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25项疫情防控相关ISO和IEC标准可免费在线阅读!
发布时间:2020-06-10 15:03:25 来源: 作者: 浏览次数:61

新冠肺炎疫情发生以来,经与ISO积极沟通,在获得ISO授权后,我国在中国标准信息服务网上免费公开了ISO 10993-1:2018《医疗器械生物学评价-第1部分:风险管理过程中的评价与试验》、ISO 13688:2013《防护服-一般要求》等8项疫情防控相关标准,为中国用户提供免费在线阅读服务。4月7日,经ISO和IEC授权同意,我国再次在标准信息服务网免费公开了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。

      欲免费在线阅读以下标准,请登录https://www.sacinfo.cn/isoOpen
 

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)
1ISO 10651-3:1997Lung 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
2ISO 10651-4:2002Lung 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
3ISO 10651-5:2006Lung 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
4ISO 13485:2016Medical 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
5ISO 17510:2015Medical 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
6ISO 18082:2014Anaesthetic 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]
7ISO 18562-1:2017Biocompatibility   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
8ISO 18562-2:2017Biocompatibility   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
9ISO 18562-3:2017Biocompatibility   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
10ISO 18562-4:2017Biocompatibility   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
11ISO 19223:2019Lung ventilators   and related equipment — Vocabulary and semantics呼吸机及相关设备 - 词汇和语义
12ISO 20395:2019Biotechnology — 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
13ISO 5356-1:2015Anaesthetic 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
14ISO   80601-2-12:2020Medical   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
15ISO   80601-2-13:2011Medical   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]
16ISO   80601-2-70:2015Medical   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
17ISO   80601-2-74:2017Medical   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
18ISO   80601-2-79:2018Medical   electrical equipment — Part 2-79: Particular requirements for basic safety   and essential performance of ventilatorysupport 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
19ISO   80601-2-80:2018Medical   electrical equipment — Part 2-80: Particular requirements for basic safety   and essential performance of ventilatorysupport 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
20ISO/TS   16976-8:2013Respiratory   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
21IEC   60601-1:2005+AMD1:2012 CSVMedical   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
22IEC   60601-1-2:2014Medical   electrical equipment - Part 1-2: General requirementsfor 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
23IEC   60601-1-6:2010Medical   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
24IEC   60601-1-8:2006Medical   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
25IEC   60601-1-11:2015Medical   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