{"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":"el-cenelec-de-la-ue-publica-la-norma-de-seguridad-iec-60601-2-572026-para-dispositivos-medicos-y-esteticos-no-laser","status":"publish","type":"post","link":"https:\/\/regask.com\/es\/eu-cenelec-publishes-en-iec-60601-2-572026-safety-standard-for-non-laser-medical-and-aesthetic-devices\/","title":{"rendered":"EU CENELEC publica EN IEC 60601-2-57:2026 Normas de seguridad\u2026"},"content":{"rendered":"<p>En<strong> 27 de febrero de 2026, CENELEC<\/strong> public\u00f3 una nueva norma de seguridad europea que cubre <strong>equipo de fuente de luz no l\u00e1ser<\/strong> Se utiliza en aplicaciones m\u00e9dicas y est\u00e9ticas. La norma alinea los requisitos de seguridad y rendimiento con <strong>Reglamento de la UE sobre productos sanitarios (MDR 2017\/745)<\/strong> y se aplica desde <strong>1 de enero de 2026.<\/strong> Afecta a los fabricantes de dispositivos de uso profesional que emiten <strong>ultravioleta (UV), visible o infrarrojo (IR)<\/strong> radiaci\u00f3n de fuentes como LED y l\u00e1mparas, excluidos los l\u00e1seres.<\/p>\n<div class=\"row\"  id=\"row-1982184786\">\n\n\t<div id=\"col-361081380\" 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-75345428\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-75345428 {\n  padding-top: 20px;\n}\n<\/style>\n\t<\/div>\n\t\n<h2>Detalles de la actualizaci\u00f3n<\/h2>\n\t<div id=\"gap-1464170204\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1464170204 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>La norma establece <strong>requisitos esenciales de seguridad y rendimiento<\/strong> para dispositivos de radiaci\u00f3n \u00f3ptica utilizados en procedimientos terap\u00e9uticos, diagn\u00f3sticos, de monitorizaci\u00f3n y est\u00e9ticos. Introduce mejoras <strong>clasificaci\u00f3n de grupos de riesgo, etiquetado de peligro, <\/strong>y<strong> instrucciones del operador<\/strong> para mitigar los riesgos, incluidos <strong>quemaduras en la piel y da\u00f1os en los ojos.\u00a0<\/strong><\/p>\n<p>Los fabricantes deben documentar <strong>clasificaci\u00f3n de grupos de riesgo<\/strong> para todas las fuentes de radiaci\u00f3n \u00f3ptica cubiertas y garantizar<strong> Verificaci\u00f3n de salida de luz uniforme.<\/strong> Los dispositivos de alto riesgo deben transportarse <strong>etiquetado de peligro duradero<\/strong> con informaci\u00f3n de exposici\u00f3n e incluir <strong>instrucciones claras sobre las medidas de protecci\u00f3n<\/strong> para operadores.<\/p>\n<p>El alcance est\u00e1 limitado a <strong>equipo de uso profesional <\/strong>y expl\u00edcitamente<strong> Excluye electrodom\u00e9sticos de uso dom\u00e9stico y camas solares.\u00a0<\/strong><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-361081380 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-863363787\" 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>Alineaci\u00f3n con el MDR de la UE<\/h2>\n\t<div id=\"gap-1653527630\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1653527630 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Los dispositivos que cumplen con el est\u00e1ndar se benefician de <strong>Presunci\u00f3n de conformidad con el MDR de la UE<\/strong> Requisitos a partir de <strong>Enero de 2026.<\/strong> Fabricantes de productos cl\u00ednicos <strong>sistemas de fototerapia, dispositivos de diagn\u00f3stico por im\u00e1genes, equipos de monitorizaci\u00f3n y dispositivos est\u00e9ticos<\/strong> El uso de radiaci\u00f3n \u00f3ptica distinta de l\u00e1ser debe alinear la documentaci\u00f3n t\u00e9cnica y las pr\u00e1cticas de etiquetado para mantener el acceso al mercado de la UE.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-863363787 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1751842645\" 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>Fecha de entrada en vigor<\/h2>\n\t<div id=\"gap-512183109\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-512183109 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>El est\u00e1ndar <strong>EN IEC 60601-2-57:2026 <\/strong>entra en vigor el<strong> 1 de enero de 2026,<\/strong> establecer requisitos formales de cumplimiento para equipos m\u00e9dicos y est\u00e9ticos que no utilicen fuentes de luz l\u00e1ser en la Uni\u00f3n Europea.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1751842645 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-631440226\" 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>Por qu\u00e9 es importante<\/h2>\n\t<div id=\"gap-869318289\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-869318289 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Esta actualizaci\u00f3n <strong>proporciona regulaci\u00f3n<\/strong> Claridad al armonizar las expectativas de seguridad para dispositivos de radiaci\u00f3n \u00f3ptica no l\u00e1ser en el marco del MDR de la UE. Apoya <strong>Alineaci\u00f3n t\u00e9cnica y digital<\/strong> mediante requisitos estandarizados de verificaci\u00f3n y documentaci\u00f3n, mejora <strong>eficiencia operativa,<\/strong> y mantiene una <strong>carga regulatoria neutral<\/strong> para los fabricantes que ya operan bajo obligaciones MDR.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-631440226 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-988591350\" 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>Para qui\u00e9n es relevante<\/h2>\n\t<div id=\"gap-1953979463\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1953979463 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Esta actualizaci\u00f3n es relevante para <strong>Equipos de Asuntos Regulatorios, Garant\u00eda de Calidad, I+D, Ingenier\u00eda y TI<\/strong> Responsable del dise\u00f1o de productos, la gesti\u00f3n de riesgos, la documentaci\u00f3n t\u00e9cnica y el cumplimiento de MDR de dispositivos m\u00e9dicos y est\u00e9ticos basados en radiaci\u00f3n \u00f3ptica.