{"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":"lorganisme-europeen-cenelec-publie-la-norme-de-securite-en-iec-60601-2572026-relative-aux-dispositifs-medicaux-et-esthetiques-non-laser","status":"publish","type":"post","link":"https:\/\/regask.com\/fr\/eu-cenelec-publishes-en-iec-60601-2-572026-safety-standard-for-non-laser-medical-and-aesthetic-devices\/","title":{"rendered":"L&#039;UE CENELEC publie la norme de s\u00e9curit\u00e9 EN IEC 60601-2-57:2026\u2026"},"content":{"rendered":"<p>Sur<strong> 27 f\u00e9vrier 2026, CENELEC<\/strong> a publi\u00e9 une nouvelle norme de s\u00e9curit\u00e9 europ\u00e9enne couvrant <strong>\u00e9quipement de source de lumi\u00e8re non laser<\/strong> Utilis\u00e9e dans les applications m\u00e9dicales et esth\u00e9tiques, cette norme aligne les exigences de s\u00e9curit\u00e9 et de performance sur celles-ci. <strong>R\u00e8glement europ\u00e9en relatif aux dispositifs m\u00e9dicaux (RDM 2017\/745)<\/strong> et s&#039;applique \u00e0 partir de <strong>1er janvier 2026.<\/strong> Cela affecte les fabricants d&#039;appareils \u00e0 usage professionnel \u00e9mettant <strong>ultraviolet (UV), visible ou infrarouge (IR)<\/strong> Rayonnement provenant de sources telles que les LED et les lampes, \u00e0 l&#039;exclusion des lasers.<\/p>\n<div class=\"row\"  id=\"row-249684505\">\n\n\t<div id=\"col-1417975460\" 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-291477143\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-291477143 {\n  padding-top: 20px;\n}\n<\/style>\n\t<\/div>\n\t\n<h2>D\u00e9tails de la mise \u00e0 jour<\/h2>\n\t<div id=\"gap-7999916\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-7999916 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>La norme \u00e9tablit <strong>exigences essentielles en mati\u00e8re de s\u00e9curit\u00e9 et de performance<\/strong> pour les dispositifs \u00e0 rayonnement optique utilis\u00e9s dans les proc\u00e9dures th\u00e9rapeutiques, diagnostiques, de surveillance et esth\u00e9tiques. Il introduit des am\u00e9liorations <strong>classification des groupes \u00e0 risque, \u00e9tiquetage des dangers, <\/strong>et<strong> instructions de l&#039;op\u00e9rateur<\/strong> pour att\u00e9nuer les risques, notamment <strong>Br\u00fblures cutan\u00e9es et l\u00e9sions oculaires.\u00a0<\/strong><\/p>\n<p>Les fabricants doivent documenter <strong>classification des groupes \u00e0 risque<\/strong> pour toutes les sources de rayonnement optique couvertes et assurer<strong> V\u00e9rification de l&#039;uniformit\u00e9 du flux lumineux.<\/strong> Les dispositifs \u00e0 haut risque doivent \u00eatre transport\u00e9s <strong>\u00e9tiquetage de danger durable<\/strong> avec des informations sur l&#039;exposition et incluent <strong>des instructions claires sur les mesures de protection<\/strong> pour les op\u00e9rateurs.<\/p>\n<p>La port\u00e9e se limite \u00e0 <strong>\u00e9quipement \u00e0 usage professionnel <\/strong>et explicitement<strong> Sont exclus les appareils \u00e9lectrom\u00e9nagers et les lits de bronzage.\u00a0<\/strong><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1417975460 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-224991415\" 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>Conformit\u00e9 avec le r\u00e8glement europ\u00e9en relatif aux dispositifs m\u00e9dicaux (MDR)<\/h2>\n\t<div id=\"gap-201972225\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-201972225 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Les appareils conformes \u00e0 la norme b\u00e9n\u00e9ficient de <strong>pr\u00e9somption de conformit\u00e9 au r\u00e8glement europ\u00e9en sur les dispositifs m\u00e9dicaux (MDR)<\/strong> exigences commen\u00e7ant par <strong>Janvier 2026.<\/strong> Fabricants de produits cliniques <strong>syst\u00e8mes de phototh\u00e9rapie, appareils d&#039;imagerie diagnostique, \u00e9quipements de surveillance et appareils esth\u00e9tiques<\/strong> L\u2019utilisation de rayonnements optiques non laser doit harmoniser la documentation technique et les pratiques d\u2019\u00e9tiquetage afin de maintenir l\u2019acc\u00e8s au march\u00e9 de l\u2019UE.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-224991415 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1183099002\" 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>Date d&#039;entr\u00e9e en vigueur<\/h2>\n\t<div id=\"gap-1992763005\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1992763005 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>La norme <strong>EN IEC 60601-2-57:2026 <\/strong>entre en vigueur le<strong> 1er janvier 2026,<\/strong> \u00c9tablir des exigences de conformit\u00e9 formelles pour les \u00e9quipements m\u00e9dicaux et esth\u00e9tiques \u00e0 source de lumi\u00e8re non laser dans l&#039;Union europ\u00e9enne.