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class="vector-toc-numb">2</span> <span>Reason for use</span> </div> </a> <ul id="toc-Reason_for_use-sublist" class="vector-toc-list"> </ul> </li> <li id="toc-Chronology" class="vector-toc-list-item vector-toc-level-1 vector-toc-list-item-expanded"> <a class="vector-toc-link" href="#Chronology"> <div class="vector-toc-text"> <span class="vector-toc-numb">3</span> <span>Chronology</span> </div> </a> <ul id="toc-Chronology-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">4</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">5</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">6</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 class="mw-body-header vector-page-titlebar"> <nav aria-label="Contents" class="vector-toc-landmark"> <div id="vector-page-titlebar-toc" class="vector-dropdown vector-page-titlebar-toc vector-button-flush-left" > <input type="checkbox" id="vector-page-titlebar-toc-checkbox" role="button" aria-haspopup="true" data-event-name="ui.dropdown-vector-page-titlebar-toc" class="vector-dropdown-checkbox " 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Available in 14 languages" > <label id="p-lang-btn-label" for="p-lang-btn-checkbox" class="vector-dropdown-label cdx-button cdx-button--fake-button cdx-button--fake-button--enabled cdx-button--weight-quiet cdx-button--action-progressive mw-portlet-lang-heading-14" aria-hidden="true" ><span class="vector-icon mw-ui-icon-language-progressive mw-ui-icon-wikimedia-language-progressive"></span> <span class="vector-dropdown-label-text">14 languages</span> </label> <div class="vector-dropdown-content"> <div class="vector-menu-content"> <ul class="vector-menu-content-list"> <li class="interlanguage-link interwiki-da mw-list-item"><a href="https://da.wikipedia.org/wiki/ISO_13485" title="ISO 13485 – Danish" lang="da" hreflang="da" data-title="ISO 13485" data-language-autonym="Dansk" data-language-local-name="Danish" class="interlanguage-link-target"><span>Dansk</span></a></li><li class="interlanguage-link interwiki-de mw-list-item"><a href="https://de.wikipedia.org/wiki/ISO_13485" title="ISO 13485 – German" lang="de" hreflang="de" data-title="ISO 13485" data-language-autonym="Deutsch" data-language-local-name="German" class="interlanguage-link-target"><span>Deutsch</span></a></li><li class="interlanguage-link interwiki-es mw-list-item"><a href="https://es.wikipedia.org/wiki/ISO_13485" title="ISO 13485 – Spanish" lang="es" hreflang="es" data-title="ISO 13485" data-language-autonym="Español" data-language-local-name="Spanish" class="interlanguage-link-target"><span>Español</span></a></li><li class="interlanguage-link interwiki-fa mw-list-item"><a href="https://fa.wikipedia.org/wiki/%D8%A7%DB%8C%D8%B2%D9%88_%DB%B1%DB%B3%DB%B4%DB%B8%DB%B5" title="ایزو ۱۳۴۸۵ – Persian" lang="fa" hreflang="fa" data-title="ایزو ۱۳۴۸۵" data-language-autonym="فارسی" data-language-local-name="Persian" class="interlanguage-link-target"><span>فارسی</span></a></li><li class="interlanguage-link interwiki-fr mw-list-item"><a href="https://fr.wikipedia.org/wiki/ISO_13485" title="ISO 13485 – French" lang="fr" hreflang="fr" data-title="ISO 13485" data-language-autonym="Français" data-language-local-name="French" class="interlanguage-link-target"><span>Français</span></a></li><li class="interlanguage-link interwiki-hr mw-list-item"><a href="https://hr.wikipedia.org/wiki/ISO_13485" title="ISO 13485 – Croatian" lang="hr" hreflang="hr" data-title="ISO 13485" data-language-autonym="Hrvatski" data-language-local-name="Croatian" class="interlanguage-link-target"><span>Hrvatski</span></a></li><li class="interlanguage-link interwiki-id mw-list-item"><a href="https://id.wikipedia.org/wiki/ISO_13485" title="ISO 13485 – Indonesian" lang="id" hreflang="id" data-title="ISO 13485" data-language-autonym="Bahasa Indonesia" data-language-local-name="Indonesian" class="interlanguage-link-target"><span>Bahasa Indonesia</span></a></li><li class="interlanguage-link interwiki-it mw-list-item"><a href="https://it.wikipedia.org/wiki/ISO_13485" title="ISO 13485 – Italian" lang="it" hreflang="it" 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dir="ltr"><div class="shortdescription nomobile noexcerpt noprint searchaux" style="display:none">ISO standard</div> <p><b>ISO 13485</b> <i>Medical devices -- Quality management systems -- Requirements for regulatory purposes</i> is a voluntary 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 1996, and contains a comprehensive <a href="/wiki/Quality_management_system" title="Quality management system">quality management system</a> for the design and manufacture of <a href="/wiki/Medical_device" title="Medical device">medical devices</a>. The latest version of this standard supersedes earlier documents such as EN 46001 (1993 and 1996) and EN 46002 (1996), the previously published ISO 13485 (1996 and 2003), and ISO 13488 (also 1996). </p><p>The current ISO 13485 edition was published on 1 March 2016.