{"id":9591,"date":"2026-03-04T12:02:18","date_gmt":"2026-03-04T04:02:18","guid":{"rendered":"https:\/\/regask.com\/?p=9591"},"modified":"2026-03-04T12:02:18","modified_gmt":"2026-03-04T04:02:18","slug":"die-eu-cenelec-veroffentlicht-die-sicherheitsnorm-en-iec-60601-2-572026-fur-nicht-laserbasierte-medizinische-und-asthetische-gerate","status":"publish","type":"post","link":"https:\/\/regask.com\/de\/eu-cenelec-publishes-en-iec-60601-2-572026-safety-standard-for-non-laser-medical-and-aesthetic-devices\/","title":{"rendered":"EU CENELEC ver\u00f6ffentlicht Sicherheitsnorm EN IEC 60601-2-57:2026\u2026"},"content":{"rendered":"<p>An<strong> 27. Februar 2026, CENELEC<\/strong> ver\u00f6ffentlichte einen neuen europ\u00e4ischen Sicherheitsstandard, der Folgendes umfasst <strong>nicht-laserbasierte Lichtquellen<\/strong> Wird in medizinischen und \u00e4sthetischen Anwendungen eingesetzt. Der Standard bringt Sicherheits- und Leistungsanforderungen in Einklang mit <strong>EU-Medizinprodukteverordnung (MDR 2017\/745)<\/strong> und gilt ab <strong>1. Januar 2026.<\/strong> Es betrifft Hersteller von Ger\u00e4ten f\u00fcr den professionellen Einsatz, die Emissionen verursachen. <strong>ultraviolett (UV), sichtbar oder infrarot (IR)<\/strong> Strahlung von Quellen wie LEDs und Lampen, ausgenommen Laser.<\/p>\n<div class=\"row\"  id=\"row-1718109369\">\n\n\t<div id=\"col-626776144\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\t<div id=\"gap-401043711\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-401043711 {\n  padding-top: 20px;\n}\n<\/style>\n\t<\/div>\n\t\n<h2>Details zum Update<\/h2>\n\t<div id=\"gap-370878348\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-370878348 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Der Standard legt fest <strong>wesentliche Sicherheits- und Leistungsanforderungen<\/strong> f\u00fcr optische Strahlungsger\u00e4te, die in therapeutischen, diagnostischen, \u00dcberwachungs- und \u00e4sthetischen Verfahren eingesetzt werden. Es f\u00fchrt verbesserte <strong>Risikogruppenklassifizierung, Gefahrenkennzeichnung, <\/strong>Und<strong> Bedienungsanleitung<\/strong> um Risiken zu mindern, einschlie\u00dflich <strong>Hautverbrennungen und Augensch\u00e4den.\u00a0<\/strong><\/p>\n<p>Hersteller m\u00fcssen dokumentieren <strong>Risikogruppenklassifizierung<\/strong> f\u00fcr alle abgedeckten optischen Strahlungsquellen und sicherstellen<strong> \u00dcberpr\u00fcfung der gleichm\u00e4\u00dfigen Lichtausbeute.<\/strong> Hochrisikoger\u00e4te m\u00fcssen mitgef\u00fchrt werden <strong>dauerhafte Gefahrenkennzeichnung<\/strong> mit Expositionsinformationen und einschlie\u00dflich <strong>klare Anweisungen zu Schutzma\u00dfnahmen<\/strong> f\u00fcr Bediener.<\/p>\n<p>Der Umfang ist beschr\u00e4nkt auf <strong>Ausr\u00fcstung f\u00fcr den professionellen Einsatz <\/strong>und ausdr\u00fccklich<strong> Ausgenommen sind Haushaltsger\u00e4te und Sonnenliegen.\u00a0<\/strong><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-626776144 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1238169512\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h2>Angleichung an die EU-MDR<\/h2>\n\t<div id=\"gap-151208242\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-151208242 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Ger\u00e4te, die dem Standard entsprechen, profitieren von <strong>Vermutung der Konformit\u00e4t mit der EU-Medizinprodukteverordnung<\/strong> Anforderungen ab <strong>Januar 2026.<\/strong> Hersteller von klinischen <strong>Phototherapiesysteme, diagnostische Bildgebungsger\u00e4te, \u00dcberwachungsger\u00e4te und \u00e4sthetische Ger\u00e4te<\/strong> Bei der Verwendung von nicht-laserartiger optischer Strahlung m\u00fcssen die technische Dokumentation und die Kennzeichnungspraxis so angepasst werden, dass der Marktzugang in der EU erhalten bleibt.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1238169512 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1297692863\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h2>Datum des Inkrafttretens<\/h2>\n\t<div id=\"gap-992968195\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-992968195 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Der Standard <strong>EN IEC 60601-2-57:2026 <\/strong>tritt in Kraft am<strong> 1. Januar 2026,<\/strong> Festlegung formaler Konformit\u00e4tsanforderungen f\u00fcr medizinische und \u00e4sthetische Ger\u00e4te ohne Laserlichtquelle in der Europ\u00e4ischen Union.