新冠肺炎疫情发生以来，经与ISO积极沟通，在获得ISO授权后，我国在网上免费公开了ISO 10993-1:2018《医疗器械生物学评价-第1部分：风险管理过程中的评价与试验》、ISO 13688:2013《防护服-一般要求》等8项疫情防控相关标准。4月7日，经ISO和IEC授权同意，我国再次免费公开了20项医用肺呼吸机等医疗器械相关ISO标准，以及5项医用电气设备IEC标准，为打赢疫情防控阻击战持续贡献标准力量。
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20项呼吸机和基本医疗器械相关ISO标准和5项医用电气设备IEC标准清单
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序号
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标准号
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标准名称（英文）
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标准名称（中文）
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1
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ISO 10651-3:1997
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Lung ventilators for medical use — Part 3: Particular requirements for emergency and transport ventilators
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医用肺呼吸机 第3部分：急救和运送用呼吸机的特殊要求
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2
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ISO 10651-4:2002
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Lung ventilators — Part 4: Particular requirements for operatorpowered resuscitators
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肺呼吸机 第4部分：操作员控制用人工呼吸机的特殊要求
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3
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ISO 10651-5:2006
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Lung ventilators for medical use — Particular requirements for basic safety and essential performance — Part 5: Gas-powered emergency resuscitators
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医用肺呼吸机 基本安全和基本性能的特殊要求.第5部分：气动急救人工呼吸器
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4
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ISO 13485:2016
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Medical devices — Quality management systems — Requirements for regulatory purposes
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医疗器械 - 质量管理体系 - 用于法规的要求
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5
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ISO 17510:2015
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Medical devices — Sleep apnoea breathing therapy — Masks and application accessories
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医疗器械 - 睡眠窒息呼吸治疗 - 面罩和应用附件
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6
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ISO 18082:2014
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Anaesthetic and respiratory equipment — Dimensions of noninterchangeable screw-threaded (NIST) low-pressure connectors for medical gases
[Including ISO 18082:2014/Amd.1:2017, AMENDMENT 1] |
麻醉剂和呼吸设备. 医疗气体用非交替式螺栓. 螺纹(NIST)低压力连接器尺寸 [包括ISO 18082:2014/Amd.1:2017, 修订 1]
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7
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ISO 18562-1:2017
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Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 1: evaluation and testing within a risk management process
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医疗保健应用中呼吸气体通道的生物相容性评估. 第1部分: 风险管理过程中的评估和试验
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8
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ISO 18562-2:2017
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Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 2: Tests for emissions of particulate matter
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医疗保健应用中呼吸气体通道的生物相容性评估. 第2部分: 颗粒物排放试验
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9
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ISO 18562-3:2017
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Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 3: Tests for emissions of volatile organic compounds (VOCs)
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医疗保健应用中呼吸气体通道的生物相容性评估. 第3部分: 挥发性有机化合物(VOC)排放试验
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10
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ISO 18562-4:2017
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Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 4: Tests for leachables in condensate
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医疗保健应用中呼吸气体通道的生物相容性评估. 第4部分: 冷凝物中的析出物试验
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11
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ISO 19223:2019
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Lung ventilators and related equipment — Vocabulary and semantics
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呼吸机及相关设备 - 词汇和语义
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12
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ISO 20395:2019
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Biotechnology — Requirements for evaluating the performance of quantification methods for nucleic acid target sequences — qPCR and dPCR
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生物技术 - 核酸目标序列量化方法性能评估要求 - qPCR和dPCR
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13
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ISO 5356-1:2015
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Anaesthetic and respiratory equipment — Conical connectors — Part1: Cones and sockets
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麻醉剂和呼吸设备 - 锥形连接器 - 第1部分: 锥体和插孔
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14
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ISO 80601-2-12:2020
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Medical electrical equipment — Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
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医用电气设备 - 第2-12部分：重症监护呼吸机基本安全和基本性能的特殊要求
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15
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ISO 80601-2-13:2011
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Medical electrical equipment — Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation
[Including: ISO 80601-2-13:2011/Amd.1:2015, AMENDMENT 1 and ISO 80601-2-13:2011/Amd.2:2018, AMENDMENT 2] |
医疗电气设备 - 第2-13部分: 麻醉工作站的基本安全和基本性能的特殊要求
[包括 ISO 80601-2-13:2011/Amd.1:2015, 修订 1 和 ISO 80601-2- 13:2011/Amd.2:2018, 修订 2] |
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16
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ISO 80601-2-70:2015
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Medical electrical equipment — Part 2-70: Particular requirements for basic safety and essential performance of sleep apnoea breathing therapy equipment
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医疗电气设备 - 第2-70部分：睡眠窒息呼吸治疗设备的基本安全和基本性能的特殊要求
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17
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ISO 80601-2-74:2017
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Medical electrical equipment — Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment
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医疗电气设备 - 第2-74部分: 呼吸加湿器基本安全和基本性能的特殊要求
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18
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ISO 80601-2-79:2018
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Medical electrical equipment — Part 2-79: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory impairment
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医疗电气设备 - 第2-79部分：呼吸受损的呼吸支持设备基本安全和基本性能的特殊要求
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19
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ISO 80601-2-80:2018
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Medical electrical equipment — Part 2-80: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory insufficiency
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医疗电气设备 - 第2-80部分：呼吸功能不全的呼吸支持设备基本安全和基本性能的特殊要求
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20
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ISO/TS 16976-8:2013
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Respiratory protective devices — Human factors — Part 8:Ergonomic factors
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呼吸保护装置 - 人为因素 - 第8部分:人体工学因素
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21
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IEC 60601-1:2005+AMD1:2012 CSV
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Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
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医用电气设备 第1部分_基本安全和基本性能
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22
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IEC 60601-1-2:2014
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Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests
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医用电气设备 第1-2部分：基本安全和基本性能的通用要求 汇编标准：电磁干扰-要求和测试
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23
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IEC 60601-1-6:2010
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Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
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医用电气设备 第1-6部分：基本安全性和必要性能的通用要求 汇编标准:可用性
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24
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IEC 60601-1-8:2006
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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
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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 汇编标准：医疗电气设备和医疗电气系统报警系统的通用要求、试验和指南
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25
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IEC 60601-1-11:2015
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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
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医疗电气设备 第1-11部分：基本安全和基本性能的通用要求 汇编标准：家庭保健用医疗电气设备和医疗电气系统的要求
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