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1183099002 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-2075489455\" 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>Pourquoi c&#039;est important<\/h2>\n\t<div id=\"gap-1990368957\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1990368957 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Cette mise \u00e0 jour <strong>fournit une r\u00e9glementation<\/strong> Il apporte de la clart\u00e9 en harmonisant les exigences de s\u00e9curit\u00e9 relatives aux dispositifs \u00e0 rayonnement optique non laser dans le cadre du r\u00e8glement europ\u00e9en relatif aux dispositifs m\u00e9dicaux (MDR). <strong>alignement technique et num\u00e9rique<\/strong> gr\u00e2ce \u00e0 des exigences normalis\u00e9es en mati\u00e8re de v\u00e9rification et de documentation, am\u00e9liore <strong>efficacit\u00e9 op\u00e9rationnelle,<\/strong> et maintient un <strong>charge r\u00e9glementaire neutre<\/strong> pour les fabricants d\u00e9j\u00e0 soumis aux obligations du r\u00e8glement relatif aux dispositifs m\u00e9dicaux (MDR).<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-2075489455 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-63944649\" 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>\u00c0 qui cela s&#039;adresse-t-il ?<\/h2>\n\t<div id=\"gap-1812149996\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1812149996 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Cette mise \u00e0 jour est pertinente pour <strong>\u00c9quipes des affaires r\u00e9glementaires, de l&#039;assurance qualit\u00e9, de la recherche et du d\u00e9veloppement, de l&#039;ing\u00e9nierie et des technologies de l&#039;information<\/strong> responsable de la conception des produits, de la gestion des risques, de la documentation technique et de la conformit\u00e9 au r\u00e8glement MDR des dispositifs m\u00e9dicaux et esth\u00e9tiques \u00e0 rayonnement optique.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-63944649 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1468669928\" 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>Prochaines \u00e9tapes<\/h2>\n\t<div id=\"gap-389800271\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-389800271 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Les \u00e9quipes r\u00e9glementaires devraient <strong>\u00e9valuer les portefeuilles de produits actuels par rapport \u00e0 la nouvelle norme, revoir les pratiques de classification des risques et d&#039;\u00e9tiquetage,<\/strong> et <strong>se coordonner avec les \u00e9quipes R&amp;D et qualit\u00e9<\/strong> afin de garantir que la documentation technique et les instructions d&#039;utilisation soutiennent la pr\u00e9somption de conformit\u00e9 du r\u00e8glement MDR.<\/p>\n<p>Alors que les organisations se pr\u00e9parent \u00e0 l&#039;application de cette nouvelle norme CENELEC, <a href=\"http:\/\/regask.com\/fr\/\"><strong>RegASK<\/strong><\/a> aide les \u00e9quipes \u00e0 anticiper l&#039;\u00e9volution des exigences de s\u00e9curit\u00e9 de l&#039;UE. <a href=\"http:\/\/regask.com\/fr\/\"><strong>RegASK<\/strong><\/a> est une plateforme de pointe d&#039;intelligence r\u00e9glementaire et d&#039;orchestration des flux de travail bas\u00e9e sur l&#039;IA agentielle, qui permet aux organisations mondiales des secteurs hautement r\u00e9glement\u00e9s, notamment les produits de consommation et les sciences de la vie, de naviguer de mani\u00e8re proactive dans des environnements r\u00e9glementaires complexes. <strong>En combinant une IA agentique avanc\u00e9e avec des experts impliqu\u00e9s, <a href=\"http:\/\/regask.com\/fr\/\">RegASK<\/a><\/strong> Elle fournit en temps opportun des informations pr\u00e9dictives exploitables et une automatisation de bout en bout, rationalisant les processus de conformit\u00e9, att\u00e9nuant les risques et acc\u00e9l\u00e9rant l&#039;acc\u00e8s au march\u00e9 dans plus de 160 pays. <a href=\"http:\/\/regask.com\/fr\/\"><strong>En savoir plus <\/strong><\/a>ou<a href=\"https:\/\/regask.com\/fr\/reserver-une-demo\/\"><strong> r\u00e9servez une d\u00e9mo maintenant.\u00a0<\/strong><\/a><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1468669928 > .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-214693585\">\n\n\t<div id=\"col-240608414\" 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>FAQ<\/h3>\n\t<div id=\"gap-4929298\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-4929298 {\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\">Quelle est la nouvelle norme CENELEC pour les \u00e9quipements m\u00e9dicaux \u00e0 source lumineuse non laser\u00a0?