CINXE.COM

<!DOCTYPE html> <html class="client-nojs vector-feature-language-in-header-enabled vector-feature-language-in-main-page-header-disabled vector-feature-sticky-header-disabled vector-feature-page-tools-pinned-disabled vector-feature-toc-pinned-clientpref-1 vector-feature-main-menu-pinned-disabled vector-feature-limited-width-clientpref-1 vector-feature-limited-width-content-enabled vector-feature-custom-font-size-clientpref-1 vector-feature-appearance-pinned-clientpref-1 vector-feature-night-mode-disabled skin-theme-clientpref-day vector-toc-available" lang="sv" dir="ltr"> <head> <meta charset="UTF-8"> <title>ISO 13485 – Wikipedia</title> <script>(function(){var className="client-js vector-feature-language-in-header-enabled vector-feature-language-in-main-page-header-disabled vector-feature-sticky-header-disabled vector-feature-page-tools-pinned-disabled vector-feature-toc-pinned-clientpref-1 vector-feature-main-menu-pinned-disabled vector-feature-limited-width-clientpref-1 vector-feature-limited-width-content-enabled vector-feature-custom-font-size-clientpref-1 vector-feature-appearance-pinned-clientpref-1 vector-feature-night-mode-disabled skin-theme-clientpref-day vector-toc-available";var cookie=document.cookie.match(/(?:^|; )svwikimwclientpreferences=([^;]+)/);if(cookie){cookie[1].split('%2C').forEach(function(pref){className=className.replace(new RegExp('(^| )'+pref.replace(/-clientpref-\w+$|[^\w-]+/g,'')+'-clientpref-\\w+( |$)'),'$1'+pref+'$2');});}document.documentElement.className=className;}());RLCONF={"wgBreakFrames":false,"wgSeparatorTransformTable":[",\t."," \t,"],"wgDigitTransformTable":["",""], "wgDefaultDateFormat":"dmy","wgMonthNames":["","januari","februari","mars","april","maj","juni","juli","augusti","september","oktober","november","december"],"wgRequestId":"147e941a-e00b-45ff-9f55-acfdb773b1ec","wgCanonicalNamespace":"","wgCanonicalSpecialPageName":false,"wgNamespaceNumber":0,"wgPageName":"ISO_13485","wgTitle":"ISO 13485","wgCurRevisionId":50523842,"wgRevisionId":50523842,"wgArticleId":655565,"wgIsArticle":true,"wgIsRedirect":false,"wgAction":"view","wgUserName":null,"wgUserGroups":["*"],"wgCategories":["Artiklar som behöver källor 2022-04","Alla artiklar märkta med mallen källor","Alla artiklar som behöver källor","ISO-standarder","Medicinsk litteratur","Patientsäkerhet"],"wgPageViewLanguage":"sv","wgPageContentLanguage":"sv","wgPageContentModel":"wikitext","wgRelevantPageName":"ISO_13485","wgRelevantArticleId":655565,"wgIsProbablyEditable":true,"wgRelevantPageIsProbablyEditable":true,"wgRestrictionEdit":[],"wgRestrictionMove":[],"wgNoticeProject":"wikipedia", "wgCiteReferencePreviewsActive":true,"wgMediaViewerOnClick":true,"wgMediaViewerEnabledByDefault":true,"wgPopupsFlags":0,"wgVisualEditor":{"pageLanguageCode":"sv","pageLanguageDir":"ltr","pageVariantFallbacks":"sv"},"wgMFDisplayWikibaseDescriptions":{"search":true,"watchlist":true,"tagline":true,"nearby":true},"wgWMESchemaEditAttemptStepOversample":false,"wgWMEPageLength":2000,"wgRelatedArticlesCompat":[],"wgCentralAuthMobileDomain":false,"wgEditSubmitButtonLabelPublish":true,"wgULSPosition":"interlanguage","wgULSisCompactLinksEnabled":false,"wgVector2022LanguageInHeader":true,"wgULSisLanguageSelectorEmpty":false,"wgWikibaseItemId":"Q1654689","wgCheckUserClientHintsHeadersJsApi":["brands","architecture","bitness","fullVersionList","mobile","model","platform","platformVersion"],"GEHomepageSuggestedEditsEnableTopics":true,"wgGETopicsMatchModeEnabled":false,"wgGEStructuredTaskRejectionReasonTextInputEnabled":false,"wgGELevelingUpEnabledForUser":false};RLSTATE={"ext.gadget.babel":"ready", "ext.gadget.geo":"ready","ext.gadget.warnings":"ready","ext.gadget.tags":"ready","ext.gadget.error":"ready","ext.gadget.referenser":"ready","ext.gadget.printonly":"ready","ext.gadget.tables":"ready","ext.gadget.toccolours":"ready","ext.gadget.smallTagFontSize":"ready","ext.gadget.videoPlayButton":"ready","ext.globalCssJs.user.styles":"ready","site.styles":"ready","user.styles":"ready","ext.globalCssJs.user":"ready","user":"ready","user.options":"loading","skins.vector.search.codex.styles":"ready","skins.vector.styles":"ready","skins.vector.icons":"ready","ext.wikimediamessages.styles":"ready","ext.visualEditor.desktopArticleTarget.noscript":"ready","ext.uls.interlanguage":"ready","wikibase.client.init":"ready","ext.wikimediaBadges":"ready"};RLPAGEMODULES=["site","mediawiki.page.ready","skins.vector.js","ext.centralNotice.geoIP","ext.centralNotice.startUp","ext.gadget.editsection0","ext.gadget.ProtectionIndicators","ext.gadget.GeoboxLocatorMulti","ext.gadget.InterwikiBadges", "ext.gadget.collapsibleTables","ext.gadget.NewSection","ext.gadget.ExkluderaRobotskapadeSidor","ext.gadget.Nearby","ext.gadget.InterProjectLinks","ext.gadget.cgiircbox","ext.gadget.withJS","ext.gadget.CommonsFileLinks","ext.gadget.tableSorterCollation","ext.urlShortener.toolbar","ext.centralauth.centralautologin","mmv.bootstrap","ext.popups","ext.visualEditor.desktopArticleTarget.init","ext.visualEditor.targetLoader","ext.echo.centralauth","ext.eventLogging","ext.wikimediaEvents","ext.navigationTiming","ext.uls.interface","ext.cx.eventlogging.campaigns","ext.cx.uls.quick.actions","wikibase.client.vector-2022","ext.checkUser.clientHints","ext.growthExperiments.SuggestedEditSession","wikibase.sidebar.tracking"];</script> <script>(RLQ=window.RLQ||[]).push(function(){mw.loader.impl(function(){return["user.options@12s5i",function($,jQuery,require,module){mw.user.tokens.set({"patrolToken":"+\\","watchToken":"+\\","csrfToken":"+\\"}); }];});});</script> <link rel="stylesheet" href="/w/load.php?lang=sv&modules=ext.uls.interlanguage%7Cext.visualEditor.desktopArticleTarget.noscript%7Cext.wikimediaBadges%7Cext.wikimediamessages.styles%7Cskins.vector.icons%2Cstyles%7Cskins.vector.search.codex.styles%7Cwikibase.client.init&only=styles&skin=vector-2022"> <script async="" src="/w/load.php?lang=sv&modules=startup&only=scripts&raw=1&skin=vector-2022"></script> <meta name="ResourceLoaderDynamicStyles" content=""> <link