{"id":11748,"date":"2020-04-14T08:05:10","date_gmt":"2020-04-14T08:05:10","guid":{"rendered":"https:\/\/multiacademstg.wpengine.com\/13485academy\/?p=11748"},"modified":"2024-10-21T21:33:14","modified_gmt":"2024-10-21T21:33:14","slug":"free-access-to-iso-13485","status":"publish","type":"post","link":"https:\/\/staging.advisera.com\/13485academy\/blog\/2020\/04\/14\/free-access-to-iso-13485\/","title":{"rendered":"ISO enabled free access to ISO 13485 and other medical device and protective clothing standards"},"content":{"rendered":"<p>To support the initiatives dealing with the impact of COVID-19, the International Organization for Standardization (ISO) has made some of its standards supporting the biological evaluation of medical devices and protective clothing used in health care settings accessible for free.<\/p>\n<p>These free ISO standards are not available for free download in PDF, but they can be accessed in read-only text format from the official ISO website. For example, the ISO 13485:2016 standard in PDF format is not available for free download &#8211; you can <a href=\"https:\/\/www.iso.org\/obp\/ui#iso:std:iso:13485:ed-3:v1:en\" target=\"_blank\" rel=\"noopener\">access ISO 13485 in read-only (text) format for free<\/a> or, if needed, <a href=\"https:\/\/www.iso.org\/standard\/59752.html\" target=\"_blank\" rel=\"noopener\">purchase the ISO 13485 PDF<\/a> on the ISO website.<br \/>\n<div id=\"middle-banner\" class=\"banner-shortcode\"><\/div><script>loadMiddleBanner();<\/script><br \/>\n<div id=\"side-banner-trigger\" class=\"banner-shortcode\"><\/div><br \/>\nThe following ISO standards are available in read-only text format:<\/p>\n<ul>\n<li><a title=\"ISO 13485:2016\" href=\"https:\/\/www.iso.org\/obp\/ui#iso:std:iso:13485:ed-3:v1:en\" target=\"_blank\" rel=\"noopener noreferrer\">ISO 13485:2016<\/a>\u00a0Medical devices \u2014 Quality management systems &#8211; Requirements for regulatory purposes<\/li>\n<li><a title=\"ISO 374-5:2016\" href=\"https:\/\/www.iso.org\/obp\/ui#iso:std:iso:374:-5:ed-1:v1:en\" target=\"_blank\" rel=\"noopener noreferrer\">ISO 374-5:2016<\/a>\u00a0Protective gloves against dangerous chemicals and micro-organisms \u2013 Part 5: Terminology and performance requirements for micro-organisms risk<\/li>\n<li><a title=\"ISO 10651-3:1997\" href=\"https:\/\/www.iso.org\/obp\/ui#iso:std:iso:10651:-3:ed-1:v1:en\" target=\"_blank\" rel=\"noopener noreferrer\">ISO 10651-3:1997<\/a> Lung ventilators for medical use \u2014 Part 3: Particular requirements for emergency and transport ventilators<\/li>\n<li><a title=\"ISO 10651-4:2002\" href=\"https:\/\/www.iso.org\/obp\/ui#iso:std:iso:10651:-4:ed-1:v1:en\" target=\"_blank\" rel=\"noopener noreferrer\">ISO 10651-4:2002<\/a> Lung ventilators \u2014 Part 4: Particular requirements for operator-powered resuscitators<\/li>\n<li><a title=\"ISO 10651-5:2006\" href=\"https:\/\/www.iso.org\/obp\/ui#iso:std:iso:10651:-5:ed-1:v1:en\" target=\"_blank\" rel=\"noopener noreferrer\">ISO 10651-5:2006<\/a> Lung ventilators for medical use \u2014 Particular requirements for basic safety and essential performance \u2014 Part 5: Gas-powered emergency resuscitators<\/li>\n<li><a title=\"ISO 10993-1:2018\" href=\"https:\/\/www.iso.org\/obp\/ui#iso:std:iso:10993:-1:ed-5:v2:en\" target=\"_blank\" rel=\"noopener noreferrer\">ISO 10993-1:2018<\/a> Biological evaluation of medical devices \u2013 Part 1: Evaluation and testing within a risk management process<\/li>\n<li><a title=\"ISO 13688:2013\" href=\"https:\/\/www.iso.org\/obp\/ui#iso:std:iso:13688:ed-2:v1:en\" target=\"_blank\" rel=\"noopener noreferrer\">ISO 13688:2013<\/a> Protective clothing \u2013 General requirements<\/li>\n<li><a title=\"ISO 17510:2015\" href=\"https:\/\/www.iso.org\/obp\/ui#iso:std:iso:17510:ed-1:v1:en\" target=\"_blank\" rel=\"noopener noreferrer\">ISO 17510:2015<\/a> Medical devices \u2014 Sleep apnoea breathing therapy \u2014 Masks and application accessories<\/li>\n<li><a title=\"ISO 18082:2014\" href=\"https:\/\/www.iso.org\/obp\/ui#iso:std:iso:18082:ed-1:v1:en\" target=\"_blank\" rel=\"noopener