速覽！20項醫用肺呼吸機等醫療器械相關ISO標準公開
4月7日，經ISO和IEC授權同意，我國免費公開了20項醫用肺呼吸機等醫療器械相關ISO標準，以及5項醫用電氣設備IEC標準，為打贏疫情防控阻擊戰持續貢獻標準力量。
| 20項呼吸機和基本醫療器械相關ISO標準和5項醫用電氣設備IEC標準清單 | |||
| 序號 | 標準號 | 標準名稱（英文） | 標準名稱（中文） |
| 1 | ISO 10651-3:1997 | Lung ventilators ? for medical use — Part 3: Particular requirements for emergency and transport ? ventilators | 醫用肺呼吸機 第3部分：急救和運送用呼吸機的特殊要求 |
| 2 | ISO 10651-4:2002 | Lung ventilators — Part 4: Particular requirements for operatorpowered resuscitators | 肺呼吸機 第4部分：操作員控制用人工呼吸機的特殊要求 |
| 3 | ISO 10651-5:2006 | Lung ventilators ? for medical use — Particular requirements for basic safety and essential ? performance — Part 5: Gas-powered emergency resuscitators | 醫用肺呼吸機 基本安全和基本性能的特殊要求.第5部分：氣動急救人工呼吸器 |
| 4 | ISO 13485:2016 | Medical devices — Quality management systems — Requirements ? for regulatory purposes | 醫療器械 - 質量管理體系 - 用于法規的要求 |
| 5 | ISO 17510:2015 | Medical devices — Sleep apnoea breathing therapy — Masks ? and application accessories | 醫療器械 - 睡眠窒息呼吸治療 - 面罩和應用附件 |
| 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] | 麻醉劑和呼吸設備. 醫療氣體用非交替式螺栓. 螺紋(NIST)低壓力連接器尺寸 [包括ISO 18082:2014/Amd.1:2017, 修訂 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 | 醫療保健應用中呼吸氣體通道的生物相容性評估. 第1部分: 風險管理過程中的評估和試驗 |
| 8 | ISO 18562-2:2017 | Biocompatibility ? evaluation of breathing gas pathways in healthcare applications — Part 2: Tests for emissions of particulate matter | 醫療保健應用中呼吸氣體通道的生物相容性評估. 第2部分: 顆粒物排放試驗 |
| 9 | ISO 18562-3:2017 | Biocompatibility ? evaluation of breathing gas pathways in healthcare applications — Part 3: Tests for emissions of volatile organic compounds (VOCs) | 醫療保健應用中呼吸氣體通道的生物相容性評估. 第3部分: 揮發性有機化合物(VOC)排放試驗 |
| 10 | ISO 18562-4:2017 | Biocompatibility ? evaluation of breathing gas pathways in healthcare applications — Part 4: Tests for leachables in condensate | 醫療保健應用中呼吸氣體通道的生物相容性評估. 第4部分: 冷凝物中的析出物試驗 |
| 11 | ISO 19223:2019 | Lung ventilators ? and related equipment — Vocabulary and semantics | 呼吸機及相關設備 - 詞匯和語義 |
| 12 | ISO 20395:2019 | Biotechnology — Requirements for evaluating the performance of quantification ? methods for nucleic acid target sequences — qPCR and ? dPCR | 生物技術 - 核酸目標序列量化方法性能評估要求 - qPCR和dPCR |
| 13 | ISO 5356-1:2015 | Anaesthetic and ? respiratory equipment — Conical connectors — Part1: ? Cones and sockets | 麻醉劑和呼吸設備 - 錐形連接器 - 第1部分: 錐體和插孔 |
| 14 | ISO ? 80601-2-12:2020 | Medical ? electrical equipment — Part 2-12: Particular requirements for basic safety ? and essential performance of critical care ventilators | 醫用電氣設備 - 第2-12部分：重癥監護呼吸機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] | 醫療電氣設備 - 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, 修訂 1 和 ISO 80601-2- ? 13:2011/Amd.2:2018, 修訂 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 | 醫療電氣設備 - 第2-70部分：睡眠窒息呼吸治療設備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 | 醫療電氣設備 - 第2-74部分: 呼吸加濕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 | 醫療電氣設備 - 第2-79部分：呼吸受損的呼吸支持設備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 | 醫療電氣設備 - 第2-80部分：呼吸功能不全的呼吸支持設備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 | 呼吸保護裝置 - 人為因素 - 第8部分:人體工學因素 |
| 21 | IEC ? 60601-1:2005+AMD1:2012 CSV | Medical ? electrical equipment - Part 1: General requirements for basic safety and ? essential performance | 醫用電氣設備 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 | 醫用電氣設備 第1-2部分：基本安全和基本性能的通用要求 匯編標準：電磁干擾-要求和測試 |
| 23 | IEC ? 60601-1-6:2010 | Medical ? electrical equipment - Part 1-6: General requirements for basic safety and ? essential performance - Collateral standard: Usability | 醫用電氣設備 第1-6部分：基本安全性和必要性能的通用要求 匯編標準: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 | 醫用電氣設備 第1-8部分：基本安全和基本性能的通用要求 匯編標準：醫療電氣設備和醫療電氣系統報警系統的通用要求、試驗和指南 |
| 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 | 醫療電氣設備 第1-11部分：基本安全和基本性能的通用要求 匯編標準：家庭保健用醫療電氣設備和醫療電氣系統的要求 |
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