<\/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-2129071393\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-2129071393 {\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\">Il s&#039;agit d&#039;une norme de s\u00e9curit\u00e9 europ\u00e9enne publi\u00e9e le 27 f\u00e9vrier 2026 qui d\u00e9finit les exigences de s\u00e9curit\u00e9 et de performance des dispositifs m\u00e9dicaux et esth\u00e9tiques \u00e0 usage professionnel \u00e9mettant des rayonnements UV, visibles ou IR \u00e0 partir de sources non laser.<\/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-240608414 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-358107208\" 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\">Quand la norme EN IEC 60601-2-57:2026 entre-t-elle en vigueur\u00a0?<\/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-259455866\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-259455866 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>La norme entre en vigueur le <strong>1er janvier 2026. <\/strong><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-358107208 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1017247421\" 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>Quels appareils rel\u00e8vent du champ d&#039;application de cette norme\u00a0?<\/h4>\n\t<div id=\"gap-1979057877\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1979057877 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Cela s&#039;applique \u00e0<strong> \u00e9quipement m\u00e9dical et esth\u00e9tique \u00e0 usage professionnel<\/strong> Utilis\u00e9 en th\u00e9rapie, en diagnostic, en surveillance et en proc\u00e9dures cosm\u00e9tiques, \u00e0 l&#039;exclusion des appareils \u00e0 usage domestique et des lits de bronzage.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1017247421 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1383228454\" 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>Comment la norme RegASK peut-elle garantir la conformit\u00e9 \u00e0 cette norme\u00a0?<\/h4>\n\t<div id=\"gap-546030660\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-546030660 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><a href=\"http:\/\/regask.com\/fr\/\"><strong>RegASK<\/strong><\/a> permet aux \u00e9quipes de <strong>Suivre les normes applicables, \u00e9valuer l&#039;impact du MDR et harmoniser les flux de travail de documentation.,<\/strong> favoriser une conformit\u00e9 efficace aux nouvelles exigences de l&#039;UE en mati\u00e8re de s\u00e9curit\u00e9 et de performance.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1383228454 > .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":[33,39,538],"tags":[],"class_list":["post-9591","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news","category-medical-devices-insights","category-european-union"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.3 (Yoast SEO v27.5) - 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\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/regask.com\/fr\/lorganisme-europeen-cenelec-publie-la-norme-de-securite-en-iec-60601-2572026-relative-aux-dispositifs-medicaux-et-esthetiques-non-laser\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"EU CENELEC Publishes EN IEC 60601-2-57:2026 Safety Standard for Non-Laser Medical and Aesthetic Devices\" \/>\n<meta property=\"og:description\" content=\"CENELEC&#039;s new safety standard for non-laser medical devices sets essential performance and safety requirements effective January 2026.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/regask.com\/fr\/lorganisme-europeen-cenelec-publie-la-norme-de-securite-en-iec-60601-2572026-relative-aux-dispositifs-medicaux-et-esthetiques-non-laser\/\" \/>\n<meta property=\"og:site_name\" content=\"RegASK\" 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\/>\n\t<meta name=\"twitter:data2\" content=\"4 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/regask.com\\\/eu-cenelec-publishes-en-iec-60601-2-572026-safety-standard-for-non-laser-medical-and-aesthetic-devices\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/regask.com\\\/eu-cenelec-publishes-en-iec-60601-2-572026-safety-standard-for-non-laser-medical-and-aesthetic-devices\\\/\"},\"author\":{\"name\":\"Shaffa Renaningtyas\",\"@id\":\"https:\\\/\\\/regask.com\\\/#\\\/schema\\\/person\\\/b0e1938ef6f244f9f052a21f21cba1b6\"},\"headline\":\"EU CENELEC Publishes EN IEC 60601-2-57:2026 Safety 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