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-988591350 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-367569509\" 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>Pr\u00f3ximos pasos<\/h2>\n\t<div id=\"gap-1763954385\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1763954385 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Los equipos reguladores deber\u00edan <strong>evaluar las carteras de productos actuales frente al nuevo est\u00e1ndar, revisar las pr\u00e1cticas de clasificaci\u00f3n y etiquetado de riesgos,<\/strong> y <strong>coordinar con los equipos de I+D y calidad<\/strong> garantizar que la documentaci\u00f3n t\u00e9cnica y las instrucciones de uso respalden la presunci\u00f3n de conformidad con el MDR.<\/p>\n<p>A medida que las organizaciones se preparan para la aplicaci\u00f3n de esta nueva norma CENELEC, <a href=\"http:\/\/regask.com\/es\/\"><strong>RegASK<\/strong><\/a> Ayuda a los equipos a mantenerse a la vanguardia de los cambiantes requisitos de seguridad de la UE. <a href=\"http:\/\/regask.com\/es\/\"><strong>RegASK<\/strong><\/a> es una plataforma l\u00edder de inteligencia regulatoria y orquestaci\u00f3n de flujo de trabajo con inteligencia artificial (IA) que permite a las organizaciones globales en sectores altamente regulados, incluidos productos de consumo y ciencias biol\u00f3gicas, navegar de manera proactiva en panoramas regulatorios complejos. <strong>Al combinar la IA avanzada de Agentic con expertos en el sector, <a href=\"http:\/\/regask.com\/es\/\">RegASK<\/a><\/strong> Proporciona informaci\u00f3n predictiva y procesable oportuna y automatizaci\u00f3n de extremo a extremo, agilizando los procesos de cumplimiento, mitigando riesgos y acelerando el acceso al mercado en m\u00e1s de 160 pa\u00edses. <a href=\"http:\/\/regask.com\/es\/\"><strong>M\u00e1s informaci\u00f3n <\/strong><\/a>o<a href=\"https:\/\/regask.com\/es\/reservar-una-demostracion\/\"><strong> Reserve una demostraci\u00f3n ahora.\u00a0<\/strong><\/a><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-367569509 > .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-48629380\">\n\n\t<div id=\"col-1819902744\" 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>Preguntas frecuentes<\/h3>\n\t<div id=\"gap-752812911\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-752812911 {\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\">\u00bfCu\u00e1l es la nueva norma CENELEC para equipos m\u00e9dicos con fuente de luz sin l\u00e1ser?<\/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-1658645202\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1658645202 {\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 una norma de seguridad europea publicada el 27 de febrero de 2026 que define los requisitos de seguridad y rendimiento para dispositivos m\u00e9dicos y est\u00e9ticos de uso profesional que emiten radiaci\u00f3n UV, visible o IR desde fuentes distintas del l\u00e1ser.<\/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-1819902744 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-284380768\" 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\">\u00bfCu\u00e1ndo entra en vigor la norma EN IEC 60601-2-57:2026?<\/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-1382328440\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1382328440 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>La norma entra en vigor el <strong>1 de enero de 2026. <\/strong><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-284380768 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1258623002\" 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>\u00bfQu\u00e9 dispositivos entran dentro del \u00e1mbito de aplicaci\u00f3n de esta norma?<\/h4>\n\t<div id=\"gap-1498633626\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1498633626 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Se aplica a<strong> equipos m\u00e9dicos y est\u00e9ticos de uso profesional<\/strong> utilizado en terapia, diagn\u00f3stico, seguimiento y procedimientos cosm\u00e9ticos, excluidos los dispositivos de uso dom\u00e9stico y las camas solares.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1258623002 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-10221805\" 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>\u00bfC\u00f3mo puede RegASK contribuir al cumplimiento de esta norma?<\/h4>\n\t<div id=\"gap-1146921929\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1146921929 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><a href=\"http:\/\/regask.com\/es\/\"><strong>RegASK<\/strong><\/a> permite a los equipos <strong>Realizar un seguimiento de los est\u00e1ndares aplicables, evaluar el impacto de MDR y alinear los flujos de trabajo de documentaci\u00f3n.,<\/strong> Apoyar el cumplimiento eficiente de los nuevos requisitos de seguridad y rendimiento de la UE.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-10221805 > .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":43,"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 v28.4 (Yoast SEO v28.4) - 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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