To support global effort in dealing with COVID-19 crisis, International Organization for Standardization (ISO), coordinated with the International Electrotechnical Commission (IEC), is providing free access to some ISO standards related to medical devices and personal care equipment.

The standards provided by ISO for free reading include:

ISO 374-5:2016 Protective gloves against dangerous chemicals and micro-organisms – Part 5: Terminology and performance requirements for micro-organisms risk
ISO 10651-3:1997 Lung ventilators for medical use — Part 3: Particular requirements for emergency and transport ventilators
ISO 10651-4:2002 Lung ventilators — Part 4: Particular requirements for operator-powered resuscitators
ISO 10651-5:2006 Lung ventilators for medical use — Particular requirements for basic safety and essential performance — Part 5: Gas-powered emergency resuscitators
ISO 10993-1:2018 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process
ISO 13485:2016 Medical devices — Quality management systems – Requirements for regulatory purposes
ISO 13688:2013 Protective clothing – General requirements
ISO 17510:2015 Medical devices — Sleep apnoea breathing therapy — Masks and application accessories
ISO 18082:2014 Anaesthetic and respiratory equipment — Dimensions of non-interchangeable screw-threaded (NIST) low-pressure connectors for medical gases
ISO 18562-1:2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 1: Evaluation and testing within a risk management process
ISO 18562-2:2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 2: Tests for emissions of particulate matter
ISO 18562-3:2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 3: Tests for emissions of volatile organic compounds (VOCs)
ISO 18562-4:2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 4: Tests for leachables in condensate
ISO 19223:2019 Lung ventilators and related equipment — Vocabulary and semantics
ISO 20395:2019 Biotechnology — Requirements for evaluating the performance of quantification methods for nucleic acid target sequences — qPCR and dPCR
ISO 22301:2019 Security and resilience – Business continuity management systems –Requirements
ISO 22395:2018 Security and resilience – Community resilience – Guidelines for supporting vulnerable persons in an emergency
ISO 22320:2018 Security and resilience – Emergency management – Guidelines for incident management
ISO 22316:2017 Security and resilience – Organizational resilience – Principles and attributes
ISO 31000:2018 Risk management – Guidelines
ISO 5356-1:2015 Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and sockets
ISO 80601-2-12:2020 Medical electrical equipment — Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
ISO 80601-2-13:2011 Medical electrical equipment — Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation
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
ISO 80601-2-74:2017 Medical electrical equipment — Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment
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
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
ISO/TS 16976-8:2013 Respiratory protective devices — Human factors — Part 8: Ergonomic factors

The button with link to these free standards is provided by DQS Academy at the end of this webpage: https://www.dqs.hk/training/schedule/. The free access is supposed to be ceased by ISO in certain time.

About ISO

ISO was founded in 1947. It is an independent, non-governmental international organization with a membership of 164 national standards bodies. ISO is now the world’s largest developer of voluntary international standards and it facilitates world trade by providing common standards among nations. By 2019, ISO has published over 20,000 international standards.

As one of the primary shareholders of DQS, DIN is one of the members of ISO, with contribution to the draft of a large number of standards.

 

免費的醫療器械和個人防護設備 ISO標準

為了協助應對全球的COVID-19疫情, 國際標準組織(ISO)協同國際電工委員會(IEC)現免費提供與醫療器械和個人防護用品相關的ISO標準。具體清單請參考以上清單。

DQS 學堂 在後列網頁的末尾提供獲得這些免費標準的鏈接: https://www.dqs.hk/training/schedule/。估計ISO會在一定的時間內終止此免費查看服務。

 

關於 國際標準組織 (ISO)

ISO成立於1947年,是一個獨立的、非政府的國際組織,目前已有164個國家的標準機構加入ISO成為其會員。它是目前國際上最大的標準化機構,通過制定共同的標準促進了全球貿易。截至2019年,ISO已經發佈了超過2萬份國際標準。

作爲 DQS 的主要股東之一的 德國標準化學會 (DIN) 是 ISO 的會員之一,並參與了多個標準的起草。

 

Ref Source: ISO website.