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data-event-name="pinnable-header.vector-toc.pin">move to sidebar</button> <button class="vector-pinnable-header-toggle-button vector-pinnable-header-unpin-button" data-event-name="pinnable-header.vector-toc.unpin">hide</button> </div> <ul class="vector-toc-contents" id="mw-panel-toc-list"> <li id="toc-mw-content-text" class="vector-toc-list-item vector-toc-level-1"> <a href="#" class="vector-toc-link"> <div class="vector-toc-text">(Top)</div> </a> </li> <li id="toc-Background" class="vector-toc-list-item vector-toc-level-1 vector-toc-list-item-expanded"> <a class="vector-toc-link" href="#Background"> <div class="vector-toc-text"> <span class="vector-toc-numb">1</span> <span>Background</span> </div> </a> <ul id="toc-Background-sublist" class="vector-toc-list"> </ul> </li> <li id="toc-Guidance_Documents" class="vector-toc-list-item vector-toc-level-1 vector-toc-list-item-expanded"> <a class="vector-toc-link" href="#Guidance_Documents"> <div class="vector-toc-text"> <span class="vector-toc-numb">2</span> <span>Guidance Documents</span> </div> </a> <ul id="toc-Guidance_Documents-sublist" class="vector-toc-list"> </ul> </li> <li id="toc-ISO_14971_risk_management_options" class="vector-toc-list-item vector-toc-level-1 vector-toc-list-item-expanded"> <a class="vector-toc-link" href="#ISO_14971_risk_management_options"> <div class="vector-toc-text"> <span class="vector-toc-numb">3</span> <span>ISO 14971 risk management options</span> </div> </a> <button aria-controls="toc-ISO_14971_risk_management_options-sublist" class="cdx-button cdx-button--weight-quiet cdx-button--icon-only vector-toc-toggle"> <span class="vector-icon mw-ui-icon-wikimedia-expand"></span> <span>Toggle ISO 14971 risk management options subsection</span> </button> <ul id="toc-ISO_14971_risk_management_options-sublist" class="vector-toc-list"> <li id="toc-Inherent_safety_by_design" class="vector-toc-list-item vector-toc-level-2"> <a class="vector-toc-link" href="#Inherent_safety_by_design"> <div class="vector-toc-text"> <span class="vector-toc-numb">3.1</span> <span>Inherent safety by design</span> </div> </a> <ul id="toc-Inherent_safety_by_design-sublist" class="vector-toc-list"> </ul> </li> <li id="toc-Protective_measures_in_the_medical_device_itself_or_in_the_manufacturing_process" class="vector-toc-list-item vector-toc-level-2"> <a class="vector-toc-link" href="#Protective_measures_in_the_medical_device_itself_or_in_the_manufacturing_process"> <div class="vector-toc-text"> <span class="vector-toc-numb">3.2</span> <span>Protective measures in the medical device itself or in the manufacturing process</span> </div> </a> <ul id="toc-Protective_measures_in_the_medical_device_itself_or_in_the_manufacturing_process-sublist" class="vector-toc-list"> </ul> </li> <li id="toc-Information_for_safety" class="vector-toc-list-item vector-toc-level-2"> <a class="vector-toc-link" href="#Information_for_safety"> <div class="vector-toc-text"> <span class="vector-toc-numb">3.3</span> <span>Information for safety</span> </div> </a> <ul id="toc-Information_for_safety-sublist" class="vector-toc-list"> </ul> </li> </ul> </li> <li id="toc-Changes_in_the_ISO_14971:2019_edition" class="vector-toc-list-item vector-toc-level-1 vector-toc-list-item-expanded"> <a class="vector-toc-link" href="#Changes_in_the_ISO_14971:2019_edition"> <div class="vector-toc-text"> <span class="vector-toc-numb">4</span> <span>Changes in the ISO 14971:2019 edition</span> </div> </a> <ul id="toc-Changes_in_the_ISO_14971:2019_edition-sublist" class="vector-toc-list"> </ul> </li> <li id="toc-History" class="vector-toc-list-item vector-toc-level-1 vector-toc-list-item-expanded"> <a class="vector-toc-link" href="#History"> <div class="vector-toc-text"> <span class="vector-toc-numb">5</span> <span>History</span> </div> </a> <ul id="toc-History-sublist" class="vector-toc-list"> </ul> </li> <li id="toc-See_also" class="vector-toc-list-item vector-toc-level-1 vector-toc-list-item-expanded"> <a class="vector-toc-link" href="#See_also"> <div class="vector-toc-text"> <span class="vector-toc-numb">6</span> <span>See also</span> </div> </a> <ul id="toc-See_also-sublist" class="vector-toc-list"> </ul> </li> <li id="toc-References" class="vector-toc-list-item vector-toc-level-1 vector-toc-list-item-expanded"> <a class="vector-toc-link" href="#References"> <div class="vector-toc-text"> <span class="vector-toc-numb">7</span> <span>References</span> </div> </a> <ul id="toc-References-sublist" class="vector-toc-list"> </ul> </li> <li id="toc-External_links" class="vector-toc-list-item vector-toc-level-1 vector-toc-list-item-expanded"> <a class="vector-toc-link" href="#External_links"> <div class="vector-toc-text"> <span class="vector-toc-numb">8</span> <span>External links</span> </div> </a> <ul id="toc-External_links-sublist" class="vector-toc-list"> </ul> </li> </ul> </div> </div> </nav> </div> </div> <div class="mw-content-container"> <main id="content" class="mw-body"> <header 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dir="ltr"><div class="shortdescription nomobile noexcerpt noprint searchaux" style="display:none">ISO standard</div> <p><b>ISO 14971</b> <i>Medical devices — Application of risk management to medical devices</i> is a voluntary consensus standard,<sup id="cite_ref-1" class="reference"><a href="#cite_note-1"><span class="cite-bracket">[</span>1<span class="cite-bracket">]</span></a></sup> published by <a href="/wiki/International_Organization_for_Standardization" title="International Organization for Standardization">International Organization for Standardization</a> (ISO) for the first time in 1998, and specifies terminology, principles, and a process for <a href="/wiki/Risk_management" title="Risk management">risk management</a> of <a href="/wiki/Medical_device" title="Medical device">medical devices</a>.<sup id="cite_ref-2" class="reference"><a href="#cite_note-2"><span class="cite-bracket">[</span>2<span class="cite-bracket">]</span></a></sup> </p><p>The current ISO 14971 edition was published in December 2019. </p> <meta property="mw:PageProp/toc" /> <div class="mw-heading mw-heading2"><h2 id="Background">Background</h2><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=ISO_14971&action=edit&section=1" title="Edit section: Background"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>The ISO Technical Committee responsible for the maintenance of this standard is ISO/ TC 210 working with IEC/SC62A through Joint Working Group one (JWG1). This standard is the culmination of the work starting in <a href="/w/index.php?title=ISO/IEC_Guide_51&action=edit&redlink=1" class="new" title="ISO/IEC Guide 51 (page does not exist)">ISO/IEC Guide 51</a>,<sup id="cite_ref-3" class="reference"><a href="#cite_note-3"><span class="cite-bracket">[</span>3<span class="cite-bracket">]</span></a></sup> and <a href="/w/index.php?title=ISO/IEC_Guide_63&action=edit&redlink=1" class="new" title="ISO/IEC Guide 63 (page does not exist)">ISO/IEC Guide 63</a>.<sup id="cite_ref-4" class="reference"><a href="#cite_note-4"><span class="cite-bracket">[</span>4<span class="cite-bracket">]</span></a></sup> The third edition of ISO 14971 was published in December 2019 and supersedes the second edition of ISO 14971.<sup id="cite_ref-5" class="reference"><a href="#cite_note-5"><span class="cite-bracket">[</span>5<span class="cite-bracket">]</span></a></sup> </p><p>Specifically, ISO 14971 is a nine-part standard which first establishes a framework for risk analysis, evaluation, control, and review, and also specifies a procedure for review and monitoring during production and post-production.