新冠肺炎疫情發(fā)生以來，經(jīng)與ISO積極溝通，在獲得ISO授權(quán)后，我國在網(wǎng)上免費公開了ISO 10993-1:2018《醫(yī)療器械生物學評價-第1部分：風險管理過程中的評價與試驗》、ISO 13688:2013《防護服-一般要求》等8項疫情防控相關(guān)標準。4月7日，經(jīng)ISO和IEC授權(quán)同意，我國再次免費公開了20項醫(yī)用肺呼吸機等醫(yī)療器械相關(guān)ISO標準，以及5項醫(yī)用電氣設(shè)備IEC標準，為打贏疫情防控阻擊戰(zhàn)持續(xù)貢獻標準力量。
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20項呼吸機和基本醫(yī)療器械相關(guān)ISO標準和5項醫(yī)用電氣設(shè)備IEC標準清單
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序號
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標準號
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標準名稱（英文）
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標準名稱（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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醫(yī)用肺呼吸機 第3部分：急救和運送用呼吸機的特殊要求
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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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肺呼吸機 第4部分：操作員控制用人工呼吸機的特殊要求
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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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醫(yī)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
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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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醫(yī)療器械 - 質(zhì)量管理體系 - 用于法規(guī)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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醫(yī)療器械 - 睡眠窒息呼吸治療 - 面罩和應用附件
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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] |
麻醉劑和呼吸設(shè)備. 醫(yī)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]
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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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醫(yī)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
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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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醫(yī)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
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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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醫(yī)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(fā)性有機化合物(VOC)排放試驗
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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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醫(yī)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
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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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呼吸機及相關(guān)設(shè)備 - 詞匯和語義
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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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生物技術(shù) - 核酸目標序列量化方法性能評估要求 - 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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麻醉劑和呼吸設(shè)備 - 錐形連接器 - 第1部分: 錐體和插孔
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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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醫(yī)用電氣設(shè)備 - 第2-12部分：重癥監(jiān)護呼吸機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] |
醫(yī)療電氣設(shè)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] |
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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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醫(yī)療電氣設(shè)備 - 第2-70部分：睡眠窒息呼吸治療設(shè)備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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醫(yī)療電氣設(shè)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
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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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醫(yī)療電氣設(shè)備 - 第2-79部分：呼吸受損的呼吸支持設(shè)備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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醫(yī)療電氣設(shè)備 - 第2-80部分：呼吸功能不全的呼吸支持設(shè)備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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呼吸保護裝置 - 人為因素 - 第8部分:人體工學因素
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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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醫(yī)用電氣設(shè)備 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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醫(yī)用電氣設(shè)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
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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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醫(yī)用電氣設(shè)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
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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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醫(yī)用電氣設(shè)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(yī)療電氣設(shè)備和醫(yī)療電氣系統(tǒng)報警系統(tǒng)的通用要求、試驗和指南
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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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醫(yī)療電氣設(shè)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(yī)療電氣設(shè)備和醫(yī)療電氣系統(tǒng)的要求
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