CE认证标准清单

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1、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 sys

2、tem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 performanc

3、e医疗电子产品通用标准EN 6060112： 2014Medical devices part 12： 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 152331： 2012Medical devices Symbols to be used with medical device labels，

4、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 109931： 2009Biological evaluation of m

5、edical 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 1099310： 2010Biological Evaluation of Medical Devices Part 10:Tests for Irritation and Delayed-Type

6、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

7、产品适用标准：Serial Number/VersionStandard and DescriptionScope备注EN 60601-16： 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EN606011-8: 2007Medical electrical equipment P

8、art 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 606012-49: 2011Medical Electrical

9、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 227: Particular requirements for the basic safety and

10、 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 606012-30： 2009Medical Electrical Equipment Part 230: Particular requirements for the safety and essential performance of automated non-invasive sphygmomanometersBlood pressure mon

11、itoring：Safety requirements医疗电子产品专用标准：无创血压计ISO 806012-61:2011Medical 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 806012-56： 2009Medical electrical equipment Part 256: Part

12、icular 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 80601-255 ： 2011Medical electrical equipment Part 2-55： Particular requirements for the basic safety and essential performanc

13、e 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 60601-111: 2010Medical electrical equipment Part 111: General requirements for basic safety and essential per

14、formance 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 606012-30: 2009Medical Electrical Equipment Part 2-30： Particular requirements for the safety and

15、essential performance of automated noninvasive sphygmomanometersBlood pressure monitoring：Safety requirements医疗电子产品专用标准：无创血压计ISO 80601-261：2011Medical electrical equipment Part 261: Particular requirements for basic safety and essential performance of pulse oximeter equipmentSpO2:Performance require

16、ment医疗电子产品专用标准：血氧设备ISO 80601-256： 2009Medical electrical equipment Part 256: 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

17、探头）适用标准:Serial Number/VersionStandard and DescriptionScope备注IEC 60601-111： 2010Medical electrical equipment Part 111： General requirements for basic safety and essential performance Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home hea

18、lthcare 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

19、。 多普勒胎心仪适用标准：Serial Number/VersionStandard and DescriptionScope备注IEC 60601-111： 2010Medical electrical equipment Part 111: General requirements for basic safety and essential performance Collateral Standard： Requirements for medical electrical equipment and medical electrical systems used in the hom

20、e healthcare environmentGeneral requirements:Home healthcare医疗电子产品并列标准：家用健康环境IEC 60601237：2007Medical electrical equipment Part 237: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipmentFetal monitoring: Requirements for safe

21、ty and performance医疗电子产品专用标准：超声诊断和监护设备六. 快速心电检测仪适用标准：Serial Number/VersionStandard and DescriptionScope备注IEC 60601-111： 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：家用健康环境备注：第一部分属于常用标准，适用于公司做过CE认证的所有医疗产品，后面是根据产品的功能、特性附加的标准.所以一般情况下,可用第一部分加上其他部分即可组成具体产品的适用标准.4