<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> <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_13485&action=edit&section=1" title="Edit section: Background"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>Though it is tailored to the industry's quality system expectations and regulatory requirements, an organization does not need to be actively manufacturing medical devices or their components to seek certification to this standard, in contrast to the automotive sector's <a href="/wiki/ISO/TS_16949" class="mw-redirect" title="ISO/TS 16949">ISO/TS 16949</a>, where only firms with an active <a href="/wiki/Request_for_quotation" title="Request for quotation">request for quotation</a>, or on the bid list, of an <a href="/wiki/International_Automotive_Task_Force" title="International Automotive Task Force">International Automotive Task Force</a> supply chain manufacturer can seek registration.<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> </p> <div class="mw-heading mw-heading2"><h2 id="Reason_for_use">Reason for use</h2><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=ISO_13485&action=edit&section=2" title="Edit section: Reason for use"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>While it remains a stand-alone document, ISO 13485 is generally harmonized with <a href="/wiki/ISO_9001" class="mw-redirect" title="ISO 9001">ISO 9001</a>. A principal difference, however, is that ISO 9001 requires the organization to demonstrate <a href="/wiki/Continual_improvement" class="mw-redirect" title="Continual improvement">continual improvement</a>, whereas ISO 13485 requires only that the certified organization demonstrate the quality system is effectively implemented and maintained. Additionally, the ISO 9001 requirements regarding <a href="/wiki/Customer_satisfaction" title="Customer satisfaction">customer satisfaction</a> are absent from the medical device standard.<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> </p><p>Other specific differences include: </p> <ul><li>the promotion and awareness of regulatory requirements as a management responsibility. Examples of market-specific regulatory requirements include 21 CFR 820, the Quality System Regulation for medical devices sold in the United States, enforced by the U.S. <a href="/wiki/Food_and_Drug_Administration" title="Food and Drug Administration">Food and Drug Administration</a> (FDA), or the <a href="/wiki/Medical_Devices_Directive" title="Medical Devices Directive">Medical Devices Directive</a> 93/42/EEC, required for doing business in the European Union</li> <li>controls in the work environment to ensure product safety</li> <li>focus on <a href="/wiki/Risk_management" title="Risk management">risk management</a> activities and <a href="/wiki/Design_controls" title="Design controls">design control</a> activities during product development</li> <li>specific requirements for inspection and traceability for implantable devices</li> <li>specific requirements for documentation and validation of processes for sterile medical devices</li> <li>specific requirements for verification of the effectiveness of <a href="/wiki/Corrective_and_preventive_action" title="Corrective and preventive action">corrective and preventive actions</a></li> <li>specific requirements for cleanliness of products</li></ul> <p>Compliance with ISO 13485 is often viewed as the initial step in ensuring adherence to European regulatory requirements. This is particularly significant when it comes to assessing the conformity of Medical Devices and In-vitro Diagnostic Medical Devices in accordance with European Union Directives 93/42/EEC, 90/385/EEC, and 98/79/EEC before allowing their sale. A fundamental aspect of proving conformity lies in the establishment and implementation of a Quality Management System compliant with ISO 9001, ISO 13485, and ISO 14971. While it's important to note