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1297692863 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1102111692\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h2>Warum es wichtig ist<\/h2>\n\t<div id=\"gap-1802026796\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1802026796 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Dieses Update <strong>stellt regulatorische<\/strong> Klarheit wird durch die Harmonisierung der Sicherheitsanforderungen f\u00fcr optische Strahlungsger\u00e4te (au\u00dfer Lasern) im Rahmen der EU-Medizinprodukteverordnung (MDR) geschaffen. Sie unterst\u00fctzt <strong>technische und digitale Ausrichtung<\/strong> durch standardisierte Pr\u00fcf- und Dokumentationsanforderungen verbessert <strong>betriebliche Effizienz,<\/strong> und unterh\u00e4lt eine <strong>neutrale regulatorische Belastung<\/strong> f\u00fcr Hersteller, die bereits den MDR-Verpflichtungen unterliegen.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1102111692 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-989553269\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h2>F\u00fcr wen ist das relevant?<\/h2>\n\t<div id=\"gap-1822622765\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1822622765 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Dieses Update ist relevant f\u00fcr <strong>Teams f\u00fcr regulatorische Angelegenheiten, Qualit\u00e4tssicherung, Forschung und Entwicklung, Engineering und IT<\/strong> verantwortlich f\u00fcr Produktdesign, Risikomanagement, technische Dokumentation und MDR-Konformit\u00e4t von auf optischer Strahlung basierenden medizinischen und \u00e4sthetischen Ger\u00e4ten.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-989553269 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-445802556\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h2>N\u00e4chste Schritte<\/h2>\n\t<div id=\"gap-1067470360\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1067470360 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Die Regulierungsbeh\u00f6rden sollten <strong>die aktuellen Produktportfolios anhand des neuen Standards bewerten, die Risikoklassifizierung und die Kennzeichnungspraxis \u00fcberpr\u00fcfen,<\/strong> Und <strong>Abstimmung mit den Forschungs- und Entwicklungs- sowie den Qualit\u00e4tsteams<\/strong> um sicherzustellen, dass die technische Dokumentation und die Gebrauchsanweisung die Konformit\u00e4tsvermutung der MDR unterst\u00fctzen.<\/p>\n<p>W\u00e4hrend sich Organisationen auf die Anwendung dieses neuen CENELEC-Standards vorbereiten, <a href=\"http:\/\/regask.com\/de\/\"><strong>RegASK<\/strong><\/a> Hilft Teams dabei, den sich st\u00e4ndig weiterentwickelnden EU-Sicherheitsanforderungen immer einen Schritt voraus zu sein. <a href=\"http:\/\/regask.com\/de\/\"><strong>RegASK<\/strong><\/a> ist eine f\u00fchrende agentenbasierte KI-Plattform f\u00fcr regulatorische Intelligenz und Workflow-Orchestrierung, die globale Organisationen in stark regulierten Sektoren, darunter Konsumg\u00fcter und Biowissenschaften, in die Lage versetzt, proaktiv durch komplexe regulatorische Landschaften zu navigieren. <strong>Durch die Kombination von fortschrittlicher Agentic-KI mit Expertenwissen, <a href=\"http:\/\/regask.com\/de\/\">RegASK<\/a><\/strong> liefert zeitnahe, vorausschauende und umsetzbare Erkenntnisse sowie eine durchg\u00e4ngige Automatisierung, optimiert Compliance-Prozesse, mindert Risiken und beschleunigt den Marktzugang in mehr als 160 L\u00e4ndern. <a href=\"http:\/\/regask.com\/de\/\"><strong>Mehr erfahren <\/strong><\/a>oder<a href=\"https:\/\/regask.com\/de\/demo-buchen\/\"><strong> Jetzt Demo buchen.\u00a0<\/strong><\/a><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-445802556 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n<\/div>\n<div class=\"row\"  id=\"row-1345644742\">\n\n\t<div id=\"col-1890925938\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<div class=\"is-divider divider clearfix\" style=\"margin-top:2em;margin-bottom:2em;max-width:20%;height:1px;background-color:#a5acd9;\"><\/div>\n<h3>FAQs<\/h3>\n\t<div id=\"gap-1280552346\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1280552346 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<h4><span class=\"TextRun MacChromeBold SCXW131954740 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW131954740 BCX0\">Was ist der neue CENELEC-Standard f\u00fcr medizinische Ger\u00e4te ohne Laserlichtquelle?