<sup id="cite_ref-6" class="reference"><a href="#cite_note-6"><span class="cite-bracket">[</span>6<span class="cite-bracket">]</span></a></sup><sup id="cite_ref-7" class="reference"><a href="#cite_note-7"><span class="cite-bracket">[</span>7<span class="cite-bracket">]</span></a></sup> </p><p>ISO 14971:2012 was harmonized with respect to the three European Directives associated with medical devices through the three 'Zed' Annexes (ZA, ZB & ZC). The Annex ZA harmonized ISO 14971:2012 with the <a href="/wiki/Medical_Devices_Directive" title="Medical Devices Directive">Medical Devices Directive</a> 93/42/EEC of 1993.<sup id="cite_ref-8" class="reference"><a href="#cite_note-8"><span class="cite-bracket">[</span>8<span class="cite-bracket">]</span></a></sup> The Annex ZB harmonized ISO 14971:2012 with the Active Implantable Medical Device Directive 90/385/EEC of 1990.<sup id="cite_ref-9" class="reference"><a href="#cite_note-9"><span class="cite-bracket">[</span>9<span class="cite-bracket">]</span></a></sup> The Annex ZC harmonized ISO 14971:2012 with the In-vitro Diagnostic Medical Device Directive 98/79/EC of 1998.<sup id="cite_ref-10" class="reference"><a href="#cite_note-10"><span class="cite-bracket">[</span>10<span class="cite-bracket">]</span></a></sup> </p><p>The 2021 addendum to ISO 14971 (ISO 14971:2019+A11:2021) was published to harmonize ISO 14971 and two European Regulations associated with medical devices through the two 'Zed' Annexes (ZA & ZB). The Annex ZA harmonized ISO 14971 with the European Union's Medical Device Regulation (2017/745) of 2017.<sup id="cite_ref-11" class="reference"><a href="#cite_note-11"><span class="cite-bracket">[</span>11<span class="cite-bracket">]</span></a></sup> The Annex ZB harmonized ISO 14971 with the European Union's Medical Device Regulation (2017/746) of 2017.<sup id="cite_ref-12" class="reference"><a href="#cite_note-12"><span class="cite-bracket">[</span>12<span class="cite-bracket">]</span></a></sup> </p> <div class="mw-heading mw-heading2"><h2 id="Guidance_Documents">Guidance Documents</h2><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=ISO_14971&action=edit&section=2" title="Edit section: Guidance Documents"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>ISO/TR 24971<sup id="cite_ref-13" class="reference"><a href="#cite_note-13"><span class="cite-bracket">[</span>13<span class="cite-bracket">]</span></a></sup> was published in 2013 by the ISO TC 210 technical committee to provide expert guidance on the application of this standard. The second edition of ISO 24971 was published in 2020 and contains some of the informative annexes from the second edition of ISO 14971.<sup id="cite_ref-14" class="reference"><a href="#cite_note-14"><span class="cite-bracket">[</span>14<span class="cite-bracket">]</span></a></sup> </p> <div class="mw-heading mw-heading2"><h2 id="ISO_14971_risk_management_options">ISO 14971 risk management options</h2><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=ISO_14971&action=edit&section=3" title="Edit section: ISO 14971 risk management options"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <div class="mw-heading mw-heading3"><h3 id="Inherent_safety_by_design">Inherent safety by design</h3><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=ISO_14971&action=edit&section=4" title="Edit section: Inherent safety by design"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>For example: </p> <ul><li>Use specific connectors that cannot be connected to the wrong component.</li> <li>Remove features that can be mistakenly selected or eliminate an interaction when it could lead to use error.</li> <li>Improve the detectability or readability of controls, labels, and displays.</li> <li>Automate device functions that are prone to use error when users perform the task manually.<sup id="cite_ref-FDA_15-0" class="reference"><a href="#cite_note-FDA-15"><span class="cite-bracket">[</span>15<span class="cite-bracket">]</span></a></sup></li></ul> <div class="mw-heading mw-heading3"><h3 id="Protective_measures_in_the_medical_device_itself_or_in_the_manufacturing_process">Protective measures in the medical device itself or in the manufacturing process</h3><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=ISO_14971&action=edit&section=5" title="Edit section: Protective measures in the medical device itself or in the manufacturing process"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>For example: </p> <ul><li>Incorporate safety mechanisms such as physical safety guards, shielded elements, or software or hardware interlocks.</li> <li>Include warning screens to advise the user of essential conditions that should exist prior to proceeding with device use, such as specific data entry.</li> <li>Use alerts for hazardous conditions, such as a “low battery” alert when an unexpected loss of the device’s operation could cause harm or death.</li> <li>Use device technologies that require less maintenance or are “maintenance free.” <sup id="cite_ref-FDA_15-1" class="reference"><a href="#cite_note-FDA-15"><span class="cite-bracket">[</span>15<span class="cite-bracket">]</span></a></sup></li></ul> <div class="mw-heading mw-heading3"><h3 id="Information_for_safety">Information for safety</h3><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=ISO_14971&action=edit&section=6" title="Edit section: Information for safety"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>For example: </p> <ul><li>Provide written information, such as warning or caution statements in the user manual that highlight and clearly discuss the use-related hazard.</li> <li>Train users to avoid the use error.<sup id="cite_ref-FDA_15-2" class="reference"><a href="#cite_note-FDA-15"><span class="cite-bracket">[</span>15<span class="cite-bracket">]</span></a></sup><sup id="cite_ref-16" class="reference"><a href="#cite_note-16"><span class="cite-bracket">[</span>16<span class="cite-bracket">]</span></a></sup></li></ul> <div class="mw-heading mw-heading2"><h2 id="Changes_in_the_ISO_14971:2019_edition">Changes in the ISO 14971:2019 edition</h2><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=ISO_14971&action=edit&section=7" title="Edit section: Changes in the ISO 14971:2019 edition"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>The third edition of the standard from 2019 differs from 14971:2007 not only by a new chapter structure, but also by focus on the benefit-risk ratio. For this, the concept of (medical) benefit is now defined. In addition, there is a stronger focus on the "information from the production and the downstream phases". Some explanations or appendices from the previous edition are outsourced in ISO / TR 24971:2019. </p> <div class="mw-heading mw-heading2"><h2 id="History">History</h2><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=ISO_14971&action=edit&section=8" title="Edit section: History"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <table class="wikitable" width="50%;"> <tbody><tr> <th>Year </th> <th>Description </th></tr> <tr> <td align="center">1997</td> <td>EN 1441 was born in Europe from <a href="/wiki/European_Committee_for_Standardization" title="European Committee for Standardization">European Committee for Standardization</a> (CEN) with the title <i> "Medical devices - Risk analysis." </i> Which will be the basis for developing ISO 14971</td> <td> </td></tr> <tr> <td align="center">1998</td> <td>ISO 14971-1</td> <td> </td></tr> <tr> <td align="center">2000</td> <td>ISO 14971 (1st Edition)</td> <td> </td></tr> <tr> <td align="center">2007</td> <td>ISO 