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来源: 发布时间：2020-04-26
| 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 |
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 |
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 |
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 |
| 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 |