that the European Union Directives don't explicitly mandate certification to ISO 9001 and/or ISO 13485, it is the preferred approach for demonstrating compliance to these standards, and this certification is issued by specialized organizations referred to as "Registrars." </p><p>Furthermore, some of these registrars also serve as Notified Bodies, which play a pivotal role in the pre-market assessment of certain medical devices. When a Notified Body conducts a thorough evaluation and issues a positive assessment, it results in the coveted certificate of conformity, granting the CE mark and the authorization to market the medical device within the European Union. It's important to underline that the Notified Body's assessment scrutinizes the company's Quality Management System in great detail, along with a meticulous review of the requisite Technical Documentation. This comprehensive evaluation is a crucial element that the Notified Body takes into account when granting the certificate of conformity for the company's product or products. </p><p>In summary, the journey to compliance with European regulatory requirements for medical devices entails a multi-faceted approach, with ISO 13485 serving as a cornerstone and the involvement of Notified Bodies as a key step to gain the necessary certifications and permissions for market access in the European Union. </p><p>This standard adopted by CEN as EN ISO 13485:2003/AC:2007 is harmonized with respect to the European medical device directives <a href="/wiki/Medical_Devices_Directive" title="Medical Devices Directive">93/42/EEC</a>, 90/385/EEC and 98/79/EC.<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>ISO 13485 is now considered to be inline standard and requirement for medical devices even with "<a href="/wiki/Global_Harmonization_Task_Force" title="Global Harmonization Task Force">Global Harmonization Task Force</a> Guidelines" (GHTF).<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> The GHTF guidelines are slowly becoming universal standards for design, manufacture, export and sales of various medical devices. The GHTF has been replaced in the last few years by the <a href="/w/index.php?title=International_Medical_Device_Regulators_Forum&action=edit&redlink=1" class="new" title="International Medical Device Regulators Forum (page does not exist)">International Medical Device Regulators Forum</a> (IMDRF)<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> and is structured differently from the GHTF as only the regulators, that are primary members of the group, get to make many of the decisions. The IMDRF main membership (the regulators) do want to have non-regulators involved without voting rights and in this way they are hoping to get the process and documents completed quicker than under the GHTF system (regulators & non-regulators were equal in voting rights) that worked reasonably well, but somewhat slow. </p><p>This standard adopted by CEN as EN ISO 13485:2012 is harmonized with respect to the European Medical Devices Directive 93/42/EEC.<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> </p><p>Mexico published on October 11, 2012, a national standard as a <a href="/wiki/Norma_Oficial_Mexicana" title="Norma Oficial Mexicana">Norma Oficial Mexicana</a> (NOM) to control manufacture of medical devices inside the country. NOM-241-SSA1-2012, Buenas Practicas de Fabricación para Establecimientos dedicados a la Fabricación de Dispositivos Médicos.<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 scope of application is mandatory in the national territory, for all establishments dedicated to the process of medical devices marketed in the country. The <a href="/wiki/Federal_Commission_for_the_Protection_against_Sanitary_Risk" title="Federal Commission for the Protection against Sanitary Risk">Cofepris</a> is the body assigned to its control, verification and to grant the records of compliance to the companies that implement this Standard of Good Manufacturing Practices. This standard is partially in line with ISO 13485: 2003 and ISO 9001: 2008. </p><p>In 2017, The Farmacopea de los Estados Unidos Mexicanos (United Mexican States Pharmacopoeia), medical industrial sectors and Cofepris are working together for updating NOM-241 Standard, putting special attention on managing risks during manufacture and regulating by manufacturing lines some of the most important medical devices manufacturing processes. This