rel="stylesheet" href="/w/load.php?lang=sv&modules=ext.gadget.babel%2Cerror%2Cgeo%2Cprintonly%2Creferenser%2CsmallTagFontSize%2Ctables%2Ctags%2Ctoccolours%2CvideoPlayButton%2Cwarnings&only=styles&skin=vector-2022"> <link rel="stylesheet" href="/w/load.php?lang=sv&modules=site.styles&only=styles&skin=vector-2022"> <meta name="generator" content="MediaWiki 1.44.0-wmf.4"> <meta name="referrer" content="origin"> <meta name="referrer" content="origin-when-cross-origin"> <meta name="robots" content="noindex,nofollow,max-image-preview:standard"> <meta name="format-detection" content="telephone=no"> <meta name="viewport" content="width=1120"> <meta property="og:title" content="ISO 13485 – Wikipedia"> <meta property="og:type" content="website"> <link rel="preconnect" href="//upload.wikimedia.org"> <link rel="alternate" media="only screen and (max-width: 640px)" href="//sv.m.wikipedia.org/wiki/ISO_13485"> <link rel="alternate" type="application/x-wiki" title="Redigera" href="/w/index.php?title=ISO_13485&action=edit"> <link rel="apple-touch-icon" href="/static/apple-touch/wikipedia.png"> <link rel="icon" href="/static/favicon/wikipedia.ico"> <link rel="search" type="application/opensearchdescription+xml" href="/w/rest.php/v1/search" title="Wikipedia (sv)"> <link rel="EditURI" type="application/rsd+xml" href="//sv.wikipedia.org/w/api.php?action=rsd"> <link rel="canonical" href="https://sv.wikipedia.org/wiki/ISO_13485"> <link rel="license" href="https://creativecommons.org/licenses/by-sa/4.0/deed.sv"> <link rel="alternate" type="application/atom+xml" title="Wikipedia Atom-flöde" href="/w/index.php?title=Special:Senaste_%C3%A4ndringar&feed=atom"> <link rel="dns-prefetch" href="//meta.wikimedia.org" /> <link rel="dns-prefetch" href="//login.wikimedia.org"> </head> <body class="skin--responsive skin-vector skin-vector-search-vue mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-0 ns-subject mw-editable page-ISO_13485 rootpage-ISO_13485 skin-vector-2022 action-view"><a class="mw-jump-link" href="#bodyContent">Hoppa till innehållet</a> <div class="vector-header-container"> <header class="vector-header mw-header"> <div class="vector-header-start"> <nav class="vector-main-menu-landmark" aria-label="Webbplats"> <div id="vector-main-menu-dropdown" class="vector-dropdown vector-main-menu-dropdown vector-button-flush-left vector-button-flush-right" > <input type="checkbox" id="vector-main-menu-dropdown-checkbox" role="button" aria-haspopup="true" data-event-name="ui.dropdown-vector-main-menu-dropdown" class="vector-dropdown-checkbox " aria-label="Huvudmeny" > <label id="vector-main-menu-dropdown-label" for="vector-main-menu-dropdown-checkbox" class="vector-dropdown-label cdx-button cdx-button--fake-button cdx-button--fake-button--enabled cdx-button--weight-quiet cdx-button--icon-only " aria-hidden="true" ><span class="vector-icon mw-ui-icon-menu mw-ui-icon-wikimedia-menu"></span> <span class="vector-dropdown-label-text">Huvudmeny</span> </label> <div class="vector-dropdown-content"> <div id="vector-main-menu-unpinned-container" class="vector-unpinned-container"> <div id="vector-main-menu" class="vector-main-menu vector-pinnable-element"> <div class="vector-pinnable-header vector-main-menu-pinnable-header vector-pinnable-header-unpinned" data-feature-name="main-menu-pinned" data-pinnable-element-id="vector-main-menu" data-pinned-container-id="vector-main-menu-pinned-container" data-unpinned-container-id="vector-main-menu-unpinned-container" > <div class="vector-pinnable-header-label">Huvudmeny</div> <button class="vector-pinnable-header-toggle-button vector-pinnable-header-pin-button" data-event-name="pinnable-header.vector-main-menu.pin">flytta till sidofältet</button> <button class="vector-pinnable-header-toggle-button vector-pinnable-header-unpin-button" data-event-name="pinnable-header.vector-main-menu.unpin">dölj</button> </div> <div id="p-navigation" class="vector-menu mw-portlet mw-portlet-navigation" > <div class="vector-menu-heading"> Navigering </div> <div class="vector-menu-content"> <ul class="vector-menu-content-list"> <li id="n-mainpage-description" class="mw-list-item"><a href="/wiki/Portal:Huvudsida" title="Besök huvudsidan [z]" accesskey="z"><span>Huvudsida</span></a></li><li id="n-Introduktion" class="mw-list-item"><a href="/wiki/Wikipedia:Introduktion"><span>Introduktion</span></a></li><li id="n-portal" class="mw-list-item"><a href="/wiki/Wikipedia:Deltagarportalen" title="Om projektet, vad du kan göra, var man kan hitta saker"><span>Deltagarportalen</span></a></li><li id="n-Bybrunnen" class="mw-list-item"><a href="/wiki/Wikipedia:Bybrunnen"><span>Bybrunnen</span></a></li><li id="n-recentchanges" class="mw-list-item"><a href="/wiki/Special:Senaste_%C3%A4ndringar" title="Lista över de senaste ändringarna på wikin [r]" accesskey="r"><span>Senaste ändringarna</span></a></li><li id="n-randompage" class="mw-list-item"><a href="/wiki/Special:Slumpsida" title="Gå till en slumpmässigt vald sida [x]" accesskey="x"><span>Slumpartikel</span></a></li><li id="n-filuppladdning" class="mw-list-item"><a href="//commons.wikimedia.org/wiki/Special:UploadWizard" title="Ladda upp filer till Wikimedia Commons"><span>Ladda upp filer</span></a></li><li id="n-Kontakta-Wikipedia" class="mw-list-item"><a href="/wiki/Wikipedia:Kontakt"><span>Kontakta Wikipedia</span></a></li><li id="n-help" class="mw-list-item"><a href="/wiki/Wikipedia:Hj%C3%A4lp" title="Platsen där du hittar hjälp"><span>Hjälp</span></a></li> </ul> </div> </div> </div> </div> </div> </div> </nav> <a href="/wiki/Portal:Huvudsida" class="mw-logo"> <img class="mw-logo-icon" src="/static/images/icons/wikipedia.png" alt="" aria-hidden="true" height="50" width="50"> <span class="mw-logo-container skin-invert"> <img class="mw-logo-wordmark" alt="Wikipedia" src="/static/images/mobile/copyright/wikipedia-wordmark-en.svg" style="width: 7.5em; height: 1.125em;"> <img class="mw-logo-tagline" alt="" src="/static/images/mobile/copyright/wikipedia-tagline-sv.svg" width="120" height="13" style="width: 7.5em; height: 0.8125em;"> </span> </a> </div> <div class="vector-header-end"> <div id="p-search" role="search" class="vector-search-box-vue vector-search-box-collapses vector-search-box-show-thumbnail vector-search-box-auto-expand-width