14971 (2nd Edition)</td> <td> </td></tr> <tr> <td align="center">2012</td> <td>EN ISO 14971 the <a href="/wiki/European_Committee_for_Standardization" title="European Committee for Standardization">European Committee for Standardization</a> (CEN) publishes the harmonized European version with respect to the three European directives associated with the medical sector 93/42/EEC, 98/79/EC, 90/385/EEC</td> <td> </td></tr> <tr> <td align="center">2019</td> <td>ISO 14971 (3rd Edition) also published simultaneously in Europe as EN ISO 14971: 2019</td> <td> </td></tr> <tr> <td align="center">2021</td> <td>EN ISO 14971 the <a href="/wiki/European_Committee_for_Standardization" title="European Committee for Standardization">European Committee for Standardization</a> (CEN) publishes the harmonized European version with respect to the two European Regulations associated with the medical sector 2017/745 and 2017/746</td> <td> </td></tr></tbody></table> <div class="mw-heading mw-heading2"><h2 id="See_also">See also</h2><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=ISO_14971&action=edit&section=9" title="Edit section: See also"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <ul><li><a href="/wiki/List_of_ISO_standards" title="List of ISO standards">List of ISO standards</a></li> <li><a href="/wiki/ISO_13485" title="ISO 13485">ISO 13485</a></li> <li><a href="/wiki/Medical_technology" class="mw-redirect" title="Medical technology">Medical technology</a></li> <li><a href="/wiki/Medical_device" title="Medical device">Medical device</a></li> <li><a href="/wiki/Medical_Devices_Directive" title="Medical Devices Directive">Medical Devices Directive</a></li> <li><a href="/wiki/Clinical_Engineering" class="mw-redirect" title="Clinical Engineering">Clinical Engineering</a></li> <li><a href="/wiki/ISO_690" title="ISO 690">ISO 690</a></li></ul> <div class="mw-heading mw-heading2"><h2 id="References">References</h2><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=ISO_14971&action=edit&section=10" title="Edit section: References"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <style data-mw-deduplicate="TemplateStyles:r1239543626">.mw-parser-output .reflist{margin-bottom:0.5em;list-style-type:decimal}@media screen{.mw-parser-output .reflist{font-size:90%}}.mw-parser-output .reflist .references{font-size:100%;margin-bottom:0;list-style-type:inherit}.mw-parser-output .reflist-columns-2{column-width:30em}.mw-parser-output .reflist-columns-3{column-width:25em}.mw-parser-output .reflist-columns{margin-top:0.3em}.mw-parser-output .reflist-columns ol{margin-top:0}.mw-parser-output .reflist-columns li{page-break-inside:avoid;break-inside:avoid-column}.mw-parser-output .reflist-upper-alpha{list-style-type:upper-alpha}.mw-parser-output .reflist-upper-roman{list-style-type:upper-roman}.mw-parser-output .reflist-lower-alpha{list-style-type:lower-alpha}.mw-parser-output .reflist-lower-greek{list-style-type:lower-greek}.mw-parser-output .reflist-lower-roman{list-style-type:lower-roman}</style><div class="reflist"> <div class="mw-references-wrap mw-references-columns"><ol class="references"> <li id="cite_note-1"><span class="mw-cite-backlink"><b><a href="#cite_ref-1">^</a></b></span> <span class="reference-text"><style data-mw-deduplicate="TemplateStyles:r1238218222">.mw-parser-output cite.citation{font-style:inherit;word-wrap:break-word}.mw-parser-output .citation q{quotes:"\"""\"""'""'"}.mw-parser-output .citation:target{background-color:rgba(0,127,255,0.133)}.mw-parser-output .id-lock-free.id-lock-free a{background:url("//upload.wikimedia.org/wikipedia/commons/6/65/Lock-green.svg")right 0.1em center/9px no-repeat}.mw-parser-output .id-lock-limited.id-lock-limited a,.mw-parser-output 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ISO. 2 May 2013<span class="reference-accessdate">. Retrieved <span class="nowrap">13 September</span> 2015</span>.</cite><span title="ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=unknown&rft.btitle=Medical+devices+--+Application+of+risk+management+to+medical+devices&rft.pub=ISO&rft.date=2013-05-02&rft_id=http%3A%2F%2Fwww.iso.org%2Fiso%2Fcatalogue_detail%3Fcsnumber%3D38193&rfr_id=info%3Asid%2Fen.wikipedia.org%3AISO+14971" class="Z3988"></span></span> </li> <li id="cite_note-7"><span class="mw-cite-backlink"><b><a href="#cite_ref-7">^</a></b></span> <span class="reference-text"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1238218222"><cite id="CITEREFManookian" class="citation web cs1">Manookian, Brian. <a rel="nofollow" class="external text" href="https://www.cmtriallawyers.com/blog/2015/02/11/technical-information-about-iso-14971/">"Technical Information About ISO 14971"</a>. 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Retrieved <span class="nowrap">13 September</span> 2015</span>.</cite><span title="ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=unknown&rft.btitle=Technical+Information+About+ISO+14971&rft.pub=Cummings+Manookian&rft.aulast=Manookian&rft.aufirst=Brian&rft_id=https%3A%2F%2Fwww.cmtriallawyers.com%2Fblog%2F2015%2F02%2F11%2Ftechnical-information-about-iso-14971%2F&rfr_id=info%3Asid%2Fen.wikipedia.org%3AISO+14971" class="Z3988"></span></span> </li> <li id="cite_note-8"><span class="mw-cite-backlink"><b><a href="#cite_ref-8">^</a></b></span> <span class="reference-text"><a rel="nofollow" class="external text" href="https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX:31993L0042">Council Directive 93/42/EEC of 14 June 1993</a></span> </li> <li id="cite_note-9"><span class="mw-cite-backlink"><b><a href="#cite_ref-9">^</a></b></span> <span class="reference-text"><a rel="nofollow" class="external text" href="https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX:31990L0385">Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices</a></span> </li> <li id="cite_note-10"><span class="mw-cite-backlink"><b><a href="#cite_ref-10">^</a></b></span> <span class="reference-text"><a rel="nofollow" class="external text" href="http://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX:31998L0079">Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices</a></span> </li> <li id="cite_note-11"><span class="mw-cite-backlink"><b><a href="#cite_ref-11">^</a></b></span> <span class="reference-text"><a rel="nofollow" class="external text" href="http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R0745">REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017</a></span> </li> <li id="cite_note-12"><span class="mw-cite-backlink"><b><a href="#cite_ref-12">^</a></b></span> <span class="reference-text"><a rel="nofollow" class="external text" href="http://eur-lex.europa.eu/eli/reg/2017/746/oj">REGULATION (EU) 2017/746 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017</a></span> </li> <li id="cite_note-13"><span class="mw-cite-backlink"><b><a href="#cite_ref-13">^</a></b></span> <span class="reference-text"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1238218222"><cite class="citation web cs1"><a rel="nofollow" class="external text" href="https://www.iso.org/foreword-supplementary-information.html">"ISO/TR 24971:2013 - Medical devices -- Guidance on the application of ISO 14971"</a>. <i>www.iso.org</i>.</cite><span title="ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=unknown&rft.jtitle=www.iso.org&rft.atitle=ISO%2FTR+24971%3A2013+-+Medical+devices+--+Guidance+on+the+application+of+ISO+14971&rft_id=https%3A%2F%2Fwww.iso.org%2Fforeword-supplementary-information.html&rfr_id=info%3Asid%2Fen.wikipedia.org%3AISO+14971" class="Z3988"></span></span> </li> <li id="cite_note-14"><span class="mw-cite-backlink"><b><a href="#cite_ref-14">^</a></b></span> <span class="reference-text"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1238218222"><cite class="citation web cs1"><a rel="nofollow" class="external text" href="http://www.iso.org/iso/home/store/catalogue_tc/catalogue_detail.htm?csnumber=59587">"ISO/TR 24971:2020 - Medical devices -- Guidance on the application of ISO 14971"</a>. <i>www.iso.org</i>. 