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 |
近日，国际标准化组织（ISO）正式发布了由我国牵头制定的两项制冷压缩机国际标准《容积式制冷压缩机性能评价》《离心式制冷压缩机性能评价》，填补了该领域国际标准空白，标志着全球制冷压缩机产业迈入规范化、标......
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......
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......
近日，我国自主研发的面向工厂自动化应用的高速现场无线网络技术规范(WIA-FA)正式成为国际电工委员会(IEC)标准(IEC62948)，标志着我国自主研发的工业自动化无线网络技术已得到国际自动化领域......