vector-search-box"> <a href="/wiki/Special:S%C3%B6k" class="cdx-button cdx-button--fake-button cdx-button--fake-button--enabled cdx-button--weight-quiet cdx-button--icon-only search-toggle" title="Sök i svenskspråkiga Wikipedia [f]" accesskey="f"><span class="vector-icon mw-ui-icon-search mw-ui-icon-wikimedia-search"></span> <span>Sök</span> </a> <div class="vector-typeahead-search-container"> <div class="cdx-typeahead-search cdx-typeahead-search--show-thumbnail cdx-typeahead-search--auto-expand-width"> <form action="/w/index.php" id="searchform" class="cdx-search-input cdx-search-input--has-end-button"> <div id="simpleSearch" class="cdx-search-input__input-wrapper" data-search-loc="header-moved"> <div class="cdx-text-input cdx-text-input--has-start-icon"> <input class="cdx-text-input__input" type="search" name="search" placeholder="Sök på Wikipedia" aria-label="Sök på Wikipedia" autocapitalize="sentences" title="Sök i svenskspråkiga Wikipedia [f]" accesskey="f" id="searchInput" > <span class="cdx-text-input__icon cdx-text-input__start-icon"></span> </div> <input type="hidden" name="title" value="Special:Sök"> </div> <button class="cdx-button cdx-search-input__end-button">Sök</button> </form> </div> </div> </div> <nav class="vector-user-links vector-user-links-wide" aria-label="Personliga verktyg"> <div class="vector-user-links-main"> <div id="p-vector-user-menu-preferences" class="vector-menu mw-portlet emptyPortlet" > <div class="vector-menu-content"> <ul class="vector-menu-content-list"> </ul> </div> </div> <div id="p-vector-user-menu-userpage" class="vector-menu mw-portlet emptyPortlet" > <div class="vector-menu-content"> <ul class="vector-menu-content-list"> </ul> </div> </div> <nav class="vector-appearance-landmark" aria-label="Utseende"> <div id="vector-appearance-dropdown" class="vector-dropdown " title="Ändra utseendet på sidans teckenstorlek, bredd och färg" > <input type="checkbox" id="vector-appearance-dropdown-checkbox" role="button" aria-haspopup="true" data-event-name="ui.dropdown-vector-appearance-dropdown" class="vector-dropdown-checkbox " aria-label="Utseende" > <label id="vector-appearance-dropdown-label" for="vector-appearance-dropdown-checkbox" class="vector-dropdown-label cdx-button cdx-button--fake-button cdx-button--fake-button--enabled cdx-button--weight-quiet cdx-button--icon-only " aria-hidden="true" ><span class="vector-icon mw-ui-icon-appearance mw-ui-icon-wikimedia-appearance"></span> <span class="vector-dropdown-label-text">Utseende</span> </label> <div class="vector-dropdown-content"> <div id="vector-appearance-unpinned-container" class="vector-unpinned-container"> </div> </div> </div> </nav> <div id="p-vector-user-menu-notifications" class="vector-menu mw-portlet emptyPortlet" > <div class="vector-menu-content"> <ul class="vector-menu-content-list"> </ul> </div> </div> <div id="p-vector-user-menu-overflow" class="vector-menu mw-portlet" > <div class="vector-menu-content"> <ul class="vector-menu-content-list"> <li id="pt-sitesupport-2" class="user-links-collapsible-item mw-list-item user-links-collapsible-item"><a data-mw="interface" href="//donate.wikimedia.org/wiki/Special:FundraiserRedirector?utm_source=donate&utm_medium=sidebar&utm_campaign=C13_sv.wikipedia.org&uselang=sv" class=""><span>Stöd Wikipedia</span></a> </li> <li id="pt-createaccount-2" class="user-links-collapsible-item mw-list-item user-links-collapsible-item"><a data-mw="interface" href="/w/index.php?title=Special:Skapa_konto&returnto=ISO+13485&returntoquery=section%3D2%26veaction%3Dedit%26redirect%3Dno" title="Du uppmuntras att skapa ett konto och logga in, men det är inte obligatoriskt" class=""><span>Skapa konto</span></a> </li> <li id="pt-login-2" class="user-links-collapsible-item mw-list-item user-links-collapsible-item"><a data-mw="interface" href="/w/index.php?title=Special:Inloggning&returnto=ISO+13485&returntoquery=section%3D2%26veaction%3Dedit%26redirect%3Dno" title="Inloggning ger tillgång till fler funktioner för den som vill skriva och redigera artiklar. [o]" accesskey="o" class=""><span>Logga in</span></a> </li> </ul> </div> </div> </div> <div id="vector-user-links-dropdown" class="vector-dropdown vector-user-menu vector-button-flush-right vector-user-menu-logged-out" title="Fler alternativ" > <input type="checkbox" id="vector-user-links-dropdown-checkbox" role="button" aria-haspopup="true" data-event-name="ui.dropdown-vector-user-links-dropdown" class="vector-dropdown-checkbox " aria-label="Personliga verktyg" > <label id="vector-user-links-dropdown-label" for="vector-user-links-dropdown-checkbox" class="vector-dropdown-label cdx-button cdx-button--fake-button cdx-button--fake-button--enabled cdx-button--weight-quiet cdx-button--icon-only " aria-hidden="true" ><span class="vector-icon mw-ui-icon-ellipsis mw-ui-icon-wikimedia-ellipsis"></span> <span class="vector-dropdown-label-text">Personliga verktyg</span> </label> <div class="vector-dropdown-content"> <div id="p-personal" class="vector-menu mw-portlet mw-portlet-personal user-links-collapsible-item" title="Användarmeny" > <div class="vector-menu-content"> <ul class="vector-menu-content-list"> <li id="pt-sitesupport" class="user-links-collapsible-item mw-list-item"><a href="//donate.wikimedia.org/wiki/Special:FundraiserRedirector?utm_source=donate&utm_medium=sidebar&utm_campaign=C13_sv.wikipedia.org&uselang=sv"><span>Stöd Wikipedia</span></a></li><li id="pt-createaccount" class="user-links-collapsible-item mw-list-item"><a href="/w/index.php?title=Special:Skapa_konto&returnto=ISO+13485&returntoquery=section%3D2%26veaction%3Dedit%26redirect%3Dno" title="Du uppmuntras att skapa ett konto och logga in, men det är inte obligatoriskt"><span class="vector-icon mw-ui-icon-userAdd mw-ui-icon-wikimedia-userAdd"></span> <span>Skapa konto</span></a></li><li id="pt-login" class="user-links-collapsible-item mw-list-item"><a href="/w/index.php?title=Special:Inloggning&returnto=ISO+13485&returntoquery=section%3D2%26veaction%3Dedit%26redirect%3Dno" title="Inloggning ger tillgång till fler funktioner för den som vill skriva och redigera artiklar. [o]" accesskey="o"><span class="vector-icon