standard will be published in August 2018, and 180 days after publication it will become mandatory for the industry. </p><p>In Spain, medical devices are named in ISO-13485 as "Sanitary Products" as Castellano-language translation of ISO-13485, but in Mexico they are known as "Medical Devices" and correspond to those used in medical practice and that meet the definition established by NOM-241 as: Medical device, to the substance, mixture of substances, material, apparatus or instrument (including the computer program necessary for its proper use or application), used alone or in combination in the diagnosis, monitoring or prevention of human or auxiliary diseases in the treatment of the same and of the disability, as well as the employees in the replacement, correction, restoration or modification of the anatomy or human physiological processes. Medical devices include products of the following categories: medical equipment, prostheses, orthotics, functional aids, diagnostic agents, supplies for dental use, surgical, healing and hygiene products. ISO 13485:2016 Certificates meets the requirement of IEC 60601-2-25 : 1993 + A1: 1999 safety of Electrocardiograms. </p> <div class="mw-heading mw-heading2"><h2 id="Chronology">Chronology</h2><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=ISO_13485&action=edit&section=3" title="Edit section: Chronology"><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">1993</td> <td>EN 46001 <i>Quality systems – Medical devices – Particular requirements for the application of EN ISO 9001</i> is published by the <a href="/wiki/European_Committee_for_Standardization" title="European Committee for Standardization">European Committee for Standardization</a> (CEN), forming the basis for developing ISO 13485. </td></tr> <tr> <td align="center">1996</td> <td>ISO 13485 (1st Edition). </td></tr> <tr> <td align="center">2000</td> <td>EN ISO 13485 is published by CEN, creating a European Norm version of the international standard, and the previous European standard (EN 46001) is withdrawn. </td></tr> <tr> <td align="center">2003</td> <td>ISO 13485 (2nd Edition). </td></tr> <tr> <td align="center">2012</td> <td>EN ISO 13485 is revised so that it harmonizes with the three European directives associated with the medical sector: 93/42/EEC (medical devices), 98/79/EC (<i>in vitro</i> diagnostic medical devices), and 90/385/EEC (active implantable medical devices). </td></tr> <tr> <td align="center">2016</td> <td>ISO 13485 (3rd Edition). </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_13485&action=edit&section=4" title="Edit section: See also"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <ul><li><a href="/wiki/ISO_14971" title="ISO 14971">ISO 14971</a></li> <li><a href="/wiki/Good_manufacturing_practice" title="Good manufacturing practice">Good manufacturing practice</a></li> <li><a href="/wiki/List_of_International_Organization_for_Standardization_standards" class="mw-redirect" title="List of International Organization for Standardization standards">List of International Organization for Standardization standards</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_13485&action=edit&section=5" 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 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a,body:not(.skin-timeless):not(.skin-minerva) .mw-parser-output .id-lock-limited a,body:not(.skin-timeless):not(.skin-minerva) .mw-parser-output .id-lock-registration a,body:not(.skin-timeless):not(.skin-minerva) .mw-parser-output .id-lock-subscription a,body:not(.skin-timeless):not(.skin-minerva) .mw-parser-output .cs1-ws-icon a{background-size:contain;padding:0 1em 0 0}.mw-parser-output .cs1-code{color:inherit;background:inherit;border:none;padding:inherit}.mw-parser-output .cs1-hidden-error{display:none;color:var(--color-error,#d33)}.mw-parser-output .cs1-visible-error{color:var(--color-error,#d33)}.mw-parser-output .cs1-maint{display:none;color:#085;margin-left:0.3em}.mw-parser-output .cs1-kern-left{padding-left:0.2em}.mw-parser-output .cs1-kern-right{padding-right:0.2em}.mw-parser-output .citation .mw-selflink{font-weight:inherit}@media screen{.mw-parser-output .cs1-format{font-size:95%}html.skin-theme-clientpref-night .mw-parser-output .cs1-maint{color:#18911f}}@media screen and (prefers-color-scheme:dark){html.skin-theme-clientpref-os .mw-parser-output .cs1-maint{color:#18911f}}</style><cite class="citation web cs1"><a