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医疗器械检验

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标准列表（第 92 / 97 页）

IEC60601-2-22:2007 医疗电气设备 - 第2-22部分:手术化妆品治疗和诊断激光设备的基本安全和基本性能的特殊要求Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment

IEC60601-2-21:2020/AMD1:2023 修改件1.医用电气设备.第2-21部分:婴儿辐射加热器的基本安全和基本性能的特殊要求Amendment 1 - Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers

IEC60601-2-20:2020/AMD1:2023 修改件1.医用电气设备.第2-20部分:婴儿运输保温箱的基本安全和基本性能的特殊要求Amendment 1 - Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators

IEC60601-2-2:2017+Amd1:2023 医用电气设备第2-2部分:高频手术设备及高频附件的基本安全和基本性能专用要求 Medical electrical equipment-Part 2-2:Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories

IEC60601-2-2:2017 医用电气设备第2-2部分:高频手术设备和高频手术附件的基本安全和基本性能的特殊要求Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories

IEC60601-2-19:2020/AMD1:2023 修改件1-医用电气设��-第2-19部分:婴儿保育箱基本安全和基本性能的特殊要求Amendment 1 - Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators

IEC60601-2-18:2009 医用电气设备第2-18部分:内窥镜设备的基本安全和基本性能专用要求 Medical electrical equipment- Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment

IEC60601-2-16:2025 医用电气设备第2-16部分:血液透析､血液透析滤过和血液滤过设备的基本安全和基本性能专用要求 Medical electrical equipment-Part 2-16:Particular requirements for the basic safety and essential performance of haemodialysis,haemodiafiltration and haemodiafiltrationequipment

IEC60601-2-16:2018 医疗电气设备 - 第2-16部分:血液透析血液过滤和除血设备基本安全和基本性能的特殊要求Medical electrical equipment - Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment

废止，仅限能力项目库范围内现行有效产品标准引用本标准及监督抽检时申请...

IEC60601-2-11:2013 医疗电气设备 - 第2-11部分:伽马射线治疗设备的基本安全和基本性能的特殊要求Medical electrical equipment - Part 2-11: Particular requirements for the basic safety and essential performance of gamma beam therapy equipment

IEC60601-2-10:2012+AMD1:2016CSV 医用电气设备第2-10部分:特殊要求确保神经和肌肉的基本安全和基本性能刺激器Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators

IEC60601-2-10:2012+AMD1:2016+AMD2:2023CSV 医用电气设备.第2-10部分:神经和肌肉刺激器基本安全和基本性能的特殊要求Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators

IEC60601-2-10:2012+Amd1:2016+Amd2:2023 医用电气设备第2-10部分:神经和肌肉刺激器的基本安全和基本性能专用要求 Medical electrical equipment-Part 2-10:Particular requirements for the basic safety and essential performance of nerve and muscle stimulators

IEC60601-2-10:2012/AMD2:2023 修改件2.医用电气设备.第2-10部分:神经和肌肉刺激器基本安全和基本性能的特殊要求Amendment 2 - Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators

IEC60601-2-10:2012/AMD1:2016 修改件1.医用电气设备.第2-10部分:神经和肌肉刺激器基本安全和基本性能的特殊要求Amendment 1 - Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators

IEC60601-2-10:2012 医疗电气设备第2-10部分:神经和肌肉刺激器的基本安全和基本性能的特殊要求Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators

IEC60601-1-8:2006+AMD1:2012CSV 医用电气设备第1-8部分:一般要求基本安全和基本性能-附带标准: 工业用报警系统的一般要求､试验和指南医用电气设备和医用电气系统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

IEC60601-1-8:2006+AMD1:2012+AMD2:2020CSV 医用电气设备.第1-8部分:基本安全和基本性能的一般要求.并列标准:医用电气设备和医用电气系统中报警系统的一般要求､试验和指南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

IEC60601-1-8:2006+AMD1:2012+AMD2:2020 医用电气设备第1-8部分:基本安全和基本性能的通用要求并列标准:通用要求,医用电气设备和医用电气系统中报警系统的测试和指南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

IEC60601-1-8:2006/AMD2:2020 修改件2.医用电气设备.第1-8部分:基本安全和基本性能的一般要求.附带标准:医用电气设备和医用电气系统报警系统的一般要求试验和指南Amendment 2 - 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

IEC60601-1-8:2006/AMD1:2012 修改件1.医用电气设备.第1-8部分:基本安全和基本性能的一般要求.附带标准:医用电气设备和医用电气系统报警系统的一般要求试验和指南Amendment 1 - 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

IEC60601-1-8:2006 医疗电气设备 - 第1-8部分:基本安全和基本性能的一般要求 - 抵押标准:医疗电气设备和医疗电气系统中的报警系统的一般要求测试和指导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

IEC60601-1-8:2003 医用电气设备第1-8部分:安全通用要求附属标准:医用电气设备和医用电气系统报警系统的通用要求､试验和指南Medical electrical equipment - Part 1-8: General requirements for safety - Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems

废止，仅限能力项目库范围内现行有效产品标准引用本标准及监督抽检时申请...

IEC60601-1-6:2010+Amd1:2013+Amd2:2020 医用电气设备第1-6部分:基本安全和必要性能通用要求-并列标准:可用性 Medical electrical equipment-Part 1-6:General requirements for basic safety and essential performance-Collateral standard:Usability

IEC60601-1-6:2010/AMD1:2013 修改件1.医用电气设备.第1-6部分:基本安全和基本性能的一般要求.附带标准:可用性Amendment 1 - Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability

IEC60601-1-3:2008+AMD1:2013CSV 医用电气设备第1-3部分:一般要求基本安全和基本��能-附带标准: 诊断X射线设备的辐射防护Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment

IEC60601-1-3:2008+AMD1:2013+AMD2:2021CSV 医用电气设备.第1-3部分:基本安全和基本性能的一般要求.并列标准:诊断X射线设备的辐射防护Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment

IEC60601-1-3:2008/AMD2:2021 修改件2.医用电气设备.第1-3部分:基本安全和基本性能的一般要求.附带标准:诊断X射线设备中的辐射防护Amendment 2 - Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment

IEC60601-1-3:2008/AMD1:2013 修改件1.医用电气设备.第1-3部分:基本安全和基本性能的一般要求.附带标准:诊断X射线设备中的辐射防护Amendment 1 - Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment

IEC60601-1-3:2008 医疗电气设备 - 第1-3部分:基本安全和基本性能的一般要求 - 附带标准:诊断X射线设备中的辐射防护Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment

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