mw-ui-icon-logIn mw-ui-icon-wikimedia-logIn"></span> <span>Logga in</span></a></li> </ul> </div> </div> <div id="p-user-menu-anon-editor" class="vector-menu mw-portlet mw-portlet-user-menu-anon-editor" > <div class="vector-menu-heading"> Sidor för utloggade redigerare <a href="/wiki/Hj%C3%A4lp:Introduktion" aria-label="Läs mer om redigering"><span>läs mer</span></a> </div> <div class="vector-menu-content"> <ul class="vector-menu-content-list"> <li id="pt-anoncontribs" class="mw-list-item"><a href="/wiki/Special:Mina_bidrag" title="En lista över redigeringar från denna IP-adress [y]" accesskey="y"><span>Bidrag</span></a></li><li id="pt-anontalk" class="mw-list-item"><a href="/wiki/Special:Min_diskussion" title="Diskussion om redigeringar från det här IP-numret [n]" accesskey="n"><span>Diskussion</span></a></li> </ul> </div> </div> </div> </div> </nav> </div> </header> </div> <div class="mw-page-container"> <div class="mw-page-container-inner"> <div class="vector-sitenotice-container"> <div id="siteNotice"></div> </div> <div class="vector-column-start"> <div class="vector-main-menu-container"> <div id="mw-navigation"> <nav id="mw-panel" class="vector-main-menu-landmark" aria-label="Webbplats"> <div id="vector-main-menu-pinned-container" class="vector-pinned-container"> </div> </nav> </div> </div> <div class="vector-sticky-pinned-container"> <nav id="mw-panel-toc" aria-label="Innehåll" data-event-name="ui.sidebar-toc" class="mw-table-of-contents-container vector-toc-landmark"> <div id="vector-toc-pinned-container" class="vector-pinned-container"> <div id="vector-toc" class="vector-toc vector-pinnable-element"> <div class="vector-pinnable-header vector-toc-pinnable-header vector-pinnable-header-pinned" data-feature-name="toc-pinned" data-pinnable-element-id="vector-toc" > <h2 class="vector-pinnable-header-label">Innehåll</h2> <button class="vector-pinnable-header-toggle-button vector-pinnable-header-pin-button" data-event-name="pinnable-header.vector-toc.pin">flytta till sidofältet</button> <button class="vector-pinnable-header-toggle-button vector-pinnable-header-unpin-button" data-event-name="pinnable-header.vector-toc.unpin">dölj</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">Inledning</div> </a> </li> <li id="toc-Referenser" class="vector-toc-list-item vector-toc-level-1 vector-toc-list-item-expanded"> <a class="vector-toc-link" href="#Referenser"> <div class="vector-toc-text"> <span class="vector-toc-numb">1</span> <span>Referenser</span> </div> </a> <ul id="toc-Referenser-sublist" class="vector-toc-list"> </ul> </li> <li id="toc-Externa_länkar" class="vector-toc-list-item vector-toc-level-1 vector-toc-list-item-expanded"> <a class="vector-toc-link" href="#Externa_länkar"> <div class="vector-toc-text"> <span class="vector-toc-numb">2</span> <span>Externa länkar</span> </div> </a> <ul id="toc-Externa_länkar-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="Innehåll" 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 " aria-label="Växla innehållsförteckningen" > <label id="vector-page-titlebar-toc-label" for="vector-page-titlebar-toc-checkbox" class="vector-dropdown-label cdx-button cdx-button--fake-button cdx-button--fake-button--enabled cdx-button--weight-quiet cdx-button--icon-only " aria-hidden="true" ><span class="vector-icon mw-ui-icon-listBullet mw-ui-icon-wikimedia-listBullet"></span> <span class="vector-dropdown-label-text">Växla innehållsförteckningen</span> </label> <div class="vector-dropdown-content"> <div id="vector-page-titlebar-toc-unpinned-container" class="vector-unpinned-container"> </div> </div> </div> </nav> <h1 id="firstHeading" class="firstHeading mw-first-heading"><span class="mw-page-title-main">ISO 13485</span></h1> <div id="p-lang-btn" class="vector-dropdown mw-portlet mw-portlet-lang" > <input type="checkbox" id="p-lang-btn-checkbox" role="button" aria-haspopup="true" data-event-name="ui.dropdown-p-lang-btn" class="vector-dropdown-checkbox mw-interlanguage-selector" aria-label="Gå till en artikel på ett annat språk. Tillgänglig på 14 språk" > <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 språk</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 – danska" lang="da" hreflang="da" data-title="ISO 13485" data-language-autonym="Dansk" data-language-local-name="danska" 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 – tyska" lang="de" hreflang="de" data-title="ISO 13485" data-language-autonym="Deutsch" data-language-local-name="tyska" class="interlanguage-link-target"><span>Deutsch</span></a></li><li class="interlanguage-link interwiki-en mw-list-item"><a href="https://en.wikipedia.org/wiki/ISO_13485" title="ISO 13485 – engelska" lang="en" hreflang="en" data-title="ISO 13485" data-language-autonym="English" data-language-local-name="engelska" class="interlanguage-link-target"><span>English</span></a></li><li class="interlanguage-link interwiki-es mw-list-item"><a href="https://es.wikipedia.org/wiki/ISO_13485" title="ISO 13485 – spanska" lang="es" hreflang="es" data-title="ISO 13485" data-language-autonym="Español" data-language-local-name="spanska" 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 – persiska" lang="fa" hreflang="fa" data-title="ایزو ۱۳۴۸۵" data-language-autonym="فارسی" data-language-local-name="persiska" 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 – franska" lang="fr" hreflang="fr" data-title="ISO 13485" data-language-autonym="Français" data-language-local-name="franska" 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 – kroatiska" lang="hr" hreflang="hr" data-title="ISO 13485" data-language-autonym="Hrvatski" data-language-local-name="kroatiska" 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 – indonesiska" lang="id" hreflang="id" data-title="ISO 13485" data-language-autonym="Bahasa Indonesia" data-language-local-name="indonesiska" 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 – italienska" lang="it" hreflang="it" data-title="ISO 13485" data-language-autonym="Italiano" data-language-local-name="italienska" class="interlanguage-link-target"><span>Italiano</span></a></li><li class="interlanguage-link interwiki-ja mw-list-item"><a