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市场监管总局(标准委)推动33项疫情防控 国际标准免费公开

2020-04-28 13:39:13
   为充分发挥标准技术优势,助力应对全球新冠肺炎疫情,有力支持企业复工复产达产,市场监管总局(标准委)积极与国际标准化组织(ISO)、国际电工委员会(IEC)沟通联系,推动疫情防控相关国际标准免费向社会公开。在获得ISO、IEC授权同意后,市场监管总局(标准委)迅速组织在中国标准信息服务网上,免费公开了医用肺呼吸机、防护服、医疗器械生物学评价等33项疫情防控相关国际标准,为战胜疫情贡献标准力量。 
  中国是ISO、IEC的常任理事国,保护国际标准版权是我们应尽的责任和义务。为此,在公开标准的同时,我们严格遵守ISO、IEC国际标准版权政策要求,切实履行国际标准版权保护的责任和义务。 

  附:33项疫情防控国际标准清单

1 ISO 374-5:2016 Protective gloves against dangerous chemicals and micro-organisms - Part 5: Terminology and performance requirements for micro-organisms risks
危险化学品和微生物防护手套——5部分:微生物风险的术语和性能要求
2 ISO 10993-1:2018 Biological uation of medical devices – Part 1: uation and testing within a risk management process
医疗器械生物学评价——1部分:风险管理过程中的评价与试验
3 ISO 13688:2013 Protective clothing – General requirements
防护服——一般要求
4 ISO 22301:2019 Security and resilience – Business continuity management systems –Requirements
安全性及恢复能力——商业连续性管理系统——要求
5 ISO 22395:2018 Security and resilience – Community resilience – Guidelines for supporting vulnerable persons in an emergency
安全性及恢复能力——社区恢复能力——紧急情况下支持弱势人群的准则
6 ISO 22320:2018 Security and resilience – Emergency management – Guidelines for incident management
安全性及恢复能力——应急管理——事故管理指南
7 ISO 22316:2017 Security and resilience – Organizational resilience – Principles and attributes
安全性及恢复能力——组织机构恢复能力——原则和属性
8 ISO 31000:2018 Risk management – Guidelines
风险管理——指南
9 ISO 10651-3:1997 Lung ventilators for medical use — Part 3: Particular requirements for emergency and transport ventilators
医用肺呼吸机——3部分:急救和运送用呼吸机的特殊要求
10 ISO 10651-4:2002 Lung ventilators — Part 4: Particular requirements for operatorpowered resuscitators
肺呼吸机——4部分:操作员控制用人工呼吸机的特殊要求
11 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——5部分:气动急救人工呼吸器
12 ISO 13485:2016 Medical devices — Quality management systems - Requirements for regulatory purposes
医疗器械——质量管理体系——监管要求
13 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
14 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]
15 ISO 18562-1:2017 Biocompatibility uation of breathing gas pathways in healthcare applications — Part 1: uation 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——1部分风险管理过程中的评估和试验
16 ISO 18562-2:2017 Biocompatibility uation 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——2部分颗粒物排放试验
17 ISO 18562-3:2017 Biocompatibility uation 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——3部分挥发性有机化合物(VOC)排放试验
18 ISO 18562-4:2017 Biocompatibility uation 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——4部分冷凝物中的析出物试验
19 ISO 19223:2019 Lung ventilators and related equipment — Vocabulary and semantics
呼吸机及相关设备——词汇和语义
20 ISO 20395:2019 Biotechnology — Requirements for uating 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——qPCRdPCR(实时荧光定量聚合酶链式反应和数字聚合酶链式反应)
21 ISO 5356-1:2015 Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and sockets
麻醉剂和呼吸设备——锥形连接器——1部分:锥体和插孔
22 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——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
23 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——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  ISO 80601-2-13:2011/Amd.2:2018, 修订 2]
24 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——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
25 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——2-74部分呼吸加湿器基本安全和基本性能的特殊要求
26 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——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
27 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——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
28 ISO/TS 16976-8:2013 Respiratory protective devices — Human factors — Part 8: Ergonomic factors
呼吸保护装置——人为因素——8部分:人体工学因素
29 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——1部分基本安全和基本性能
30 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——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
31 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——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
32 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——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
33 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——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

信息来源:国家市场监督管理局总局
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