rel="nofollow" class="external text" href="https://www.iso.org/foreword-supplementary-information.html">"FOREWORD - SUPPLEMENTARY INFORMATION"</a>. <i>www.iso.org/foreword-supplementary-information.html</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%2Fforeword-supplementary-information.html&rft.atitle=FOREWORD+-+SUPPLEMENTARY+INFORMATION&rft_id=https%3A%2F%2Fwww.iso.org%2Fforeword-supplementary-information.html&rfr_id=info%3Asid%2Fen.wikipedia.org%3AISO+13485" class="Z3988"></span></span> </li> <li id="cite_note-2"><span class="mw-cite-backlink"><b><a href="#cite_ref-2">^</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_ics/catalogue_detail_ics.htm?csnumber=59752">"ISO 13485:2016 - Medical devices -- Quality management systems -- Requirements for regulatory purposes"</a>. <i>www.iso.org</i><span class="reference-accessdate">. Retrieved <span class="nowrap">2016-03-24</span></span>.</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+13485%3A2016+-+Medical+devices+--+Quality+management+systems+--+Requirements+for+regulatory+purposes&rft_id=http%3A%2F%2Fwww.iso.org%2Fiso%2Fhome%2Fstore%2Fcatalogue_ics%2Fcatalogue_detail_ics.htm%3Fcsnumber%3D59752&rfr_id=info%3Asid%2Fen.wikipedia.org%3AISO+13485" class="Z3988"></span></span> </li> <li id="cite_note-3"><span class="mw-cite-backlink"><b><a href="#cite_ref-3">^</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.bsiamerica.com/en-us/Assessment-and-Certification-services/Management-systems/Standards-and-schemes/ISO-TS-16949/ISOTS-169492002-Questions-and-answers/">"IATF 16949:2016 Automotive Quality Management System - BSI America - BSI America"</a>. <i>www.bsiamerica.com</i>.</cite><span title="ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=unknown&rft.jtitle=www.bsiamerica.com&rft.atitle=IATF+16949%3A2016+Automotive+Quality+Management+System+-+BSI+America+-+BSI+America&rft_id=http%3A%2F%2Fwww.bsiamerica.com%2Fen-us%2FAssessment-and-Certification-services%2FManagement-systems%2FStandards-and-schemes%2FISO-TS-16949%2FISOTS-169492002-Questions-and-answers%2F&rfr_id=info%3Asid%2Fen.wikipedia.org%3AISO+13485" class="Z3988"></span></span> </li> <li id="cite_note-4"><span class="mw-cite-backlink"><b><a href="#cite_ref-4">^</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.qualitymag.com/articles/85096-understanding-iso-13485">"Understanding ISO 13485"</a>.</cite><span title="ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=unknown&rft.btitle=Understanding+ISO+13485&rft_id=http%3A%2F%2Fwww.qualitymag.com%2Farticles%2F85096-understanding-iso-13485&rfr_id=info%3Asid%2Fen.wikipedia.org%3AISO+13485" class="Z3988"></span></span> </li> <li id="cite_note-5"><span class="mw-cite-backlink"><b><a href="#cite_ref-5">^</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://web.archive.org/web/20090201170835/http://ec.europa.eu/enterprise/newapproach/standardization/harmstds/reflist/meddevic.html">"Summary list of titles and references of harmonised standards related to medical devices - DG Enterprise & Industry. European Commission"</a>. Archived from <a rel="nofollow" class="external text" href="http://ec.europa.eu/enterprise/newapproach/standardization/harmstds/reflist/meddevic.html">the original</a> on 2009-02-01.</cite><span title="ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=unknown&rft.btitle=Summary+list+of+titles+and+references+of+harmonised+standards+related+to+medical+devices+-+DG+Enterprise+%26+Industry.+European+Commission&rft_id=http%3A%2F%2Fec.europa.eu%2Fenterprise%2Fnewapproach%2Fstandardization%2Fharmstds%2Freflist%2Fmeddevic.html&rfr_id=info%3Asid%2Fen.wikipedia.org%3AISO+13485" class="Z3988"></span></span> </li> <li id="cite_note-6"><span class="mw-cite-backlink"><b><a href="#cite_ref-6">^</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.ghtf.org">"GHTF is no longer in operation"</a>. <i>www.ghtf.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.ghtf.org&rft.atitle=GHTF+is+no+longer+in+operation&rft_id=http%3A%2F%2Fwww.ghtf.org&rfr_id=info%3Asid%2Fen.wikipedia.org%3AISO+13485" 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 class="citation web cs1"><a rel="nofollow" class="external text" href="http://www.imdrf.org/">"International Medical Device Regulators Forum"</a>. <i>www.imdrf.