href="https://ja.wikipedia.org/wiki/ISO_13485" title="ISO 13485 – japanska" lang="ja" hreflang="ja" data-title="ISO 13485" data-language-autonym="日本語" data-language-local-name="japanska" class="interlanguage-link-target"><span>日本語</span></a></li><li class="interlanguage-link interwiki-pl mw-list-item"><a href="https://pl.wikipedia.org/wiki/ISO_13485" title="ISO 13485 – polska" lang="pl" hreflang="pl" data-title="ISO 13485" data-language-autonym="Polski" data-language-local-name="polska" class="interlanguage-link-target"><span>Polski</span></a></li><li class="interlanguage-link interwiki-ru mw-list-item"><a href="https://ru.wikipedia.org/wiki/ISO_13485" title="ISO 13485 – ryska" lang="ru" hreflang="ru" data-title="ISO 13485" data-language-autonym="Русский" data-language-local-name="ryska" class="interlanguage-link-target"><span>Русский</span></a></li><li class="interlanguage-link interwiki-tr mw-list-item"><a href="https://tr.wikipedia.org/wiki/ISO_13485" title="ISO 13485 – turkiska" lang="tr" hreflang="tr" data-title="ISO 13485" data-language-autonym="Türkçe" data-language-local-name="turkiska" class="interlanguage-link-target"><span>Türkçe</span></a></li><li class="interlanguage-link interwiki-yo mw-list-item"><a href="https://yo.wikipedia.org/wiki/ISO_13485" title="ISO 13485 – yoruba" lang="yo" hreflang="yo" data-title="ISO 13485" data-language-autonym="Yorùbá" data-language-local-name="yoruba" class="interlanguage-link-target"><span>Yorùbá</span></a></li> </ul> <div class="after-portlet after-portlet-lang"><span class="wb-langlinks-edit wb-langlinks-link"><a href="https://www.wikidata.org/wiki/Special:EntityPage/Q1654689#sitelinks-wikipedia" title="Redigera interwikilänkar" class="wbc-editpage">Redigera länkar</a></span></div> </div> </div> </div> </header> <div class="vector-page-toolbar"> <div class="vector-page-toolbar-container"> <div id="left-navigation"> <nav aria-label="Namnrymder"> <div id="p-associated-pages" class="vector-menu vector-menu-tabs mw-portlet mw-portlet-associated-pages" > <div class="vector-menu-content"> <ul class="vector-menu-content-list"> <li id="ca-nstab-main" class="selected vector-tab-noicon mw-list-item"><a href="/wiki/ISO_13485" title="Visa innehållssidan [c]" accesskey="c"><span>Artikel</span></a></li><li id="ca-talk" class="vector-tab-noicon mw-list-item"><a href="/wiki/Diskussion:ISO_13485" rel="discussion" title="Diskussion om innehållssidan [t]" accesskey="t"><span>Diskussion</span></a></li> </ul> </div> </div> <div id="vector-variants-dropdown" class="vector-dropdown emptyPortlet" > <input type="checkbox" id="vector-variants-dropdown-checkbox" role="button" aria-haspopup="true" data-event-name="ui.dropdown-vector-variants-dropdown" class="vector-dropdown-checkbox " aria-label="Ändra språkvariant" > <label id="vector-variants-dropdown-label" for="vector-variants-dropdown-checkbox" class="vector-dropdown-label cdx-button cdx-button--fake-button cdx-button--fake-button--enabled cdx-button--weight-quiet" aria-hidden="true" ><span class="vector-dropdown-label-text">svenska</span> </label> <div class="vector-dropdown-content"> <div id="p-variants" class="vector-menu mw-portlet mw-portlet-variants emptyPortlet" > <div class="vector-menu-content"> <ul class="vector-menu-content-list"> </ul> </div> </div> </div> </div> </nav> </div> <div id="right-navigation" class="vector-collapsible"> <nav aria-label="Visningar"> <div id="p-views" class="vector-menu vector-menu-tabs mw-portlet mw-portlet-views" > <div class="vector-menu-content"> <ul class="vector-menu-content-list"> <li id="ca-view" class="selected vector-tab-noicon mw-list-item"><a href="/wiki/ISO_13485"><span>Läs</span></a></li><li id="ca-ve-edit" class="vector-tab-noicon mw-list-item"><a href="/w/index.php?title=ISO_13485&veaction=edit" title="Redigera denna sida [v]" accesskey="v"><span>Redigera</span></a></li><li id="ca-edit" class="collapsible vector-tab-noicon mw-list-item"><a href="/w/index.php?title=ISO_13485&action=edit" title="Redigera wikitexten för den här sidan [e]" accesskey="e"><span>Redigera wikitext</span></a></li><li id="ca-history" class="vector-tab-noicon mw-list-item"><a href="/w/index.php?title=ISO_13485&action=history" title="Tidigare versioner av sidan [h]" accesskey="h"><span>Visa historik</span></a></li> </ul> </div> </div> </nav> <nav class="vector-page-tools-landmark" aria-label="Sidverktyg"> <div id="vector-page-tools-dropdown" class="vector-dropdown vector-page-tools-dropdown" > <input type="checkbox" id="vector-page-tools-dropdown-checkbox" role="button" aria-haspopup="true" data-event-name="ui.dropdown-vector-page-tools-dropdown" class="vector-dropdown-checkbox " aria-label="Verktyg" > <label id="vector-page-tools-dropdown-label" for="vector-page-tools-dropdown-checkbox" class="vector-dropdown-label cdx-button cdx-button--fake-button cdx-button--fake-button--enabled cdx-button--weight-quiet" aria-hidden="true" ><span class="vector-dropdown-label-text">Verktyg</span> </label> <div class="vector-dropdown-content"> <div id="vector-page-tools-unpinned-container" class="vector-unpinned-container"> <div id="vector-page-tools" class="vector-page-tools vector-pinnable-element"> <div class="vector-pinnable-header vector-page-tools-pinnable-header vector-pinnable-header-unpinned" data-feature-name="page-tools-pinned" data-pinnable-element-id="vector-page-tools" data-pinned-container-id="vector-page-tools-pinned-container" data-unpinned-container-id="vector-page-tools-unpinned-container" > <div class="vector-pinnable-header-label">Verktyg</div> <button class="vector-pinnable-header-toggle-button vector-pinnable-header-pin-button" data-event-name="pinnable-header.vector-page-tools.pin">flytta till sidofältet</button> <button class="vector-pinnable-header-toggle-button vector-pinnable-header-unpin-button" data-event-name="pinnable-header.vector-page-tools.unpin">dölj</button> </div> <div id="p-cactions" class="vector-menu mw-portlet mw-portlet-cactions emptyPortlet vector-has-collapsible-items" title="Fler alternativ" > <div class="vector-menu-heading"> Åtgärder </div> <div class="vector-menu-content"> <ul class="vector-menu-content-list"> <li