<\/span><\/span><span class=\"EOP SCXW131954740 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/h4>\n\t<div id=\"gap-879977739\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-879977739 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW74405843 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW74405843 BCX0\">Es handelt sich um eine europ\u00e4ische Sicherheitsnorm, die am 27. Februar 2026 ver\u00f6ffentlicht wurde und Sicherheits- und Leistungsanforderungen f\u00fcr medizinische und \u00e4sthetische Ger\u00e4te f\u00fcr den professionellen Gebrauch definiert, die UV-, sichtbare oder IR-Strahlung aus nicht-laserbasierten Quellen abgeben.<\/span><\/span><span class=\"EOP SCXW74405843 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1890925938 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-55256373\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h4><span class=\"TextRun MacChromeBold SCXW254600192 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW254600192 BCX0\">Wann tritt EN IEC 60601-2-57:2026 in Kraft?<\/span><\/span><span class=\"EOP SCXW254600192 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/h4>\n\t<div id=\"gap-859699039\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-859699039 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Die Norm tritt in Kraft am <strong>1. Januar 2026. <\/strong><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-55256373 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-616919575\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h4>Welche Ger\u00e4te fallen unter den Geltungsbereich dieser Norm?<\/h4>\n\t<div id=\"gap-1394839755\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1394839755 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Es gilt f\u00fcr<strong> Medizinische und \u00e4sthetische Ger\u00e4te f\u00fcr den professionellen Einsatz<\/strong> Anwendung in Therapie, Diagnostik, \u00dcberwachung und kosmetischen Eingriffen, ausgenommen Ger\u00e4te f\u00fcr den Heimgebrauch und Solarien.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-616919575 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1254139090\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h4>Wie kann RegASK die Einhaltung dieses Standards unterst\u00fctzen?<\/h4>\n\t<div id=\"gap-1145817771\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1145817771 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><a href=\"http:\/\/regask.com\/de\/\"><strong>RegASK<\/strong><\/a> erm\u00f6glicht es Teams <strong>Anwendbare Standards verfolgen, Auswirkungen der MDR bewerten und Dokumentationsabl\u00e4ufe aufeinander abstimmen,<\/strong> Unterst\u00fctzung der effizienten Einhaltung neuer EU-Sicherheits- und Leistungsanforderungen.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1254139090 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n<\/div>","protected":false},"excerpt":{"rendered":"<p>On 27 February 2026, CENELEC published a new European safety standard covering non-laser light source equipment used in medical and aesthetic applications. The standard aligns safety and performance requirements with EU Medical Device Regulation (MDR 2017\/745) and applies from 1 January 2026. It affects manufacturers of professional-use devices emitting ultraviolet (UV), visible, or infrared (IR)&#8230;<\/p>","protected":false},"author":41,"featured_media":9592,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[33,538,39],"tags":[],"class_list":["post-9591","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news","category-european-union","category-medical-devices-insights"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.3 (Yoast SEO v27.3) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>EU CENELEC Publishes EN IEC 60601-2-57:2026 Overview<\/title>\n<meta name=\"description\" content=\"CENELEC&#039;s new safety standard for non-laser medical devices sets essential performance and safety requirements effective January 2026.\" \/>\n<meta name=\"robots\" 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