18 December 2019.</cite><span title="ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=unknown&rft.jtitle=www.iso.org&rft.atitle=ISO%2FTR+24971%3A2020+-+Medical+devices+--+Guidance+on+the+application+of+ISO+14971&rft.date=2019-12-18&rft_id=http%3A%2F%2Fwww.iso.org%2Fiso%2Fhome%2Fstore%2Fcatalogue_tc%2Fcatalogue_detail.htm%3Fcsnumber%3D59587&rfr_id=info%3Asid%2Fen.wikipedia.org%3AISO+14971" class="Z3988"></span>, the Forward</span> </li> <li id="cite_note-FDA-15"><span class="mw-cite-backlink">^ <a href="#cite_ref-FDA_15-0"><sup><i><b>a</b></i></sup></a> <a href="#cite_ref-FDA_15-1"><sup><i><b>b</b></i></sup></a> <a href="#cite_ref-FDA_15-2"><sup><i><b>c</b></i></sup></a></span> <span class="reference-text"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1238218222"><cite class="citation web cs1"><a rel="nofollow" class="external text" href="https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm259760.pdf">"Applying Human Factors and Usability Engineering to Medical Devices"</a> <span class="cs1-format">(PDF)</span>. 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February 3, 2016.</cite><span title="ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=unknown&rft.btitle=Applying+Human+Factors+and+Usability+Engineering+to+Medical+Devices&rft.pub=U.S.+Department+of+Health+and+Human+Services+Food+and+Drug+Administration&rft.date=2016-02-03&rft_id=https%3A%2F%2Fwww.fda.gov%2Fucm%2Fgroups%2Ffdagov-public%2F%40fdagov-meddev-gen%2Fdocuments%2Fdocument%2Fucm259760.pdf&rfr_id=info%3Asid%2Fen.wikipedia.org%3AISO+14971" class="Z3988"></span> <span class="noviewer" typeof="mw:File"><span><img alt="Public Domain" src="//upload.wikimedia.org/wikipedia/en/thumb/6/62/PD-icon.svg/12px-PD-icon.svg.png" decoding="async" width="12" height="12" class="mw-file-element" srcset="//upload.wikimedia.org/wikipedia/en/thumb/6/62/PD-icon.svg/18px-PD-icon.svg.png 1.5x, //upload.wikimedia.org/wikipedia/en/thumb/6/62/PD-icon.svg/24px-PD-icon.svg.png 2x" data-file-width="196" data-file-height="196" /></span></span> This article incorporates text from this source, which is in the <a href="/wiki/Public_domain" title="Public domain">public domain</a>.</span> </li> <li id="cite_note-16"><span class="mw-cite-backlink"><b><a href="#cite_ref-16">^</a></b></span> <span class="reference-text"><span class="noviewer" typeof="mw:File"><span><img alt="Public Domain" src="//upload.wikimedia.org/wikipedia/en/thumb/6/62/PD-icon.svg/12px-PD-icon.svg.png" decoding="async" width="12" height="12" class="mw-file-element" srcset="//upload.wikimedia.org/wikipedia/en/thumb/6/62/PD-icon.svg/18px-PD-icon.svg.png 1.5x, //upload.wikimedia.org/wikipedia/en/thumb/6/62/PD-icon.svg/24px-PD-icon.svg.png 2x" data-file-width="196" data-file-height="196" /></span></span> One or more of the preceding sentences incorporates text from this source, which is in the <a href="/wiki/Public_domain" title="Public domain">public domain</a>: Applying Human Factors and Usability Engineering to Medical Devices, U.S. Department of Health and Human Services Food and Drug Administration</span> </li> </ol></div></div> <div class="mw-heading mw-heading2"><h2 id="External_links">External links</h2><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=ISO_14971&action=edit&section=11" title="Edit section: External links"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <ul><li><a rel="nofollow" class="external text" href="https://www.iso.org/standard/59752.html">ISO 13485</a>—Medical devices—Quality management systems—Requirements for regulatory purposes</li> <li><a rel="nofollow" class="external text" href="http://www.iso.org/iso/home/standards_development/list_of_iso_technical_committees/iso_technical_committee.htm?commid=54892">ISO TC 210</a>—Quality management and corresponding general aspects for medical devices</li></ul> <div class="navbox-styles"><style data-mw-deduplicate="TemplateStyles:r1129693374">.mw-parser-output .hlist dl,.mw-parser-output .hlist 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class="nobold">by standard number</span></div></th></tr><tr><td class="navbox-abovebelow" colspan="2"><div>List of <a href="/wiki/List_of_ISO_standards" title="List of ISO standards">ISO standards</a> – <a href="/wiki/List_of_ISO_romanizations" title="List of ISO romanizations">ISO romanizations</a> – <a href="/wiki/List_of_IEC_standards" title="List of IEC standards">IEC standards</a></div></td></tr><tr><th scope="row" class="navbox-group" style="width:1%">1–9999</th><td class="navbox-list-with-group navbox-list navbox-odd" style="width:100%;padding:0"><div style="padding:0 0.25em"> <ul><li><a href="/wiki/ISO_1" title="ISO 1">1</a></li> <li><a href="/wiki/ISO_2" title="ISO 2">2</a></li> <li><a href="/wiki/Renard_series" title="Renard series">3</a></li> <li><a href="/wiki/ISO_4" title="ISO 4">4</a></li> <li><a href="/wiki/Film_speed" title="Film speed">6</a></li> <li><a href="/wiki/British_Standard_Pipe" title="British Standard Pipe">7</a></li> <li><a href="/wiki/ISO_9" title="ISO 9">9</a></li> <li><a href="/wiki/A440_(pitch_standard)" title="A440 (pitch standard)">16</a></li> <li><a href="/wiki/Renard_series" title="Renard series">17</a></li> <li><a href="/wiki/ISO_31" title="ISO 31">31</a> <ul><li><a href="/wiki/ISO_31-0" title="ISO 31-0">-0</a></li> <li><a href="/wiki/ISO_31-1" title="ISO 31-1">-1</a></li> <li><a href="/wiki/ISO_31-3" title="ISO 31-3">-3</a></li> <li><a href="/wiki/ISO_31-4" title="ISO 31-4">-4</a></li> <li><a href="/wiki/ISO_31-5" title="ISO 31-5">-5</a></li> <li><a href="/wiki/ISO_31-6" title="ISO 31-6">-6</a></li> <li><a href="/wiki/ISO_31-7" title="ISO 31-7">-7</a></li> <li><a href="/wiki/ISO_31-8" title="ISO 31-8">-8</a></li> <li><a href="/wiki/ISO_31-9" class="mw-redirect" title="ISO 31-9">-9</a></li> <li><a href="/wiki/ISO_31-10" title="ISO 31-10">-10</a></li> <li><a href="/wiki/ISO_31-11" title="ISO 31-11">-11</a></li> <li><a href="/wiki/ISO_31-12" class="mw-redirect" title="ISO 31-12">-12</a></li> <li><a href="/wiki/ISO_31-13" class="mw-redirect" title="ISO 31-13">-13</a></li></ul></li> <li><a href="/wiki/ISO_metric_screw_thread" title="ISO metric screw thread">68-1</a></li> <li><a href="/wiki/ISO_128" title="ISO 128">128</a></li> <li><a href="/wiki/ISO_216" title="ISO 216">216</a></li> <li><a href="/wiki/ISO_217" title="ISO 217">217</a></li> <li><a href="/wiki/Equal-loudness_contour" title="Equal-loudness contour">226</a></li> <li><a href="/wiki/British_Standard_Pipe" title="British Standard Pipe">228</a></li> <li><a href="/wiki/ISO_233" title="ISO 233">233</a></li> <li><a href="/wiki/ISO_259" title="ISO 259">259</a></li> <li><a href="/wiki/ISO_metric_screw_thread" title="ISO metric screw thread">261</a></li> <li><a href="/wiki/ISO_metric_screw_thread" title="ISO metric screw thread">262</a></li> <li><a href="/wiki/Kappa_number" title="Kappa number">302</a></li> <li><a href="/wiki/Vicat_softening_point" title="Vicat softening point">306</a></li> <li><a href="/wiki/Hazard_symbol#Ionizing_radiation_symbol" title="Hazard symbol">361</a></li> <li><a href="/wiki/Power_take-off" title="Power take-off">500</a></li> <li><a href="/wiki/Hot_shoe" title="Hot shoe">518</a></li> <li><a href="/wiki/Prontor-Compur" title="Prontor-Compur">519</a></li> <li><a