id="ca-more-view" class="selected vector-more-collapsible-item mw-list-item"><a href="/wiki/ISO_13485"><span>Läs</span></a></li><li id="ca-more-ve-edit" class="vector-more-collapsible-item mw-list-item"><a href="/w/index.php?title=ISO_13485&veaction=edit" title="Redigera denna sida [v]" accesskey="v"><span>Redigera</span></a></li><li id="ca-more-edit" class="collapsible vector-more-collapsible-item mw-list-item"><a href="/w/index.php?title=ISO_13485&action=edit" title="Redigera wikitexten för den här sidan [e]" accesskey="e"><span>Redigera wikitext</span></a></li><li id="ca-more-history" class="vector-more-collapsible-item mw-list-item"><a href="/w/index.php?title=ISO_13485&action=history"><span>Visa historik</span></a></li> </ul> </div> </div> <div id="p-tb" class="vector-menu mw-portlet mw-portlet-tb" > <div class="vector-menu-heading"> Allmänt </div> <div class="vector-menu-content"> <ul class="vector-menu-content-list"> <li id="t-whatlinkshere" class="mw-list-item"><a href="/wiki/Special:L%C3%A4nkar_hit/ISO_13485" title="Lista över alla wikisidor som länkar hit [j]" accesskey="j"><span>Sidor som länkar hit</span></a></li><li id="t-recentchangeslinked" class="mw-list-item"><a href="/wiki/Special:Senaste_relaterade_%C3%A4ndringar/ISO_13485" rel="nofollow" title="Visa senaste ändringarna av sidor som den här sidan länkar till [k]" accesskey="k"><span>Relaterade ändringar</span></a></li><li id="t-specialpages" class="mw-list-item"><a href="/wiki/Special:Specialsidor" title="Lista över alla specialsidor [q]" accesskey="q"><span>Specialsidor</span></a></li><li id="t-permalink" class="mw-list-item"><a href="/w/index.php?title=ISO_13485&oldid=50523842" title="Permanent länk till den här versionen av sidan"><span>Permanent länk</span></a></li><li id="t-info" class="mw-list-item"><a href="/w/index.php?title=ISO_13485&action=info" title="Mer information om denna sida"><span>Sidinformation</span></a></li><li id="t-cite" class="mw-list-item"><a href="/w/index.php?title=Special:Citera&page=ISO_13485&id=50523842&wpFormIdentifier=titleform" title="Information om hur den här artikeln kan användas som referens"><span>Använd som referens</span></a></li><li id="t-urlshortener" class="mw-list-item"><a href="/w/index.php?title=Special:UrlShortener&url=https%3A%2F%2Fsv.wikipedia.org%2Fw%2Findex.php%3Ftitle%3DISO_13485%26section%3D2%26veaction%3Dedit"><span>Hämta förkortad url</span></a></li><li id="t-urlshortener-qrcode" class="mw-list-item"><a href="/w/index.php?title=Special:QrCode&url=https%3A%2F%2Fsv.wikipedia.org%2Fw%2Findex.php%3Ftitle%3DISO_13485%26section%3D2%26veaction%3Dedit"><span>Ladda ner QR-kod</span></a></li> </ul> </div> </div> <div id="p-coll-print_export" class="vector-menu mw-portlet mw-portlet-coll-print_export" > <div class="vector-menu-heading"> Skriv ut/exportera </div> <div class="vector-menu-content"> <ul class="vector-menu-content-list"> <li id="coll-create_a_book" class="mw-list-item"><a href="/w/index.php?title=Special:Bok&bookcmd=book_creator&referer=ISO+13485"><span>Skapa en bok</span></a></li><li id="coll-download-as-rl" class="mw-list-item"><a href="/w/index.php?title=Special:DownloadAsPdf&page=ISO_13485&action=show-download-screen"><span>Ladda ned som PDF</span></a></li><li id="t-print" class="mw-list-item"><a href="/w/index.php?title=ISO_13485&printable=yes" title="Utskriftsvänlig version av den här sidan [p]" accesskey="p"><span>Utskriftsvänlig version</span></a></li> </ul> </div> </div> <div id="p-wikibase-otherprojects" class="vector-menu mw-portlet mw-portlet-wikibase-otherprojects" > <div class="vector-menu-heading"> På andra projekt </div> <div class="vector-menu-content"> <ul class="vector-menu-content-list"> <li id="t-wikibase" class="wb-otherproject-link wb-otherproject-wikibase-dataitem mw-list-item"><a href="https://www.wikidata.org/wiki/Special:EntityPage/Q1654689" title="Länk till anslutet databasobjekt [g]" accesskey="g"><span>Wikidata-objekt</span></a></li> </ul> </div> </div> </div> </div> </div> </div> </nav> </div> </div> </div> <div class="vector-column-end"> <div class="vector-sticky-pinned-container"> <nav class="vector-page-tools-landmark" aria-label="Sidverktyg"> <div id="vector-page-tools-pinned-container" class="vector-pinned-container"> </div> </nav> <nav class="vector-appearance-landmark" aria-label="Utseende"> <div id="vector-appearance-pinned-container" class="vector-pinned-container"> <div id="vector-appearance" class="vector-appearance vector-pinnable-element"> <div class="vector-pinnable-header vector-appearance-pinnable-header vector-pinnable-header-pinned" data-feature-name="appearance-pinned" data-pinnable-element-id="vector-appearance" data-pinned-container-id="vector-appearance-pinned-container" data-unpinned-container-id="vector-appearance-unpinned-container" > <div class="vector-pinnable-header-label">Utseende</div> <button class="vector-pinnable-header-toggle-button vector-pinnable-header-pin-button" data-event-name="pinnable-header.vector-appearance.pin">flytta till sidofältet</button> <button class="vector-pinnable-header-toggle-button vector-pinnable-header-unpin-button" data-event-name="pinnable-header.vector-appearance.unpin">dölj</button> </div> </div> </div> </nav> </div> </div> <div id="bodyContent" class="vector-body" aria-labelledby="firstHeading" data-mw-ve-target-container> <div class="vector-body-before-content"> <div class="mw-indicators"> </div> <div id="siteSub" class="noprint">Från Wikipedia</div> </div> <div id="contentSub"><div id="mw-content-subtitle"></div></div> <div id="mw-content-text" class="mw-body-content"><div class="mw-content-ltr mw-parser-output" lang="sv" dir="ltr"><style data-mw-deduplicate="TemplateStyles:r51224235">.mw-parser-output table.ambox{margin:0 10%;border-collapse:collapse;background:#fbfbfb;border:1px solid #aaa;border-left:10px solid #608ec2}.mw-parser-output table.ambox th.ambox-text,.mw-parser-output table.ambox td.ambox-text{padding:.25em .5em;width:100%}.mw-parser-output table.ambox td.ambox-image{padding:2px 0 2px .5em;text-align:center;vertical-align:middle}.mw-parser-output table.ambox td.ambox-imageright{padding:2px 4px 2px 