CE认证标准清单.doc

CE认证产品常用标准清单
一、CE认证适用得一般标准：
Serial Number/Version
Standard and Description
Scope
备注
MDD 93/42/EEC
Medical 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: 2007
Medical devices – Quality management systems – Requirements for regulatory purposes
Quality system
质量体系法规
EN ISO 14971: 2007
Medical devices – Application of risk management to medical devices
Risk Management
风险管理标准
EN 60601-1: 2006+A1:2013
Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
General requirements:
electrical safety and essential performance
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 standards: electromagnetic compatibility – Test and requirements
General requirements:
EMC
医疗电子产品并列标准：EMC
ISO 15233-1: 2012
Medical devices — Symbols to be used with medical device labels, labeling and information to be supplied — Part 1: General requirements
General requirements:
Markings Applied in Labels
医疗器械标签、作标记与提供信息得符号
EN 1041: 2008
Terminology, symbols and information provided with medical devices
General requirements:
Terminology
医疗器械常用术语、标记
EN ISO 10993-1: 2009
Biological evaluation of medical devices – Part 1: Evaluation and testing
Biological Evaluation
生物相容性标准
EN ISO 10993-5: 2009
Biological Evaluation of Medical Devices – Part 5:
Tests for In Vitro Cytotoxicity
Biological Evaluation
EN ISO 10993-10: 2010
Biological Evaluation of Medical Devices – Part 10:
Tests for Irritation and Delayed-Type Hypersensitivity
Biological Evaluation
EN 14155: 2011
Clinical 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得临床试验
MEDDEV 2、7、1
Guidelines 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/Version
Standard and Description
Scope
备注
EN 60601-1-6: 2010
Medical 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: 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
General requirements：
Alarm system
医疗电子产品并列标准：报警系统
EN 60601-2-49: 2011
Medical Electrical Equipment Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment
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
Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment
ECG monitoring:
Safety requirements
医疗电子产品专用标准：心电监护仪
EN 60601-2-30: 2009
Medical Electrical Equipment Part 2-30: Particular requirements for the safety and essential performance of automated non-invasive sphygmomanometers
Blood pressure monitoring:
Safety requirements
医疗电子产品专用标准：无创血压计
ISO 80601-2-61:
2011
Medical electrical equipment – Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment
SpO2:
Performance requirement
医疗电子产品专用标准：血氧设备
ISO 80601-2-56: 2009
Medical electrical equipment – Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement
Temperature:
Performance requirement
医疗电子产品专用标准：临床体温计
ISO 80601-2-55 : 2011
Medical electrical equipment– Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors
Respiratory 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/Version
Standard and Description
Scope
备注
IEC 60601-1-11: 2010
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
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
Medical Electrical Equipment Part 2-30: Particular requirements for the safety and essential performance of automated non-invasive sphygmomanometers
Blood pressure monitoring:
Safety requirements
医疗电子产品专用标准：无创血压计
ISO 80601-2-61:
2011
Medical electrical equipment – Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment
SpO2:
Performance requirement
医疗电子产品专用标准：血氧设备
ISO 80601-2-56: 2009
Medical electrical equipment – Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement
Temperature:
Performance requirement
医疗电子产品专用标准：临床体温计
注：生理参数检测含有得心电、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
Scope
备注
IEC 60601-1-11: 2010
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
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
Medical electrical equipment – Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment
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：
Serial Number/Version
Standard and Description
Scope
备注
IEC 60601-1-11: 2010
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
General requirements:
Home healthcare
医疗电子产品并列标准：家用健康环境
IEC 60601-2-37:
2007
Medical electrical equipment Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
Fetal monitoring: Requirements for safety and performance
医疗电子产品专用标准：超声诊断与监护设备
六、 快速心电检测仪适用标准：
Serial Number/Version
Standard and Description
Scope
备注
IEC 60601-1-11: 2010
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
General requirements:
Home healthcare
医疗电子产品并列标准：家用健康环境
备注：第一部分属于常用标准，适用于公司做过CE认证得所有医疗产品，后面就是根据产品得功能、特性附加得标准。所以一般情况下，可用第一部分加上其她部分即可组成具体产品得适用标准。