.医疗设备可用性工程的应用NONEⅢIEC、ISO、ANSI/AAMI等国际标准（已列入欧盟协调标准的除外）IEC、ISO标准名称被替代的标准（作废日期）对应中文标准IEC 61266: 1994Ultrasonics - Hand-held probe Doppler fetal heartbeat detectors - Performance requirements and methods of measurement and reporting超声学手持式探头多普勒胎儿心率检测仪性能要求及测量和报告方法NONE IEC 61157:1992Requirements for the Declaration of the Acoustic Output of Medical Diagnostic Ultrasonic Equipment医疗诊断超声设备-声输出的要求NONEGB16846-2008, IDTANSI/AAMI SP-10:2002+A1:2003+A2:2006 Manual, electronic, or automated Sphygmomanometers手动，电子或自动血压计NONE YY0670-2008,NEQ,ANSI/AAMISP-10:2002ISO 80601-2-61：2011(new) ISO9919:2005 适用于拟申请CE认证Medical electrical equipment —Part 2-61:Particular requirements for basic safetyand essential performance of pulseoximeter equipment医用电气设备-2-61部分：脉搏血氧设备基本安全和性能的特殊要求的项目和尚未通过CE 认证的项目ISO 80601-2-55:2011 (new)specifies particular requirements for the basic safetyand essential performance of a respiratory gas monitor (RGM) intended for continuous operation for use with a patient.连续运行于患者的呼吸气体监测器的基本安全和基本性能专用要求EN ISO 21647:2004(21.03.2010)适用于拟申请CE认证的项目和尚未通过CE认证的项目EN 61010-1:2010Safety requirements for electrical equipment formeasurement, control, and laboratory use -- Part 1:General requirements IEC 61010-1:2010测量，控制和实验室用电气设备的安全要求-1部分一般要求EN 61010-1:2001EN 61326-1:2006Electrical equipment for measurement, control andlaboratory use - EMC requirements -- Part 1: Generalrequirements IEC 61326-1:2005量测，控制和实验室用电气设备-EMC要求-1部分一般要求NONEEN 61010-2-081:2002Safety requirements for electrical equipment formeasurement, control and laboratory use -- Part2-081: Particular requirements for automatic andsemi-automatic laboratory equipment for analysisand other purposes IEC 61010-2-081:2001测量，控制和实验室用电气设备的安全要求-2-081部分分析或其他用途的自动和半自动实验室设备的特殊要求NONE增加EN ISO 81060-1:2012以后将替换EN 1060-2:1995+A1:2009&EN 1060-1:1995+A2:2009；EN ISO13485&EN ISO14971进行了更新；EN ISO 14155:2011替换EN ISO14155-1&EN ISO14155-2；ISO 80601-2-61：2011替换ISO9919:2005；ISO 80601-2-55:2011替换EN ISO 21647:2004.。