0;text-align:center;vertical-align:middle}.mw-parser-output table.ambox-notice{border-left:10px solid #608ec2}.mw-parser-output table.ambox-delete,.mw-parser-output table.ambox-serious{border-left:10px solid #b22222}.mw-parser-output table.ambox-content{border-left:10px solid #f28500}.mw-parser-output table.ambox-style{border-left:10px solid #f4c430}.mw-parser-output table.ambox-merge{border-left:10px solid #9932cc}.mw-parser-output table.ambox-protection{border-left:10px solid #bba}.mw-parser-output .ambox+link+.ambox{border-top-width:0}.mw-parser-output .messagebox{border:1px solid #aaaaaa;background-color:#f8f9fa;width:80%;margin:0 auto 1em auto;padding:.2em}.mw-parser-output .messagebox.merge{border:1px solid #c0b8cc;background-color:#f0e5ff;text-align:center}.mw-parser-output .messagebox.cleanup{border:1px solid #9f9fff;background-color:#efefff;text-align:center}.mw-parser-output .messagebox.standard-talk{border:1px solid #c0c090;background-color:#f8eaba}.mw-parser-output .messagebox.nested-talk{border:1px solid #c0c090;background-color:#f8eaba;width:100%;margin:2px 4px}</style><table class="metadata ambox ambox-content" style=""> <tbody><tr> <td class="ambox-image"> <div style="width:52px;"><span typeof="mw:File"><a href="/wiki/Fil:Question_book-4.svg" class="mw-file-description"><img src="//upload.wikimedia.org/wikipedia/commons/thumb/6/64/Question_book-4.svg/40px-Question_book-4.svg.png" decoding="async" width="40" height="31" class="mw-file-element" srcset="//upload.wikimedia.org/wikipedia/commons/thumb/6/64/Question_book-4.svg/60px-Question_book-4.svg.png 1.5x, //upload.wikimedia.org/wikipedia/commons/thumb/6/64/Question_book-4.svg/80px-Question_book-4.svg.png 2x" data-file-width="262" data-file-height="204" /></a></span></div></td> <td class="ambox-text">Den här artikeln <b>behöver <a href="/wiki/Wikipedia:K%C3%A4llh%C3%A4nvisningar" title="Wikipedia:Källhänvisningar">källhänvisningar</a> för att kunna <a href="/wiki/Wikipedia:Verifierbarhet" title="Wikipedia:Verifierbarhet">verifieras</a>.</b> <small>(2022-04)</small> <br /><small>Åtgärda genom att lägga till pålitliga källor (<a href="/wiki/Wikipedia:Introduktion_till_k%C3%A4llh%C3%A4nvisningar" title="Wikipedia:Introduktion till källhänvisningar">gärna som fotnoter</a>). Uppgifter utan källhänvisning kan <a href="/wiki/Mall:K%C3%A4lla_beh%C3%B6vs" title="Mall:Källa behövs">ifrågasättas</a> och tas bort utan att det behöver diskuteras på <a href="/wiki/Diskussion:ISO_13485" title="Diskussion:ISO 13485">diskussionssidan</a>.</small></td> </tr> </tbody></table> <p>Medicintekniska produkter - Ledningssystem för kvalitet - Krav för regulatoriska ändamål. </p><p>Standarden fastställer krav för ett kvalitetsledningssystem för organisationer och aktörer som verkar i en eller flera delar av en medicinteknisk produkts livscykel, bland annat </p> <ul><li>konstruktion och utveckling</li> <li>tillverkning</li> <li>lagring och distribution</li> <li>installation och tillhörande service</li> <li>avveckling.</li></ul> <p>Standarden utgör ett komplement till de tekniska krav som gäller på området, och är tillämplig på alla organisationer som tillhandahåller medicintekniska produkter, oberoende av organisationstyp och storlek. Den omfattar alla centrala inslag som ett kvalitetsledningssystem ska innehålla enligt ISO 9001, samtidigt som kraven är särskilt anpassade efter regelverket för medicintekniska produkter. Vissa krav i ISO 9001 är dock inte förenliga med regelverket för medicintekniska produkter och har därför utelämnats. Standarden är fastställd som svensk standard med beteckningen SS-EN ISO 13485:2016. Till standarden finns också ett tillägg, SS-EN ISO 13485:2016/A11:2021, som innehåller de informativa bilagorna Annex ZA och Annex ZB som visar på relationen mellan standarden och Förordning (EU) 2017/745 om medicintekniska produkter och Förordning (EU) 2017/746 om medicintekniska produkter för in vitro-diagnostik. </p> <div class="mw-heading mw-heading2"><h2 id="Referenser">Referenser</h2><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=ISO_13485&veaction=edit&section=1" title="Redigera avsnitt: Referenser" class="mw-editsection-visualeditor"><span>redigera</span></a><span class="mw-editsection-divider"> | </span><a href="/w/index.php?title=ISO_13485&action=edit&section=1" title="Redigera avsnitts källkod: Referenser"><span>redigera wikitext</span></a><span class="mw-editsection-bracket">]</span></span></div> <p><br /> </p> <div class="mw-heading mw-heading2"><h2 id="Externa_länkar"><span id="Externa_l.C3.A4nkar"></span>Externa länkar</h2><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=ISO_13485&veaction=edit&section=2" title="Redigera avsnitt: Externa länkar" class="mw-editsection-visualeditor"><span>redigera</span></a><span class="mw-editsection-divider"> | </span><a href="/w/index.php?title=ISO_13485&action=edit&section=2" title="Redigera avsnitts källkod: Externa länkar"><span>redigera wikitext</span></a><span class="mw-editsection-bracket">]</span></span></div> <ul><li><a rel="nofollow" class="external text" href="https://www.sis.se/produkter/foretagsorganisation/foretagsorganisation-och-foretagsledning-ledningssystem/ledningssystem/sseniso1348520162/">ISO 13485 på sis.se</a></li> <li><cite style="font-style:normal" class="web"><a rel="nofollow" class="external text" href="https://www.sis.se/standardutveckling/tksidor/tk300399/sistk355/">”Standardutveckling - Kvalitetsledning- och riskhanteringssystem samt andra tillhörande standarder för medicinteknik SIS/TK 355”</a>. <i><span>Svenska institutet för standarder, SIS</span></i><span class="printonly">. <a rel="nofollow" class="external free" href="https://www.sis.se/standardutveckling/tksidor/tk300399/sistk355/">https://www.sis.se/standardutveckling/tksidor/tk300399/sistk355/</a></span><span class="reference-accessdate">. Läst 6 april 2022</span>.