href="/wiki/ISO_639" title="ISO 639">639</a> <ul><li><a href="/wiki/ISO_639-1" title="ISO 639-1">-1</a></li> <li><a href="/wiki/ISO_639-2" title="ISO 639-2">-2</a></li> <li><a href="/wiki/ISO_639-3" title="ISO 639-3">-3</a></li> <li><a href="/wiki/ISO_639-5" title="ISO 639-5">-5</a></li> <li><a href="/wiki/ISO_639-6" title="ISO 639-6">-6</a></li></ul></li> <li><a href="/wiki/ISO/IEC_646" title="ISO/IEC 646">646</a></li> <li><a href="/wiki/ISO_657" title="ISO 657">657</a></li> <li><a href="/wiki/ISO_668" title="ISO 668">668</a></li> <li><a href="/wiki/ISO_690" title="ISO 690">690</a></li> <li><a href="/wiki/ISO_704" title="ISO 704">704</a></li> <li><a href="/wiki/ISO_732" title="ISO 732">732</a></li> <li><a href="/wiki/Antimagnetic_watch" title="Antimagnetic watch">764</a></li> <li><a href="/wiki/Hole_punch" title="Hole punch">838</a></li> <li><a href="/wiki/ISO_843" title="ISO 843">843</a></li> <li><a href="/wiki/ISO_860" title="ISO 860">860</a></li> <li><a href="/wiki/ISO_898" title="ISO 898">898</a></li> <li><a href="/wiki/ISO_965" title="ISO 965">965</a></li> <li><a href="/wiki/ISO_999" title="ISO 999">999</a></li> <li><a href="/wiki/ISO_1000" title="ISO 1000">1000</a></li> <li><a href="/wiki/Magnetic_ink_character_recognition" title="Magnetic ink character recognition">1004</a></li> <li><a href="/wiki/135_film" title="135 film">1007</a></li> <li><a href="/wiki/OCR-A" title="OCR-A">1073-1</a></li> <li><a href="/wiki/OCR-B" title="OCR-B">1073-2</a></li> <li><a href="/wiki/Longitudinal_redundancy_check" title="Longitudinal redundancy check">1155</a></li> <li><a href="/wiki/Shock-resistant_watch#ISO_1413_shock-resistant_standard" title="Shock-resistant watch">1413</a></li> <li><a href="/wiki/ALGOL_60" title="ALGOL 60">1538</a></li> <li><a href="/wiki/ISO_1629" title="ISO 1629">1629</a></li> <li><a href="/wiki/ISO_1745" title="ISO 1745">1745</a></li> <li><a href="/wiki/COBOL" title="COBOL">1989</a></li> <li><a href="/wiki/ISO_2014" title="ISO 2014">2014</a></li> <li><a href="/wiki/ISO_2015" title="ISO 2015">2015</a></li> <li><a href="/wiki/ISO/IEC_2022" title="ISO/IEC 2022">2022</a></li> <li><a href="/wiki/ISO_2033" title="ISO 2033">2033</a></li> <li><a href="/wiki/ISO_2047" title="ISO 2047">2047</a></li> <li><a href="/wiki/ISBN" title="ISBN">2108</a></li> <li><a href="/wiki/ISO_2145" title="ISO 2145">2145</a></li> <li><a href="/wiki/ISO_2146" title="ISO 2146">2146</a></li> <li><a href="/wiki/Film_speed" title="Film speed">2240</a></li> <li><a href="/wiki/Water_Resistant_mark" title="Water Resistant mark">2281</a></li> <li><a href="/wiki/International_Standard_Atmosphere" title="International Standard Atmosphere">2533</a></li> <li><a href="/wiki/ISO_2709" title="ISO 2709">2709</a></li> <li><a href="/wiki/ISO_2711" title="ISO 2711">2711</a></li> <li><a href="/wiki/Film_speed" title="Film speed">2720</a></li> <li><a href="/wiki/ISO_2788" title="ISO 2788">2788</a></li> <li><a href="/wiki/ISO_2848" title="ISO 2848">2848</a></li> <li><a href="/wiki/ISO_2852" title="ISO 2852">2852</a></li> <li><a href="/wiki/ISO_2921" title="ISO 2921">2921</a></li> <li><a href="/wiki/126_film" title="126 film">3029</a></li> <li><a href="/wiki/ISO_3103" title="ISO 3103">3103</a></li> <li><a href="/wiki/ISO_3166" title="ISO 3166">3166</a> <ul><li><a href="/wiki/ISO_3166-1" title="ISO 3166-1">-1</a></li> <li><a href="/wiki/ISO_3166-2" title="ISO 3166-2">-2</a></li> <li><a href="/wiki/ISO_3166-3" title="ISO 3166-3">-3</a></li></ul></li> <li><a href="/wiki/International_Standard_Serial_Number" class="mw-redirect" title="International Standard Serial Number">3297</a></li> <li><a href="/wiki/ISO_3307" title="ISO 3307">3307</a></li> <li><a href="/wiki/O-ring" title="O-ring">3601</a></li> <li><a href="/wiki/Kunrei-shiki_romanization" title="Kunrei-shiki romanization">3602</a></li> <li><a href="/wiki/ISO_3864" title="ISO 3864">3864</a></li> <li><a href="/wiki/International_Standard_Recording_Code" title="International Standard Recording Code">3901</a></li> <li><a href="/wiki/FDI_World_Dental_Federation_notation" title="FDI World Dental Federation notation">3950</a></li> <li><a href="/wiki/ISO_3977" title="ISO 3977">3977</a></li> <li><a href="/wiki/ISO_4031" title="ISO 4031">4031</a></li> <li><a href="/wiki/ISO_4157" title="ISO 4157">4157</a></li> <li><a href="/wiki/ISO_4165" title="ISO 4165">4165</a></li> <li><a href="/wiki/ISO_4217" title="ISO 4217">4217</a></li> <li><a href="/wiki/ISO/IEC_4909" title="ISO/IEC 4909">4909</a></li> <li><a href="/wiki/ISO/IEC_5218" title="ISO/IEC 5218">5218</a></li> <li><a href="/wiki/ISO_5426" title="ISO 5426">5426</a></li> <li><a href="/wiki/ISO_5427" title="ISO 5427">5427</a></li> <li><a href="/wiki/ISO_5428" title="ISO 5428">5428</a></li> <li><a href="/wiki/Accuracy_and_precision" title="Accuracy and precision">5725</a></li> <li><a href="/wiki/ISO_5775" title="ISO 5775">5775</a></li> <li><a href="/wiki/ISO_5776" title="ISO 5776">5776</a></li> <li><a href="/wiki/Film_speed" title="Film speed">5800</a></li> <li><a href="/wiki/Flowchart" title="Flowchart">5807</a></li> <li><a href="/wiki/ISO_5964" title="ISO 5964">5964</a></li> <li><a href="/wiki/International_Securities_Identification_Number" title="International Securities Identification Number">6166</a></li> <li><a href="/wiki/ISO_6344" title="ISO 6344">6344</a></li> <li><a href="/wiki/ISO_6346" title="ISO 6346">6346</a></li> <li><a href="/wiki/Minimal_BASIC" title="Minimal BASIC">6373</a></li> <li><a href="/wiki/ISO_6385" title="ISO 6385">6385</a></li> <li><a href="/wiki/Water_Resistant_mark" title="Water Resistant mark">6425</a></li> <li><a href="/wiki/ANSI_escape_code" title="ANSI escape code">6429</a></li> <li><a href="/wiki/ISO_6438" title="ISO 6438">6438</a></li> <li><a href="/wiki/ISO/IEC_6523" title="ISO/IEC 6523">6523</a></li> <li><a href="/wiki/ISO_6709" title="ISO 6709">6709</a></li> <li><a href="/wiki/ISO_6943" title="ISO 6943">6943</a></li> <li><a href="/wiki/ISO_7001" title="ISO 7001">7001</a></li> <li><a href="/wiki/ISO_7002" title="ISO 7002">7002</a></li> <li><a href="/wiki/ISO_7010" title="ISO 7010">7010</a></li> <li><a href="/wiki/ISO_7027" title="ISO 7027">7027</a></li> <li><a href="/wiki/ISO/IEC_7064" title="ISO/IEC 7064">7064</a></li> <li><a href="/wiki/Pinyin" title="Pinyin">7098</a></li> <li><a href="/wiki/Pascal_(programming_language)" title="Pascal (programming language)">7185</a></li> <li><a href="/wiki/ISO_7200" title="ISO 7200">7200</a></li> <li><a href="/wiki/OSI_model" title="OSI model">7498</a> <ul><li><a href="/wiki/OSI_model" title="OSI model">-1</a></li></ul></li> <li><a href="/wiki/ISO_7637" title="ISO 7637">7637</a></li> <li><a href="/wiki/ISO_7736" title="ISO 7736">7736</a></li> <li><a href="/wiki/ISO/IEC_7810" title="ISO/IEC 7810">7810</a></li> <li><a href="/wiki/ISO/IEC_7811" title="ISO/IEC 7811">7811</a></li> <li><a href="/wiki/ISO/IEC_7812" title="ISO/IEC 7812">7812</a></li> <li><a href="/wiki/ISO/IEC_7813" title="ISO/IEC 7813">7813</a></li> <li><a href="/wiki/ISO/IEC_7816" title="ISO/IEC 7816">7816</a></li> <li><a href="/wiki/Graphical_Kernel_System" title="Graphical Kernel System">7942</a></li> <li><a href="/wiki/ISO_8000" title="ISO 8000">8000</a></li> <li><a href="/wiki/On-board_diagnostics" title="On-board diagnostics">8093</a></li> <li><a href="/wiki/ISO_8178" title="ISO 8178">8178</a></li> <li><a href="/wiki/Fuel_oil" title="Fuel oil">8217</a></li> <li><a href="/wiki/ISO_8373" class="mw-redirect" title="ISO 8373">8373</a></li> <li><a href="/wiki/ISO_8501-1" title="ISO 8501-1">8501-1</a></li> <li><a href="/wiki/FTAM" title="FTAM">8571</a></li> <li><a href="/wiki/ISO_8583" title="ISO 