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为了共同防控新型冠状病毒肺炎疫情,经ISO、IEC授权和国家标准委批准,由国家标准技术审评中心主办的中国标准信息服务网在疫情防控期间,向中国企事业单位及个人用户免费提供相关疫情防控ISO、IEC标准全文在线阅读服务。可免费在线阅读的国际标准涉及医疗器械生物学评价、防护服、危险化学品和微生物防护手套、安全性及恢复能力、风险管理、医用电气设备等方面,共计33项,具体标准目录附后。国际标准化组织(ISO)、国际电工委员会(IEC)与国家标准委(SAC)一起,共同以实际行动支持中国企业复工复产,为打赢疫情防控阻击战贡献力量。

标准号 标准名称
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

ISO 10993-1:2018 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

ISO 13688:2013 Protective clothing – General requirements

防护服 - 一般要求

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

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

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

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

ISO 31000:2018 Risk management – Guidelines

风险管理 - 指南

ISO 10651-3:1997 Lung 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

ISO 10651-4:2002 Lung 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

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.第5部分:气动急救人工呼吸器

ISO 13485:2016 Medical 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

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

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]

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

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

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

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

ISO 19223:2019 Lung ventilators and related equipment — Vocabulary and semantics

呼吸机及相关设备 - 词汇和语义

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

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

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

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]

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 - 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

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

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

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

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

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 第1部分_基本安全和基本性能

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 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

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

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

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 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