CE认证标准清单.doc

CE认证产品常用标准清单一.CE认证适用的一般标准：Serial Number/VersionStandard and DescriptionScope备注MDD 93/42/EECMedical Device Directive (93/42/EEC) （Including Directive 2007/47/EC）EU regulation欧盟有源医疗器械指令EN ISO 13485: 2003/AC: 2007Medical devices Quality management systems Requirements for regulatory purposesQuality system质量体系法规EN ISO 14971: 2007Medical devices Application of risk management to medical devicesRisk Management风险管理标准EN 60601-1: 2006+A1:2013Medical electrical equipment Part 1: General requirements for basic safety and essential performanceGeneral requirements:electrical safety and essential performance医疗电子产品通用标准EN 60601-1-2: 2014Medical devices part 1-2: General requirements for safety and essential performance Collateral standards: electromagnetic compatibility Test and requirementsGeneral requirements:EMC医疗电子产品并列标准：EMCISO 15233-1: 2012Medical devices Symbols to be used with medical device labels, labeling and information to be supplied Part 1: General requirementsGeneral requirements:Markings Applied in Labels医疗器械标签、作标记和提供信息的符号EN 1041: 2008Terminology, symbols and information provided with medical devicesGeneral requirements:Terminology医疗器械常用术语、标记EN ISO 10993-1: 2009Biological evaluation of medical devices Part 1: Evaluation and testingBiological Evaluation生物相容性标准EN ISO 10993-5: 2009Biological Evaluation of Medical Devices Part 5:Tests for In Vitro CytotoxicityBiological EvaluationEN ISO 10993-10: 2010Biological Evaluation of Medical Devices Part 10:Tests for Irritation and Delayed-Type HypersensitivityBiological EvaluationEN 14155: 2011Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)医学研究受验者用医疗器械的临床试验MEDDEV 2.7.1Guidelines on medical devices Evaluation of clinical data: A guide for manufacturers and Notified Body医疗器械临床评价二. 监护仪系列产品适用标准：Serial Number/VersionStandard and DescriptionScope备注EN 60601-1-6: 2010Medical electrical equipment Part 1-6: General requirements for basic safety and essential performance Collateral Standard: Usability.General requirements:Usability医疗电子产品并列标准：可用性EN60601-1-8: 2007Medical 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 systemsGeneral requirements：Alarm system医疗电子产品并列标准：报警系统EN 60601-2-49: 2011Medical Electrical Equipment Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipmentGeneral requirements:Patient monitoring医疗电子产品专用标准：多参数监护仪IEC 60601-2-27: 2011Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipmentECG monitoring:Safety requirements医疗电子产品专用标准：心电监护仪EN 60601-2-30: 2009Medical Electrical Equipment Part 2-30: Particular requirements for the safety and essential performance of automated non-invasive sphygmomanometersBlood pressure monitoring:Safety requirements医疗电子产品专用标准：无创血压计ISO 80601-2-61:2011Medical electrical equipment Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipmentSpO2:Performance requirement医疗电子产品专用标准：血氧设备ISO 80601-2-56: 2009Medical electrical equipment Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurementTemperature:Performance requirement医疗电子产品专用标准：临床体温计ISO 80601-2-55 : 2011Medical electrical equipment Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitorsRespiratory gas monitoring: Safety requirements Performance requirement.医疗电子产品专用标准：呼吸气体监护设备三. 生理参数检测仪适用标准：Serial Number/VersionStandard and DescriptionScope备注IEC 60601-1-11: 2010Medical 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 environmentGeneral requirements:Home healthcare医疗电子产品并列标准：家用健康环境EN 60601-2-30: 2009Medical Electrical Equipment Part 2-30: Particular requirements for the safety and essential performance of automated non-invasive sphygmomanometersBlood pressure monitoring:Safety requirements医疗电子产品专用标准：无创血压计ISO 80601-2-61:2011Medical electrical equipment Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipmentSpO2:Performance requirement医疗电子产品专用标准：血氧设备ISO 80601-2-56: 2009Medical electrical equipment Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurementTemperature:Performance requirement医疗电子产品专用标准：临床体温计注：生理参数检测含有的心电、血糖、无线传输功能并没有随产品做CE认证。四. 血氧系列产品（含血氧探头）适用标准：Serial Number/VersionStandard and DescriptionScope备注IEC 60601-1-11: 2010Medical 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 environmentGeneral requirements:Home healthcare医疗电子产品并列标准：家用健康环境ISO 80601-2-61:2011Medical electrical equipment Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipmentSpO2:Performance requirement医疗电子产品专用标准：血氧设备注：血氧探头没有IEC 60601-1-11: 2010标准。五. 多普勒胎心仪适用标准：Serial Number/VersionStandard and DescriptionScope备注IEC 60601-1-11: 2010Medical 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 environmentGeneral requirements:Home healthcare医疗电子产品并列标准：家用健康环境IEC 60601-2-37:2007Medical electrical equipment Part 2-37: Particular requirements for the basic safety and essential performance o