8583">8583</a></li> <li><a href="/wiki/ISO_8601" title="ISO 8601">8601</a></li> <li><a href="/wiki/Open_Document_Architecture" title="Open Document Architecture">8613</a></li> <li><a href="/wiki/Computer_Graphics_Metafile" title="Computer Graphics Metafile">8632</a></li> <li><a href="/wiki/Graphical_Kernel_System" title="Graphical Kernel System">8651</a></li> <li><a href="/wiki/ISO/IEC_8652" title="ISO/IEC 8652">8652</a></li> <li><a href="/wiki/ISO_8691" title="ISO 8691">8691</a></li> <li><a href="/wiki/Graphical_Kernel_System" title="Graphical Kernel System">8805/8806</a></li> <li><a href="/wiki/Language_Of_Temporal_Ordering_Specification" class="mw-redirect" title="Language Of Temporal Ordering Specification">8807</a></li> <li><a href="/wiki/Fuse_(automotive)" class="mw-redirect" title="Fuse (automotive)">8820-5</a></li> <li><a href="/wiki/ISO/IEC_8859" title="ISO/IEC 8859">8859</a> <ul><li><a href="/wiki/ISO/IEC_8859-1" title="ISO/IEC 8859-1">-1</a></li> <li><a href="/wiki/ISO/IEC_8859-2" title="ISO/IEC 8859-2">-2</a></li> <li><a href="/wiki/ISO/IEC_8859-3" title="ISO/IEC 8859-3">-3</a></li> <li><a href="/wiki/ISO/IEC_8859-4" title="ISO/IEC 8859-4">-4</a></li> <li><a href="/wiki/ISO/IEC_8859-5" title="ISO/IEC 8859-5">-5</a></li> <li><a href="/wiki/ISO/IEC_8859-6" title="ISO/IEC 8859-6">-6</a></li> <li><a href="/wiki/ISO/IEC_8859-7" title="ISO/IEC 8859-7">-7</a></li> <li><a href="/wiki/ISO/IEC_8859-8" title="ISO/IEC 8859-8">-8</a></li> <li><a href="/wiki/ISO-8859-8-I" title="ISO-8859-8-I">-8-I</a></li> <li><a href="/wiki/ISO/IEC_8859-9" title="ISO/IEC 8859-9">-9</a></li> <li><a href="/wiki/ISO/IEC_8859-10" title="ISO/IEC 8859-10">-10</a></li> <li><a href="/wiki/ISO/IEC_8859-11" title="ISO/IEC 8859-11">-11</a></li> <li><a href="/wiki/ISO/IEC_8859-12" class="mw-redirect" title="ISO/IEC 8859-12">-12</a></li> <li><a href="/wiki/ISO/IEC_8859-13" title="ISO/IEC 8859-13">-13</a></li> <li><a href="/wiki/ISO/IEC_8859-14" title="ISO/IEC 8859-14">-14</a></li> <li><a href="/wiki/ISO/IEC_8859-15" title="ISO/IEC 8859-15">-15</a></li> <li><a href="/wiki/ISO/IEC_8859-16" title="ISO/IEC 8859-16">-16</a></li></ul></li> <li><a href="/wiki/Standard_Generalized_Markup_Language" title="Standard Generalized Markup Language">8879</a></li> <li><a href="/wiki/ISO_9000" class="mw-redirect" title="ISO 9000">9000/9001</a></li> <li><a href="/wiki/ASMO_449" title="ASMO 449">9036</a></li> <li><a href="/wiki/SQL" title="SQL">9075</a></li> <li><a href="/wiki/ISO/IEC_9126" title="ISO/IEC 9126">9126</a></li> <li><a href="/wiki/On-board_diagnostics" title="On-board diagnostics">9141</a></li> <li><a href="/wiki/Salt_spray_test" title="Salt spray test">9227</a></li> <li><a href="/wiki/ISO_9241" title="ISO 9241">9241</a></li> <li><a href="/wiki/File_Allocation_Table" title="File Allocation Table">9293</a></li> <li><a href="/wiki/Fiber_Distributed_Data_Interface" title="Fiber Distributed Data Interface">9314</a></li> <li><a href="/wiki/ISO_9362" title="ISO 9362">9362</a></li> <li><a href="/wiki/Shoe_size" title="Shoe size">9407</a></li> <li><a href="/wiki/CHILL" title="CHILL">9496</a></li> <li><a href="/wiki/Manufacturing_Message_Specification" title="Manufacturing Message Specification">9506</a></li> <li><a href="/wiki/ISO/IEC_9529" title="ISO/IEC 9529">9529</a></li> <li><a href="/wiki/ISO_9564" title="ISO 9564">9564</a></li> <li><a href="/wiki/PHIGS" title="PHIGS">9592/9593</a></li> <li><a href="/wiki/X.500" title="X.500">9594</a></li> <li><a href="/wiki/ISO_9660" title="ISO 9660">9660</a></li> <li><a href="/wiki/ISO/IEC_9797-1" title="ISO/IEC 9797-1">9797-1</a></li> <li><a href="/wiki/ISO_9897" title="ISO 9897">9897</a></li> <li><a href="/wiki/ANSI_C" title="ANSI C">9899</a></li> <li><a href="/wiki/POSIX" title="POSIX">9945</a></li> <li><a href="/wiki/Romanization_of_Georgian" title="Romanization of Georgian">9984</a></li> <li><a href="/wiki/Romanization_of_Armenian" title="Romanization of Armenian">9985</a></li> <li><a href="/wiki/ISO/IEC_9995" title="ISO/IEC 9995">9995</a></li></ul> </div></td></tr><tr><th scope="row" class="navbox-group" style="width:1%">10000–19999</th><td class="navbox-list-with-group navbox-list navbox-even" style="width:100%;padding:0"><div style="padding:0 0.25em"> <ul><li><a href="/wiki/ISO_10006" title="ISO 10006">10006</a></li> <li><a href="/wiki/ISO_10007" title="ISO 10007">10007</a></li> <li><a href="/wiki/ISO/IEC_10116" title="ISO/IEC 10116">10116</a></li> <li><a href="/wiki/Whirlpool_(hash_function)" title="Whirlpool (hash function)">10118-3</a></li> <li><a href="/wiki/ISO_10160" title="ISO 10160">10160</a></li> <li><a href="/wiki/ISO_10161" title="ISO 10161">10161</a></li> <li><a href="/wiki/Guidelines_for_the_Definition_of_Managed_Objects" title="Guidelines for the Definition of Managed Objects">10165</a></li> <li><a href="/wiki/Document_Style_Semantics_and_Specification_Language" title="Document Style Semantics and Specification Language">10179</a></li> <li><a href="/wiki/Pascal_(programming_language)#ISO/IEC_10206:1990_Extended_Pascal" title="Pascal (programming language)">10206</a></li> <li><a href="/wiki/ISO_10218" title="ISO 10218">10218</a></li> <li><a href="/wiki/Full_BASIC" title="Full BASIC">10279</a></li> <li><a href="/wiki/ISO_10303" title="ISO 10303">10303</a> <ul><li><a href="/wiki/EXPRESS_(data_modeling_language)" title="EXPRESS (data modeling language)">-11</a></li> <li><a href="/wiki/ISO_10303-21" title="ISO 10303-21">-21</a></li> <li><a href="/wiki/ISO_10303-22" title="ISO 10303-22">-22</a></li> <li><a href="/wiki/ISO_10303-28" title="ISO 10303-28">-28</a></li> <li><a href="/wiki/STEP-NC" title="STEP-NC">-238</a></li></ul></li> <li><a href="/wiki/Market_Identifier_Code" title="Market Identifier Code">10383</a></li> <li><a href="/wiki/ArmSCII" title="ArmSCII">10585</a></li> <li><a href="/wiki/IS-IS" title="IS-IS">10589</a></li> <li><a href="/wiki/ISO_10628" title="ISO 10628">10628</a></li> <li><a href="/wiki/Universal_Coded_Character_Set" title="Universal Coded Character Set">10646</a></li> <li><a href="/wiki/Torx" title="Torx">10664</a></li> <li><a href="/wiki/RM-ODP" title="RM-ODP">10746</a></li> <li><a href="/wiki/Multibus" title="Multibus">10861</a></li> <li><a href="/wiki/International_Standard_Music_Number" title="International Standard Music Number">10957</a></li> <li><a href="/wiki/ISO_10962" title="ISO 10962">10962</a></li> <li><a href="/wiki/ISO/IEC_10967" title="ISO/IEC 10967">10967</a></li> <li><a href="/wiki/ISO/IEEE_11073" title="ISO/IEEE 11073">11073</a></li> <li><a href="/wiki/ISO_11170" title="ISO 11170">11170</a></li> <li><a href="/wiki/MPEG-1" title="MPEG-1">11172</a></li> <li><a href="/wiki/ISO/IEC_11179" title="ISO/IEC 11179">11179</a></li> <li><a href="/wiki/ISO/IEC_11404" title="ISO/IEC 11404">11404</a></li> <li><a href="/wiki/JBIG" title="JBIG">11544</a></li> <li><a href="/wiki/ISO_11783" title="ISO 11783">11783</a></li> <li><a href="/wiki/ISO_11784_and_ISO_11785" title="ISO 11784 and ISO 11785">11784</a></li> <li><a href="/wiki/ISO_11784_and_ISO_11785" title="ISO 11784 and ISO 11785">11785</a></li> <li><a href="/wiki/ISO/IEC_11801" title="ISO/IEC 11801">11801</a></li> <li><a href="/wiki/Trusted_Platform_Module" title="Trusted Platform Module">11889</a></li> <li><a href="/wiki/CAN_bus#CAN_lower-layer_standards" title="CAN bus">11898</a></li> <li><a href="/wiki/ISO_11940" title="ISO 11940">11940</a> (<a href="/wiki/ISO_11940-2" title="ISO 11940-2">-2</a>)</li> <li><a href="/wiki/ISO/TR_11941" title="ISO/TR 11941">11941</a></li> <li><a href="/wiki/ISO/TR_11941" title="ISO/TR 11941">11941 (TR)</a></li> <li><a href="/wiki/ISO_11992" title="ISO 11992">11992</a></li> <li><a