CE認證標準清單--精選文檔

1、CE認證產品常用標準清單一.CE認證適用的一般標準：Serial Number/VersionStandard and DescriptionScope備注MDD 93/42/EECMedical Device Directive (93/42/EEC) （Including Directive 2007/47/EC）EU regulation歐盟有源醫(yī)療器械指令EN ISO 13485: 2003/AC: 2007Medical devices Quality management systems Requirements for regulatory purposesQuality sys

2、tem質量體系法規(guī)EN ISO 14971: 2007Medical devices Application of risk management to medical devicesRisk Management風險管理標準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醫(yī)療電子產品通用標準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醫(yī)療電子產品并列標準：EMCISO 15233-1: 2012Medical devices Symbols to be used with medical device labe

4、ls, labeling and information to be supplied Part 1: General requirementsGeneral requirements:Markings Applied in Labels醫(yī)療器械標簽、作標記和提供信息的符號EN 1041: 2008Terminology, symbols and information provided with medical devicesGeneral requirements:Terminology醫(yī)療器械常用術語、標記EN ISO 10993-1: 2009Biological evaluation

5、 of medical devices Part 1: Evaluation and testingBiological Evaluation生物相容性標準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

6、-Type HypersensitivityBiological EvaluationEN 14155: 2011Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)醫(yī)學研究受驗者用醫(yī)療器械的臨床試驗MEDDEV 2.7.1Guidelines on medical devices Evaluation of clinical data: A guide for manufacturers and Notified Body醫(yī)療器械臨床評價二.

7、 監(jiān)護儀系列產品適用標準：Serial Number/VersionStandard and DescriptionScope備注EN 60601-1-6: 2010Medical electrical equipment Part 1-6: General requirements for basic safety and essential performance Collateral Standard: Usability.General requirements:Usability醫(yī)療電子產品并列標準：可用性EN60601-1-8: 2007Medical electrical equ

8、ipment 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醫(yī)療電子產品并列標準：報警系統EN 60601-2-49: 2011Medical El

9、ectrical Equipment Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipmentGeneral requirements:Patient monitoring醫(yī)療電子產品專用標準：多參數監(jiān)護儀IEC 60601-2-27: 2011Medical electrical equipment - Part 2-27: Particular requirements for the basi

10、c safety and essential performance of electrocardiographic monitoring equipmentECG monitoring:Safety requirements醫(yī)療電子產品專用標準：心電監(jiān)護儀EN 60601-2-30: 2009Medical Electrical Equipment Part 2-30: Particular requirements for the safety and essential performance of automated non-invasive sphygmomanometersBloo

11、d pressure monitoring:Safety requirements醫(yī)療電子產品專用標準：無創(chuàng)血壓計ISO 80601-2-61:2011Medical electrical equipment Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipmentSpO2:Performance requirement醫(yī)療電子產品專用標準：血氧設備ISO 80601-2-56: 2009Medical electrical equipmen

12、t Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurementTemperature:Performance requirement醫(yī)療電子產品專用標準：臨床體溫計ISO 80601-2-55 : 2011Medical electrical equipment Part 2-55: Particular requirements for the basic safety and es

13、sential performance of respiratory gas monitorsRespiratory gas monitoring: Safety requirements Performance requirement.醫(yī)療電子產品專用標準：呼吸氣體監(jiān)護設備三. 生理參數檢測儀適用標準：Serial Number/VersionStandard and DescriptionScope備注IEC 60601-1-11: 2010Medical electrical equipment Part 1-11: General requirements for basic safe

14、ty and essential performance Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environmentGeneral requirements:Home healthcare醫(yī)療電子產品并列標準：家用健康環(huán)境EN 60601-2-30: 2009Medical Electrical Equipment Part 2-30: Particular requirement

15、s for the safety and essential performance of automated non-invasive sphygmomanometersBlood pressure monitoring:Safety requirements醫(yī)療電子產品專用標準：無創(chuàng)血壓計ISO 80601-2-61:2011Medical electrical equipment Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment

16、SpO2:Performance requirement醫(yī)療電子產品專用標準：血氧設備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醫(yī)療電子產品專用標準：臨床體溫計注：生理參數檢測含有的心電、血糖、無線傳輸功

17、能并沒有隨產品做CE認證。四. 血氧系列產品（含血氧探頭）適用標準：Serial Number/VersionStandard and DescriptionScope備注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

18、systems used in the home healthcare environmentGeneral requirements:Home healthcare醫(yī)療電子產品并列標準：家用健康環(huán)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醫(yī)療電子產品專用標準：血氧設備注：血氧

19、探頭沒有IEC 60601-1-11: 2010標準。五. 多普勒胎心儀適用標準：Serial Number/VersionStandard and DescriptionScope備注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醫(yī)療電子產品并列標準：家用健康環(huán)境IEC 60601-2-37:2007Medical electrical equipment Part 2-37: Particular requirem