</cite><span class="Z3988" title="ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Standardutveckling+-+Kvalitetsledning-+och+riskhanteringssystem+samt+andra+tillh%C3%B6rande+standarder+f%C3%B6r+medicinteknik+SIS%2FTK+355&rft.atitle=Svenska+institutet+f%C3%B6r+standarder%2C+SIS&rft_id=https%3A%2F%2Fwww.sis.se%2Fstandardutveckling%2Ftksidor%2Ftk300399%2Fsistk355%2F&rfr_id=info:sid/en.wikipedia.org:ISO_13485"><span style="display: none;"> </span></span></li></ul>    </div><noscript><img src="https://login.wikimedia.org/wiki/Special:CentralAutoLogin/start?type=1x1" alt="" width="1" height="1" style="border: none; position: absolute;"></noscript> <div class="printfooter" data-nosnippet="">Hämtad från ”<a dir="ltr" href="https://sv.wikipedia.org/w/index.php?title=ISO_13485&oldid=50523842">https://sv.wikipedia.org/w/index.php?title=ISO_13485&oldid=50523842</a>”</div></div> <div id="catlinks" class="catlinks" data-mw="interface"><div id="mw-normal-catlinks" class="mw-normal-catlinks"><a href="/wiki/Wikipedia:Kategorier" title="Wikipedia:Kategorier">Kategorier</a>: <ul><li><a href="/wiki/Kategori:ISO-standarder" title="Kategori:ISO-standarder">ISO-standarder</a></li><li><a href="/wiki/Kategori:Medicinsk_litteratur" title="Kategori:Medicinsk litteratur">Medicinsk litteratur</a></li><li><a href="/wiki/Kategori:Patients%C3%A4kerhet" title="Kategori:Patientsäkerhet">Patientsäkerhet</a></li></ul></div><div id="mw-hidden-catlinks" class="mw-hidden-catlinks mw-hidden-cats-hidden">Dolda kategorier: <ul><li><a href="/wiki/Kategori:Artiklar_som_beh%C3%B6ver_k%C3%A4llor_2022-04" title="Kategori:Artiklar som behöver källor 2022-04">Artiklar som behöver källor 2022-04</a></li><li><a href="/wiki/Kategori:Alla_artiklar_m%C3%A4rkta_med_mallen_k%C3%A4llor" title="Kategori:Alla artiklar märkta med mallen källor">Alla artiklar märkta med mallen källor</a></li><li><a href="/wiki/Kategori:Alla_artiklar_som_beh%C3%B6ver_k%C3%A4llor" title="Kategori:Alla artiklar som behöver källor">Alla artiklar som behöver källor</a></li></ul></div></div> </div> </main> </div> <div class="mw-footer-container"> <footer id="footer" class="mw-footer" > <ul id="footer-info"> <li id="footer-info-lastmod"> Sidan redigerades senast den 26 maj 2022 kl. 17.48.</li> <li id="footer-info-copyright">Wikipedias text är tillgänglig under licensen <a rel="nofollow" class="external text" href="//creativecommons.org/licenses/by-sa/4.0/deed.sv">Creative Commons Erkännande-dela-lika 4.0 Unported</a>. För bilder, se respektive bildsida (klicka på bilden). Se vidare <a href="/wiki/Wikipedia:Upphovsr%C3%A4tt" title="Wikipedia:Upphovsrätt">Wikipedia:Upphovsrätt</a> och <a class="external text" href="https://foundation.wikimedia.org/wiki/Special:MyLanguage/Policy:Terms_of_Use">användarvillkor</a>.</li> </ul> <ul id="footer-places"> <li id="footer-places-privacy"><a href="https://foundation.wikimedia.org/wiki/Special:MyLanguage/Policy:Privacy_policy">Wikimedias integritetspolicy</a></li> <li id="footer-places-about"><a href="/wiki/Wikipedia:Om">Om Wikipedia</a></li> <li id="footer-places-disclaimers"><a href="/wiki/Wikipedia:Allm%C3%A4nt_f%C3%B6rbeh%C3%A5ll">Förbehåll</a></li> <li id="footer-places-wm-codeofconduct"><a href="https://foundation.wikimedia.org/wiki/Special:MyLanguage/Policy:Universal_Code_of_Conduct">Uppförandekod</a></li> <li id="footer-places-developers"><a href="https://developer.wikimedia.org">Utvecklare</a></li> <li id="footer-places-statslink"><a href="https://stats.wikimedia.org/#/sv.wikipedia.org">Statistik</a></li> <li id="footer-places-cookiestatement"><a href="https://foundation.wikimedia.org/wiki/Special:MyLanguage/Policy:Cookie_statement">Information om kakor</a></li> <li id="footer-places-mobileview"><a href="//sv.m.wikipedia.org/w/index.php?title=ISO_13485&section=2&veaction=edit&mobileaction=toggle_view_mobile" class="noprint stopMobileRedirectToggle">Mobilvy</a></li> </ul> <ul id="footer-icons" class="noprint"> <li id="footer-copyrightico"><a href="https://wikimediafoundation.org/" class="cdx-button cdx-button--fake-button cdx-button--size-large cdx-button--fake-button--enabled"><img src="/static/images/footer/wikimedia-button.svg" width="84" height="29" alt="Wikimedia Foundation" loading="lazy"></a></li> <li id="footer-poweredbyico"><a href="https://www.mediawiki.org/" class="cdx-button cdx-button--fake-button cdx-button--size-large cdx-button--fake-button--enabled"><img src="/w/resources/assets/poweredby_mediawiki.svg" alt="Powered by MediaWiki" width="88" height="31" loading="lazy"></a></li> </ul> </footer> </div> </div> </div> <div class="vector-settings" id="p-dock-bottom"> <ul></ul> </div><script>(RLQ=window.RLQ||[]).push(function(){mw.config.set({"wgHostname":"mw-web.codfw.main-f69cdc8f6-828bf","wgBackendResponseTime":239,"wgPageParseReport":{"limitreport":{"cputime":"0.077","walltime":"0.099","ppvisitednodes":{"value":768,"limit":1000000},"postexpandincludesize":{"value":8595,"limit":2097152},"templateargumentsize":{"value":3438,"limit":2097152},"expansiondepth":{"value":14,"limit":100},"expensivefunctioncount":{"value":0,"limit":500},"unstrip-depth":{"value":0,"limit":20},"unstrip-size":{"value":1632,"limit":5000000},"entityaccesscount":{"value":0,"limit":400},"timingprofile":["100.00% 85.185 1 -total"," 59.18% 50.413 1 Mall:Källor"," 53.69% 45.735 1 Mall:Källor_metamall"," 49.72% 42.356 1 Mall:Ambox"," 40.43% 34.444 1 Mall:Webbref"," 32.86% 27.993 1 Mall:Cite_web"," 28.48% 24.259 1 Mall:Citation/core"," 11.83% 10.079 2 Mall:Date"," 2.71% 2.305 1 Mall:Omsubst"," 2.44% 2.077 1 Mall:Link"]},"scribunto":{"limitreport-timeusage":{"value":"0.005","limit":"10.000"},"limitreport-memusage":{"value":663261,"limit":52428800}},"cachereport":{"origin":"mw-web.eqiad.main-6b6c9bdc8b-bndvb","timestamp":"20241104095535","ttl":2592000,"transientcontent":false}}});});</script> <script type="application/ld+json">{"@context":"https:\/\/schema.org","@type":"Article","name":"ISO 13485","url":"https:\/\/sv.wikipedia.org\/wiki\/ISO_13485","sameAs":"http:\/\/www.wikidata.org\/entity\/Q1654689","mainEntity":"http:\/\/www.wikidata.org\/entity\/Q1654689","author":{"@type":"Organization","name":"Bidragsgivare till Wikimedia-projekten"},"publisher":{"@type":"Organization","name":"Wikimedia Foundation, Inc.","logo":{"@type":"ImageObject","url":"https:\/\/www.wikimedia.org\/static\/images\/wmf-hor-googpub.png"}},"datePublished":"2007-08-29T18:03:05Z","dateModified":"2022-05-26T16:48:45Z"}</script> </body> </html>