noreferrer\">ISO 18082:2014<\/a> Anaesthetic and respiratory equipment \u2014 Dimensions of non-interchangeable screw-threaded (NIST) low-pressure connectors for medical gases (Including ISO 18082:2014\/AMD 1:2017, <a title=\"AMENDMENT 1\" href=\"https:\/\/www.iso.org\/obp\/ui#iso:std:iso:18082:ed-1:v1:amd:1:v1:en\" target=\"_blank\" rel=\"noopener noreferrer\">AMENDMENT 1<\/a>)<\/li>\n<li><a title=\"ISO 18562-1:2017\" href=\"https:\/\/www.iso.org\/obp\/ui#iso:std:iso:18562:-1:ed-1:v1:en\" target=\"_blank\" rel=\"noopener noreferrer\">ISO 18562-1:2017<\/a> Biocompatibility evaluation of breathing gas pathways in healthcare applications \u2014 Part 1: Evaluation and testing within a risk management process<\/li>\n<li><a title=\"ISO 18562-2:2017\" href=\"https:\/\/www.iso.org\/obp\/ui#iso:std:iso:18562:-2:ed-1:v1:en\" target=\"_blank\" rel=\"noopener noreferrer\">ISO 18562-2:2017<\/a> Biocompatibility evaluation of breathing gas pathways in healthcare applications \u2014 Part 2: Tests for emissions of particulate matter<\/li>\n<li><a title=\"ISO 18562-3:2017\" href=\"https:\/\/www.iso.org\/obp\/ui#iso:std:iso:18562:-3:ed-1:v1:en\" target=\"_blank\" rel=\"noopener noreferrer\">ISO 18562-3:2017<\/a> Biocompatibility evaluation of breathing gas pathways in healthcare applications \u2014 Part 3: Tests for emissions of volatile organic compounds (VOCs)<\/li>\n<li><a title=\"ISO 18562-4:2017\" href=\"https:\/\/www.iso.org\/obp\/ui#iso:std:iso:18562:-4:ed-1:v1:en\" target=\"_blank\" rel=\"noopener noreferrer\">ISO 18562-4:2017<\/a> Biocompatibility evaluation of breathing gas pathways in healthcare applications \u2014 Part 4: Tests for leachables in condensate<\/li>\n<li><a title=\"ISO 19223:2019\" href=\"https:\/\/www.iso.org\/obp\/ui#iso:std:iso:19223:ed-1:v1:en\" target=\"_blank\" rel=\"noopener noreferrer\">ISO 19223:2019<\/a> Lung ventilators and related equipment \u2014 Vocabulary and semantics<\/li>\n<li><a title=\"ISO 20395:2019\" href=\"https:\/\/www.iso.org\/obp\/ui#iso:std:iso:20395:ed-1:v1:en\" target=\"_blank\" rel=\"noopener noreferrer\">ISO 20395:2019<\/a> Biotechnology \u2014 Requirements for evaluating the performance of quantification methods for nucleic acid target sequences \u2014 qPCR and dPCR<\/li>\n<li><a title=\"ISO 5356-1:2015\" href=\"https:\/\/www.iso.org\/obp\/ui#iso:std:iso:5356:-1:ed-4:v1:en\" target=\"_blank\" rel=\"noopener noreferrer\">ISO 5356-1:2015<\/a> Anaesthetic and respiratory equipment \u2014 Conical connectors \u2014 Part 1: Cones and sockets<\/li>\n<li><a title=\"ISO 80601-2-12:2020\" href=\"https:\/\/www.iso.org\/obp\/ui#iso:std:iso:80601:-2-12:ed-2:v1:en\" target=\"_blank\" rel=\"noopener noreferrer\">ISO 80601-2-12:2020<\/a> Medical electrical equipment \u2014 Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators<\/li>\n<li><a title=\"ISO 80601-2-13:2011\" href=\"https:\/\/www.iso.org\/obp\/ui#iso:std:iso:80601:-2-13:ed-1:v1:en\" target=\"_blank\" rel=\"noopener noreferrer\">ISO 80601-2-13:2011<\/a> Medical electrical equipment \u2014 Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation (Including: ISO 80601-2-13:2011\/Amd.1:2015, <a title=\"AMENDMENT 1\" href=\"https:\/\/www.iso.org\/obp\/ui#iso:std:iso:80601:-2-13:ed-1:v1:amd:1:v1:en\" target=\"_blank\" rel=\"noopener noreferrer\">AMENDMENT 1<\/a> and ISO 80601-2-13:2011\/Amd.2:2018, <a title=\"AMENDMENT 2\" href=\"https:\/\/www.iso.org\/obp\/ui#iso:std:iso:80601:-2-13:ed-1:v1:amd:2:v1:en\" target=\"_blank\" rel=\"noopener noreferrer\">AMENDMENT 2<\/a>)<\/li>\n<li><a title=\"ISO 80601-2-70:2015\" href=\"https:\/\/www.iso.org\/obp\/ui#iso:std:iso:80601:-2-70:ed-1:v1:en\" target=\"_blank\" rel=\"noopener noreferrer\">ISO 80601-2-70:2015<\/a> Medical electrical equipment \u2014 Part 2-70: Particular requirements for basic safety and essential performance of sleep apnoea breathing therapy equipment<\/li>\n<li><a title=\"ISO 80601-2-74:2017\" href=\"https:\/\/www.iso.org\/obp\/ui#iso:std:iso:80601:-2-74:ed-1:v1:en\" target=\"_blank\" rel=\"noopener noreferrer\">ISO 80601-2-74:2017<\/a> Medical electrical equipment \u2014 Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment<\/li>\n<li><a title=\"ISO 80601-2-79:2018\" href=\"https:\/\/www.iso.org\/obp\/ui#iso:std:iso:80601:-2-79:ed-1:v1:en\" target=\"_blank\" rel=\"noopener noreferrer\">ISO 80601-2-79:2018<\/a> Medical electrical equipment \u2014 Part 2-79: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory impairment<\/li>\n<li><a title=\"ISO 80601-2-80:2018\" href=\"https:\/\/www.iso.org\/obp\/ui#iso:std:iso:80601:-2-80:ed-1:v1:en\" target=\"_blank\" rel=\"noopener noreferrer\">ISO 80601-2-80:2018<\/a> Medical electrical equipment \u2014 Part 2-80: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory insufficiency<\/li>\n<li><a title=\"ISO\/TS 16976-8:2013\" href=\"https:\/\/www.iso.org\/obp\/ui#iso:std:iso:ts:16976:-8:ed-1:v1:en\" target=\"_blank\" rel=\"noopener noreferrer\">ISO\/TS 16976-8:2013<\/a> Respiratory protective devices \u2014 Human factors \u2014 Part 8: Ergonomic factors<\/li>\n<\/ul>\n<p style=\"padding-top: 15px; padding-bottom: 10px;\"><img decoding=\"async\" class=\"aligncenter size-full wp-image-11751\" src=\"\/wp-content\/uploads\/\/sites\/14\/2020\/04\/free-download-of-iso-13485-and-other-medical-device-standards-article.png\" alt=\"ISO enabled free access to ISO 13485 and other medical device and protective clothing standards\" width=\"1000\" height=\"434\" srcset=\"\/wp-content\/uploads\/sites\/14\/2020\/04\/free-download-of-iso-13485-and-other-medical-device-standards-article.png 1000w, \/wp-content\/uploads\/sites\/14\/2020\/04\/free-download-of-iso-13485-and-other-medical-device-standards-article-300x130.png 300w, \/wp-content\/uploads\/sites\/14\/2020\/04\/free-download-of-iso-13485-and-other-medical-device-standards-article-768x333.png 768w\" sizes=\"(max-width: 1000px) 100vw, 1000px\" \/><\/p>\n<p><em>To implement ISO 13485 easily and efficiently, use our <\/em><a href=\"https:\/\/staging.advisera.com\/13485academy\/iso-13485-documentation-toolkit\/\" target=\"_blank\" rel=\"noopener\">ISO 13485 Documentation Toolkit<\/a> <em>that provides step-by-step guidance and all documents for full ISO 13485 compliance.<\/em><\/p>\n","protected":false},"excerpt":{"rendered":"<p>To support the initiatives dealing with the impact of COVID-19, the International Organization for Standardization (ISO) has made some of its standards supporting the biological evaluation of medical devices and protective clothing used in health care settings accessible for free. These free ISO standards are not available for free download in PDF, but they can &#8230;<\/p>\n","protected":false},"author":120,"featured_media":13312,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[1],"tags":[172,872,873],"class_list":["post-11748","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-blog","tag-iso-13485","tag-standards-supporting-biological-evaluation-of-medical-devices","tag-standards-supporting-protective-clothing-used-in-health-care-settings"],"acf":[],"_links":{"self":[{"href":"https:\/\/staging.advisera.com\/13485academy\/wp-json\/wp\/v2\/posts\/11748","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/staging.advisera.com\/13485academy\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/staging.advisera.com\/13485academy\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/staging.advisera.com\/13485academy\/wp-json\/wp\/v2\/users\/120"}],"replies":[{"embeddable":true,"href":"https:\/\/staging.advisera.com\/13485academy\/wp-json\/wp\/v2\/comments?post=11748"}],"version-history":[{"count":0,"href":"https:\/\/staging.advisera.com\/13485academy\/wp-json\/wp\/v2\/posts\/11748\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/staging.advisera.com\/13485academy\/wp-json\/wp\/v2\/media\/13312"}],"wp:attachment":[{"href":"https:\/\/staging.advisera.com\/13485academy\/wp-json\/wp\/v2\/media?parent=11748"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/staging.advisera.com\/13485academy\/wp-json\/wp\/v2\/categories?post=11748"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/staging.advisera.com\/13485academy\/wp-json\/wp\/v2\/tags?post=11748"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}