href="/wiki/ISO_12006" title="ISO 12006">12006</a></li> <li><a href="/wiki/DICOM" title="DICOM">12052</a></li> <li><a href="/wiki/ISO/IEC_TR_12182" title="ISO/IEC TR 12182">12182</a></li> <li><a href="/wiki/ISO/IEC_12207" title="ISO/IEC 12207">12207</a></li> <li><a href="/wiki/TIFF/EP" title="TIFF/EP">12234-2</a></li> <li><a href="/wiki/Linguistic_categories#ISO_12620_(ISO_TC37_Data_Category_Registry,_ISOcat)" title="Linguistic categories">12620</a></li> <li><a href="/wiki/Prolog" title="Prolog">13211</a> <ul><li><a href="/wiki/Prolog" title="Prolog">-1</a></li> <li><a href="/wiki/Prolog" title="Prolog">-2</a></li></ul></li> <li><a href="/wiki/Isofix" title="Isofix">13216</a></li> <li><a href="/wiki/Topic_map" title="Topic map">13250</a></li> <li><a href="/wiki/ISO_13399" title="ISO 13399">13399</a></li> <li><a href="/wiki/ISO_13406-2" title="ISO 13406-2">13406-2</a></li> <li><a href="/wiki/110_film" title="110 film">13450</a></li> <li><a href="/wiki/ISO_13485" title="ISO 13485">13485</a></li> <li><a href="/wiki/ISO_13490" title="ISO 13490">13490</a></li> <li><a href="/wiki/ISO_13567" title="ISO 13567">13567</a></li> <li><a href="/wiki/Z_notation" title="Z notation">13568</a></li> <li><a href="/wiki/ISO_13584" title="ISO 13584">13584</a></li> <li><a href="/wiki/International_Bank_Account_Number" title="International Bank Account Number">13616</a></li> <li><a href="/wiki/ISLISP" title="ISLISP">13816</a></li> <li><a href="/wiki/MPEG-2" title="MPEG-2">13818</a></li> <li><a href="/wiki/ISO_14000" class="mw-redirect" title="ISO 14000">14000</a></li> <li><a href="/wiki/ISO_14031" title="ISO 14031">14031</a></li> <li><a href="/wiki/ISO_14224" title="ISO 14224">14224</a></li> <li><a href="/wiki/PDF/UA" title="PDF/UA">14289</a></li> <li><a href="/wiki/Horsepower" title="Horsepower">14396</a></li> <li><a href="/wiki/ISO/IEC_14443" title="ISO/IEC 14443">14443</a></li> <li><a href="/wiki/MPEG-4" title="MPEG-4">14496</a> <ul><li><a href="/wiki/MPEG-4_Part_2" title="MPEG-4 Part 2">-2</a></li> <li><a href="/wiki/MPEG-4_Part_3" title="MPEG-4 Part 3">-3</a></li> <li><a href="/wiki/Delivery_Multimedia_Integration_Framework" title="Delivery Multimedia Integration Framework">-6</a></li> <li><a href="/wiki/Advanced_Video_Coding" title="Advanced Video Coding">-10</a></li> <li><a href="/wiki/MPEG-4_Part_11" title="MPEG-4 Part 11">-11</a></li> <li><a href="/wiki/ISO_base_media_file_format" title="ISO base media file format">-12</a></li> <li><a href="/wiki/MP4_file_format" title="MP4 file format">-14</a></li> <li><a href="/wiki/MP4_file_format" title="MP4 file format">-17</a></li> <li><a href="/wiki/MP4_file_format" title="MP4 file format">-20</a></li></ul></li> <li><a href="/wiki/ISO_14617" title="ISO 14617">14617</a></li> <li><a href="/wiki/ISO_14644" title="ISO 14644">14644</a></li> <li><a href="/wiki/STEP-NC" title="STEP-NC">14649</a></li> <li><a href="/wiki/ISO/IEC_14651" title="ISO/IEC 14651">14651</a></li> <li><a href="/wiki/ISO_14698" title="ISO 14698">14698</a></li> <li><a href="/wiki/Software_maintenance" title="Software maintenance">14764</a></li> <li><a href="/wiki/C%2B%2B" title="C++">14882</a></li> <li><a class="mw-selflink selflink">14971</a></li> <li><a href="/wiki/ISO_15022" title="ISO 15022">15022</a></li> <li><a href="/wiki/ISO_15189" title="ISO 15189">15189</a></li> <li><a href="/wiki/ISO/IEC_15288" title="ISO/IEC 15288">15288</a></li> <li><a href="/wiki/Ada_Semantic_Interface_Specification" title="Ada Semantic Interface Specification">15291</a></li> <li><a href="/wiki/ISO_15398" title="ISO 15398">15398</a></li> <li><a href="/wiki/Common_Criteria" title="Common Criteria">15408</a></li> <li><a href="/wiki/JPEG_2000" title="JPEG 2000">15444</a> <ul><li><a href="/wiki/Motion_JPEG_2000" title="Motion JPEG 2000">-3</a></li> <li><a href="/wiki/JPIP" title="JPIP">-9</a></li></ul></li> <li><a href="/wiki/HTML" title="HTML">15445</a></li> <li><a href="/wiki/PDF417" title="PDF417">15438</a></li> <li><a href="/wiki/ISO/IEC_15504" title="ISO/IEC 15504">15504</a></li> <li><a href="/wiki/International_Standard_Identifier_for_Libraries_and_Related_Organizations" title="International Standard Identifier for Libraries and Related Organizations">15511</a></li> <li><a href="/wiki/ISO_15686" title="ISO 15686">15686</a></li> <li><a href="/wiki/ISO/IEC_15693" title="ISO/IEC 15693">15693</a></li> <li><a href="/wiki/International_Standard_Audiovisual_Number" title="International Standard Audiovisual Number">15706</a> <ul><li><a href="/wiki/International_Standard_Audiovisual_Number" title="International Standard Audiovisual Number">-2</a></li></ul></li> <li><a href="/wiki/International_Standard_Musical_Work_Code" title="International Standard Musical Work Code">15707</a></li> <li><a href="/wiki/ISO/IEC_15897" title="ISO/IEC 15897">15897</a></li> <li><a href="/wiki/ISO_15919" title="ISO 15919">15919</a></li> <li><a href="/wiki/ISO_15924" title="ISO 15924">15924</a></li> <li><a href="/wiki/ISO_15926" title="ISO 15926">15926</a></li> <li><a href="/wiki/ISO_15926_WIP" title="ISO 15926 WIP">15926 WIP</a></li> <li><a href="/wiki/PDF/X" title="PDF/X">15930</a></li> <li><a href="/wiki/MPEG-7" title="MPEG-7">15938</a></li> <li><a href="/wiki/MaxiCode" title="MaxiCode">16023</a></li> <li><a href="/wiki/ECMAScript" title="ECMAScript">16262</a></li> <li><a href="/wiki/Quality_function_deployment" title="Quality function deployment">16355-1</a></li> <li><a href="/wiki/Mixed_raster_content" title="Mixed raster content">16485</a></li> <li><a href="/wiki/PDF/VT" title="PDF/VT">16612-2</a></li> <li><a href="/wiki/ISO_16750" title="ISO 16750">16750</a></li> <li><a href="/wiki/IATF_16949" title="IATF 16949">16949 (TS)</a></li> <li><a href="/wiki/ISO/IEC_17024" title="ISO/IEC 17024">17024</a></li> <li><a href="/wiki/ISO/IEC_17025" title="ISO/IEC 17025">17025</a></li> <li><a href="/wiki/ISO_17100" title="ISO 17100">17100</a></li> <li><a href="/wiki/Open_Virtualization_Format" title="Open Virtualization Format">17203</a></li> <li><a href="/wiki/SDMX" title="SDMX">17369</a></li> <li><a href="/wiki/Legal_Entity_Identifier" title="Legal Entity Identifier">17442</a></li> <li><a href="/wiki/COLLADA" title="COLLADA">17506</a></li> <li><a href="/wiki/ISO/IEC_27002" title="ISO/IEC 27002">17799</a></li> <li><a href="/wiki/QR_code" title="QR code">18004</a></li> <li><a href="/wiki/ISO/IEC_18014" title="ISO/IEC 18014">18014</a></li> <li><a href="/wiki/JPEG_XL" title="JPEG XL">18181</a></li> <li><a href="/wiki/ISO_18245" title="ISO 18245">18245</a></li> <li><a href="/wiki/Process_Specification_Language" title="Process Specification Language">18629</a></li> <li><a href="/wiki/Photographic_Activity_Test" title="Photographic Activity Test">18916</a></li> <li><a href="/wiki/PDF/A" title="PDF/A">19005</a></li> <li><a href="/wiki/ISO_19011" title="ISO 19011">19011</a></li> <li><a href="/wiki/ISO_19092-1" class="mw-redirect" title="ISO 19092-1">19092</a> <ul><li><a href="/wiki/ISO_19092-1" class="mw-redirect" title="ISO 19092-1">-1</a></li> <li><a href="/wiki/ISO_19092-2" class="mw-redirect" title="ISO 19092-2">-2</a></li></ul></li> <li><a href="/wiki/ISO_19114" title="ISO 19114">19114</a></li> <li><a href="/wiki/Geospatial_metadata#ISO_19115:_Geographic_information_–_Metadata" title="Geospatial metadata">19115</a></li> <li><a href="/wiki/Simple_Features" title="Simple Features">19125</a></li> <li><a href="/wiki/Geography_Markup_Language#ISO_19136" title="Geography Markup Language">19136</a></li> <li><a href="/wiki/Shoe_size" title="Shoe size">19407</a></li> <li><a href="/wiki/ISO_19439" title="ISO 19439">19439</a></li> <li><a