速览！20项医用肺呼吸机等医疗器械相关ISO标准公开
4月7日，经ISO和IEC授权同意，我国免费公开了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。
| 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 | |||
| 序号 | 标准号 | 标准名称（英文） | 标准名称（中文） |
| 1 | ISO 10651-3:1997 | Lung ventilators for medical use — Part 3: Particular requirements for emergency and transport ventilators | 医用肺呼吸机 第3部分：急救和运送用呼吸机的特殊要求 |
| 2 | ISO 10651-4:2002 | Lung ventilators — Part 4: Particular requirements for operatorpowered resuscitators | 肺呼吸机 第4部分：操作员控制用人工呼吸机的特殊要求 |
| 3 | ISO 10651-5:2006 | Lung ventilators for medical use — Particular requirements for basic safety and essential performance — Part 5: Gas-powered emergency resuscitators | 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 |
| 4 | ISO 13485:2016 | Medical devices — Quality management systems — Requirements for regulatory purposes | 医疗器械 - 质量管理体系 - 用于法规的要求 |
| 5 | ISO 17510:2015 | Medical devices — Sleep apnoea breathing therapy — Masks and application accessories | 医疗器械 - 睡眠窒息呼吸治疗 - 面罩和应用附件 |
| 6 | ISO 18082:2014 | 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] |
| 7 | ISO 18562-1:2017 | Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 1: Evaluation and testing within a risk management process | 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 |
| 8 | ISO 18562-2:2017 | Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 2: Tests for emissions of particulate matter | 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 |
| 9 | ISO 18562-3:2017 | Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 3: Tests for emissions of volatile organic compounds (VOCs) | 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 |
| 10 | ISO 18562-4:2017 | Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 4: Tests for leachables in condensate | 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 |
| 11 | ISO 19223:2019 | Lung ventilators and related equipment — Vocabulary and semantics | 呼吸机及相关设备 - 词汇和语义 |
| 12 | ISO 20395:2019 | Biotechnology — Requirements for evaluating the performance of quantification methods for nucleic acid target sequences — qPCR and dPCR | 生物技术 - 核酸目标序列量化方法性能评估要求 - qPCR和dPCR |
| 13 | ISO 5356-1:2015 | Anaesthetic and respiratory equipment — Conical connectors — Part1: Cones and sockets | 麻醉剂和呼吸设备 - 锥形连接器 - 第1部分: 锥体和插孔 |
| 14 | ISO 80601-2-12:2020 | Medical electrical equipment — Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators | 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 |
| 15 | ISO 80601-2-13:2011 | 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] |
| 16 | ISO 80601-2-70:2015 | Medical electrical equipment — Part 2-70: Particular requirements for basic safety and essential performance of sleep apnoea breathing therapy equipment | 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 |
| 17 | ISO 80601-2-74:2017 | Medical electrical equipment — Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment | 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 |
| 18 | ISO 80601-2-79:2018 | Medical electrical equipment — Part 2-79: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory impairment | 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 |
| 19 | ISO 80601-2-80:2018 | Medical electrical equipment — Part 2-80: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory insufficiency | 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 |
| 20 | ISO/TS 16976-8:2013 | Respiratory protective devices — Human factors — Part 8:Ergonomic factors | 呼吸保护装置 - 人为因素 - 第8部分:人体工学因素 |
| 21 | IEC 60601-1:2005+AMD1:2012 CSV | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance | 医用电气设备 第1部分_基本安全和基本性能 |
| 22 | IEC 60601-1-2:2014 | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests | 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 |
| 23 | IEC 60601-1-6:2010 | Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability | 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 |
| 24 | IEC 60601-1-8:2006 | 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 | 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 |
| 25 | IEC 60601-1-11:2015 | 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 | 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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