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——第5部分:微生物风险的术语和性能要求

2 ISO10993-1:2018

Biological evaluation of medical devices–Part 1:Evaluation and testing within a risk management process

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

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 medicaluse—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

10 ISO 10651-4:2002

Lung ventilators—Part 4:Particular requirements for operator powered 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

11 ISO 10651-5:2006

Lung ventilators for medicaluse—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

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ISO18082:2014/Amd.1:2017,修订1]

15 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

16 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

17 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

18 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

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 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（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——第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——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

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——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]

24 ISO 80601-2-70:2015

Medical electrical equipment—Part 2-70:Particular requirements for basic safety and essential

performance of sleep apnoea breathing the rapyequipment

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

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——第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——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

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——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

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——第8部分:人体工学因素

29 IEC 60601-1:2005+AMD 1:2012 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

30 IEC 60601-1-2:2014

Medical electrical equipment-Part 1-2:General requirements for basic safety and essential performance-Collateral standard:Electromagnetic disturbances-Requirement sandtests

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

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——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

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——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

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 homehealth care 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

来源：http://www.samr.gov.cn/xw/zj/202004/t20200424_314627.html