href="/wiki/Common_Object_Request_Broker_Architecture" title="Common Object Request Broker Architecture">19500</a></li> <li><a href="/wiki/Unified_Modeling_Language" title="Unified Modeling Language">19501</a></li> <li><a href="/wiki/Meta-Object_Facility" title="Meta-Object Facility">19502</a></li> <li><a href="/wiki/XML_Metadata_Interchange" title="XML Metadata Interchange">19503</a></li> <li><a href="/wiki/Unified_Modeling_Language" title="Unified Modeling Language">19505</a></li> <li><a href="/wiki/Knowledge_Discovery_Metamodel" title="Knowledge Discovery Metamodel">19506</a></li> <li><a href="/wiki/Object_Constraint_Language" title="Object Constraint Language">19507</a></li> <li><a href="/wiki/Meta-Object_Facility" title="Meta-Object Facility">19508</a></li> <li><a href="/wiki/XML_Metadata_Interchange" title="XML Metadata Interchange">19509</a></li> <li><a href="/wiki/Business_Process_Model_and_Notation" title="Business Process Model and Notation">19510</a></li> <li><a href="/wiki/ISO_19600" title="ISO 19600">19600</a></li> <li><a href="/wiki/ISO/IEC_19752" title="ISO/IEC 19752">19752</a></li> <li><a href="/wiki/RELAX_NG" title="RELAX NG">19757</a></li> <li><a href="/wiki/ISO/IEC_19770" title="ISO/IEC 19770">19770</a></li> <li><a href="/wiki/X3D" title="X3D">19775-1</a></li> <li><a href="/wiki/ISO/IEC_19794-5" title="ISO/IEC 19794-5">19794-5</a></li> <li><a href="/wiki/Cloud_Infrastructure_Management_Interface" title="Cloud Infrastructure Management Interface">19831</a></li></ul> </div></td></tr><tr><th scope="row" class="navbox-group" style="width:1%">20000–29999</th><td class="navbox-list-with-group navbox-list navbox-odd" style="width:100%;padding:0"><div style="padding:0 0.25em"> <ul><li><a href="/wiki/ISO/IEC_20000" title="ISO/IEC 20000">20000</a></li> <li><a href="/wiki/ISO_20022" title="ISO 20022">20022</a></li> <li><a href="/wiki/ISO_20121" title="ISO 20121">20121</a></li> <li><a href="/wiki/ISO_20400" title="ISO 20400">20400</a></li> <li><a href="/wiki/Open_Data_Protocol" title="Open Data Protocol">20802</a></li> <li><a href="/wiki/Han_Xin_code" title="Han Xin code">20830</a></li> <li><a href="/wiki/MPEG-21" title="MPEG-21">21000</a></li> <li><a href="/wiki/ISO_21001" title="ISO 21001">21001</a></li> <li><a href="/wiki/International_Standard_Text_Code" title="International Standard Text Code">21047</a></li> <li><a href="/wiki/JPEG_XS" title="JPEG XS">21122</a></li> <li><a href="/wiki/ISO_21500" title="ISO 21500">21500</a></li> <li><a href="/wiki/ISO/IEC_21827" title="ISO/IEC 21827">21827</a></li> <li><a href="/wiki/ISO_22000" title="ISO 22000">22000</a></li> <li><a href="/wiki/ECMAScript" title="ECMAScript">22275</a></li> <li><a href="/wiki/ISO_22300" title="ISO 22300">22300</a></li> <li><a href="/wiki/ISO_22301" title="ISO 22301">22301</a></li> <li><a href="/wiki/ISO_22395" title="ISO 22395">22395</a></li> <li><a href="/wiki/ECMAScript_for_XML" title="ECMAScript for XML">22537</a></li> <li><a href="/wiki/MPEG-A" title="MPEG-A">23000</a></li> <li><a href="/wiki/MPEG-D" title="MPEG-D">23003</a></li> <li><a href="/wiki/MPEG-H" title="MPEG-H">23008</a></li> <li><a href="/wiki/Dynamic_Adaptive_Streaming_over_HTTP" title="Dynamic Adaptive Streaming over HTTP">23009</a></li> <li><a href="/wiki/Versatile_Video_Coding" title="Versatile Video Coding">23090-3</a></li> <li><a href="/wiki/MPEG-G" title="MPEG-G">23092</a></li> <li><a href="/wiki/Essential_Video_Coding" title="Essential Video Coding">23094-1</a></li> <li><a href="/wiki/LCEVC" title="LCEVC">23094-2</a></li> <li><a href="/wiki/C_Sharp_(programming_language)" title="C Sharp (programming language)">23270</a></li> <li><a href="/wiki/Common_Language_Infrastructure" title="Common Language Infrastructure">23271</a></li> <li><a href="/wiki/Linux_Standard_Base" title="Linux Standard Base">23360</a></li> <li><a href="/wiki/Rectangular_Micro_QR_Code" title="Rectangular Micro QR Code">23941</a></li> <li><a href="/wiki/PDF/E" title="PDF/E">24517</a></li> <li><a href="/wiki/Lexical_Markup_Framework" title="Lexical Markup Framework">24613</a></li> <li><a href="/wiki/ISO-TimeML" title="ISO-TimeML">24617</a></li> <li><a href="/wiki/Common_Logic" title="Common Logic">24707</a></li> <li><a href="/wiki/MicroPDF417" title="MicroPDF417">24728</a></li> <li><a href="/wiki/ISO_25178" title="ISO 25178">25178</a></li> <li><a href="/wiki/ISO_25964" title="ISO 25964">25964</a></li> <li><a href="/wiki/ISO_26000" title="ISO 26000">26000</a></li> <li><a href="/wiki/ISO_26262" title="ISO 26262">26262</a></li> <li><a href="/wiki/OpenDocument" title="OpenDocument">26300</a></li> <li><a href="/wiki/Digital_object_identifier" title="Digital object identifier">26324</a></li> <li><a href="/wiki/ISO/IEC_27000-series" class="mw-redirect" title="ISO/IEC 27000-series">27000 series</a></li> <li><a href="/wiki/ISO/IEC_27000" title="ISO/IEC 27000">27000</a></li> <li><a href="/wiki/ISO/IEC_27001" title="ISO/IEC 27001">27001</a></li> <li><a href="/wiki/ISO/IEC_27002" title="ISO/IEC 27002">27002</a></li> <li><a href="/wiki/ISO/IEC_27005" title="ISO/IEC 27005">27005</a></li> <li><a href="/wiki/ISO/IEC_27006" title="ISO/IEC 27006">27006</a></li> <li><a href="/wiki/International_Standard_Name_Identifier" title="International Standard Name Identifier">27729</a></li> <li><a href="/wiki/ISO_28000" title="ISO 28000">28000</a></li> <li>29110</li> <li><a href="/wiki/Requirements_engineering" title="Requirements engineering">29148</a></li> <li><a href="/wiki/JPEG_XR" title="JPEG XR">29199-2</a></li> <li><a href="/wiki/Office_Open_XML" title="Office Open XML">29500</a></li></ul> </div></td></tr><tr><th scope="row" class="navbox-group" style="width:1%">30000+</th><td class="navbox-list-with-group navbox-list navbox-even" style="width:100%;padding:0"><div style="padding:0 0.25em"> <ul><li><a href="/wiki/Ruby_(programming_language)" title="Ruby (programming language)">30170</a></li> <li><a href="/wiki/ISO_31000" title="ISO 31000">31000</a></li> <li><a href="/wiki/PDF" title="PDF">32000</a></li> <li><a href="/wiki/ISO_37001" title="ISO 37001">37001</a></li> <li><a href="/wiki/ISO/IEC_38500" title="ISO/IEC 38500">38500</a></li> <li><a href="/wiki/Graph_Query_Language" title="Graph Query Language">39075</a></li> <li><a href="/wiki/Web_Content_Accessibility_Guidelines" title="Web Content Accessibility Guidelines">40500</a></li> <li><a href="/wiki/ISO/IEC_42010" title="ISO/IEC 42010">42010</a></li> <li><a href="/wiki/ISO_45001" title="ISO 45001">45001</a></li> <li><a href="/wiki/ISO_50001" title="ISO 50001">50001</a></li> <li><a href="/wiki/ISO_55000" title="ISO 55000">55000</a></li> <li><a href="/wiki/ISO_56000" title="ISO 56000">56000</a></li> <li><a href="/wiki/ISO/IEC_80000" title="ISO/IEC 80000">80000</a></li></ul> </div></td></tr><tr><td class="navbox-abovebelow" colspan="2"><div> <ul><li><span class="noviewer" typeof="mw:File"><span title="Category"><img alt="" src="//upload.wikimedia.org/wikipedia/en/thumb/9/96/Symbol_category_class.svg/16px-Symbol_category_class.svg.png" decoding="async" width="16" height="16" class="mw-file-element" srcset="//upload.wikimedia.org/wikipedia/en/thumb/9/96/Symbol_category_class.svg/23px-Symbol_category_class.svg.png 1.5x, //upload.wikimedia.org/wikipedia/en/thumb/9/96/Symbol_category_class.svg/31px-Symbol_category_class.svg.png 2x" data-file-width="180" data-file-height="185" /></span></span> <a href="/wiki/Category:ISO_standards" title="Category:ISO standards">Category</a></li></ul> </div></td></tr></tbody></table></div>    </div><noscript><img src="https://login.wikimedia.org/wiki/Special:CentralAutoLogin/start?type=1x1" alt="" 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