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.imdrf.org&rft.atitle=International+Medical+Device+Regulators+Forum&rft_id=http%3A%2F%2Fwww.imdrf.org%2F&rfr_id=info%3Asid%2Fen.wikipedia.org%3AISO+13485" 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"><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.cenelec.eu/dyn/www/f?p=104:110:3534353077576903::::FSP_ORG_ID,FSP_PROJECT,FSP_LANG_ID:10384,24011,25">"CENELEC - Standards Development - List of Technical Bodies -"</a>. <i>www.cenelec.eu</i>.</cite><span title="ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=unknown&rft.jtitle=www.cenelec.eu&rft.atitle=CENELEC+-+Standards+Development+-+List+of+Technical+Bodies+-&rft_id=http%3A%2F%2Fwww.cenelec.eu%2Fdyn%2Fwww%2Ff%3Fp%3D104%3A110%3A3534353077576903%3A%3A%3A%3AFSP_ORG_ID%2CFSP_PROJECT%2CFSP_LANG_ID%3A10384%2C24011%2C25&rfr_id=info%3Asid%2Fen.wikipedia.org%3AISO+13485" class="Z3988"></span><sup class="noprint Inline-Template"><span style="white-space: nowrap;">[<i><a href="/wiki/Wikipedia:Link_rot" title="Wikipedia:Link rot"><span title=" Dead link tagged August 2024">permanent dead link</span></a></i><span style="visibility:hidden; color:transparent; padding-left:2px">‍</span>]</span></sup></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"><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.dof.gob.mx/nota_detalle.php?codigo=5272051&fecha=11/10/2012">"NORMA Oficial Mexicana NOM-241-SSA1-2012, Buenas prácticas de fabricación para establecimientos dedicados a la fabricación de dispositivos médicos"</a>. <i>www.dof.gob.mx</i><span class="reference-accessdate">. Retrieved <span class="nowrap">19 October</span> 2017</span>.</cite><span title="ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=unknown&rft.jtitle=www.dof.gob.mx&rft.atitle=NORMA+Oficial+Mexicana+NOM-241-SSA1-2012%2C+Buenas+pr%C3%A1cticas+de+fabricaci%C3%B3n+para+establecimientos+dedicados+a+la+fabricaci%C3%B3n+de+dispositivos+m%C3%A9dicos.&rft_id=http%3A%2F%2Fwww.dof.gob.mx%2Fnota_detalle.php%3Fcodigo%3D5272051%26fecha%3D11%2F10%2F2012&rfr_id=info%3Asid%2Fen.wikipedia.org%3AISO+13485" class="Z3988"></span></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_13485&action=edit&section=6" 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="http://www.tuv-sud.co.uk/uk-en/industry/healthcare-medical-devices/quality-management-amp-quality-control/iso-13485-quality-management-system-for-medical-devices">Guide to ISO 13485</a></li> <li><a rel="nofollow" class="external text" href="https://www.iso.org/standard/59752.html">ISO 13485 Standard: Medical devices — Quality management systems</a>: ISO Website</li> <li><a rel="nofollow" class="external text" href="https://ec.europa.eu/health/md_sector/overview_en">Overview, guidance and regulatory compliance for EU medical device manufacturers</a></li> <li><a rel="nofollow" class="external text" href="https://www.ecfr.gov/cgi-bin/text-idx?SID=8e7f1733686fd406a963563feebb2a68&mc=true&tpl=/ecfrbrowse/Title21/21cfr821_main_02.tpl">CFR - Code of Federal Regulations Title 21, Part 821</a>, <a href="/wiki/Food_and_Drug_Administration" title="Food and Drug Administration">Food and Drug Administration</a>'s Quality System Regulation</li></ul> <div class="navbox-styles"><style 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4em}html.skin-theme-clientpref-night .mw-parser-output .navbar li a abbr{color:var(--color-base)!important}@media(prefers-color-scheme:dark){html.skin-theme-clientpref-os .mw-parser-output .navbar li a abbr{color:var(--color-base)!important}}@media print{.mw-parser-output .navbar{display:none!important}}</style><div class="navbar plainlinks hlist navbar-mini"><ul><li class="nv-view"><a href="/wiki/Template:ISO_standards" title="Template:ISO standards"><abbr title="View this template">v</abbr></a></li><li class="nv-talk"><a href="/wiki/Template_talk:ISO_standards" title="Template talk:ISO standards"><abbr title="Discuss this template">t</abbr></a></li><li class="nv-edit"><a href="/wiki/Special:EditPage/Template:ISO_standards" title="Special:EditPage/Template:ISO standards"><abbr title="Edit this template">e</abbr></a></li></ul></div><div id="ISO_standards_by_standard_number" style="font-size:114%;margin:0 4em"><a href="/wiki/International_Organization_for_Standardization" title="International Organization for Standardization">ISO</a> standards <span 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 class="mw-selflink selflink">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 href="/wiki/ISO_14971" title="ISO 14971">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> 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