CE认证产品常用标准清单
一.CE认证适用的一般标准：
Serial Number/Version MDD 93/42/EEC EN ISO 13485: 2003/AC: 2007 EN ISO 14971: 2007 EN 60601-1: 2006+A1:2013 Standard and Description Medical Device Directive (93/42/EEC) （Including Directive 2007/47/EC） Medical devices – Quality management systems – Requirements for regulatory purposes Medical devices – Application of risk management to medical devices Medical electrical equipment – Part 1: General requirements for basic safety and essential performance Scope EU regulation 备注 欧盟有源医疗器械指令 质量体系法规 Quality system Risk Management General requirements: electrical safety and essential performance 风险管理标准 医疗电子产品通用标准 EN 60601-1-2: 2014 Medical devices part 1-2: General requirements for safety and essential performance– Collateral General requirements: standards: electromagnetic compatibility – Test EMC and requirements Medical devices — Symbols to be used with General requirements: medical device labels, labeling and information Markings Applied in to be supplied — Part 1: General requirements Labels Terminology, symbols and information provided with medical devices Biological evaluation of medical devices – Part 1: Evaluation and testing Biological Evaluation of Medical Devices – Part 5: Tests for In Vitro Cytotoxicity General requirements: Terminology Biological Evaluation 医疗电子产品并列标准：EMC ISO 15233-1: 2012 EN 1041: 2008 EN ISO 10993-1: 2009 EN ISO 10993-5: 2009 医疗器械标签、作标记和提供信息的符号 医疗器械常用术语、标记 Biological Evaluation 生物相容性标准 Biological Evaluation of Medical Devices – EN ISO 10993-10: Part 10: 2010 Tests for Irritation and Delayed-Type Hypersensitivity EN 14155: 2011 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011) Guidelines on medical devices Evaluation of clinical data: A guide for manufacturers and Notified Body Biological Evaluation 医学研究受验者用医疗器械的临床试验 MEDDEV 2.7.1 医疗器械临床评价 二. 监护仪系列产品适用标准：
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Serial Number/Version EN 60601-1-6: 2010 Standard and Description Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral Standard: Usability. 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 Medical Electrical Equipment Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment Medical Electrical Equipment Part 2-30: Particular requirements for the safety and essential performance of automated non-invasive sphygmomanometers Medical electrical equipment – Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment Medical electrical equipment – Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement Medical electrical equipment– Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors Scope 备注 General requirements: Usability 医疗电子产品并列标准：可用性 EN60601-1-8: 2007 General requirements： 医疗电子产品并列标Alarm system 准：报警系统 EN 60601-2-49: 2011 General requirements: Patient monitoring 医疗电子产品专用标准：多参数监护仪 IEC 60601-2-27: 2011 ECG monitoring: Safety requirements 医疗电子产品专用标准：心电监护仪 EN 60601-2-30: 2009 Blood pressure monitoring: Safety requirements SpO2: Performance requirement Temperature: Performance requirement Respiratory gas monitoring: Safety requirements Performance requirement. 医疗电子产品专用标准：无创血压计 ISO 80601-2-61: 2011 医疗电子产品专用标准：血氧设备 ISO 80601-2-56: 2009 医疗电子产品专用标准：临床体温计 ISO 80601-2-55 : 2011 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：
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Serial Number/Version Standard and Description 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 environment Medical Electrical Equipment Part 2-30: Particular requirements for the safety and essential performance of automated non-invasive sphygmomanometers Medical electrical equipment – Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment Medical electrical equipment – Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement Scope 备注 IEC 60601-1-11: 2010 General requirements: Home healthcare 医疗电子产品并列标准：家用健康环境 EN 60601-2-30: 2009 Blood pressure monitoring: Safety requirements SpO2: Performance requirement Temperature: Performance requirement 医疗电子产品专用标准：无创血压计 ISO 80601-2-61: 2011 医疗电子产品专用标准：血氧设备 ISO 80601-2-56: 2009 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/Version Standard and Description 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 environment Medical electrical equipment – Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment Scope 备注 IEC 60601-1-11: 2010 General requirements: Home healthcare 医疗电子产品并列标准：家用健康环境 ISO 80601-2-61: 2011 SpO2: 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：
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