{"id":8412,"date":"2025-11-20T23:14:59","date_gmt":"2025-11-20T23:14:59","guid":{"rendered":"https:\/\/kmslaser.com\/?p=8412"},"modified":"2025-11-20T23:14:59","modified_gmt":"2025-11-20T23:14:59","slug":"la-machine-de-therapie-par-ondes-de-choc-necessite-t-elle-une-certification-ul","status":"publish","type":"post","link":"https:\/\/kmslaser.com\/fr\/does-the-shockwave-therapy-machine-require-ul-certification\/","title":{"rendered":"La machine de th\u00e9rapie par ondes de choc n\u00e9cessite-t-elle une certification UL ?"},"content":{"rendered":"<p style=\"float: right; margin-left: 15px; margin-bottom: 15px;\">\n  <img decoding=\"async\" src=\"https:\/\/kmslaser.com\/wp-content\/uploads\/2025\/11\/1a-technical-infographic-style-rendering-showing-th.jpg\" alt=\"Infographie du parcours r\u00e9glementaire pour les \u00e9tapes de conformit\u00e9 des dispositifs m\u00e9dicaux (ID#1)\" class=\"top-image-square\">\n<\/p>\n<p>En tant que fabricant, je re\u00e7ois cette question lors de presque tous les appels d'approvisionnement aux \u00c9tats-Unis, je vais donc exposer la r\u00e9alit\u00e9 pratique et r\u00e9glementaire en langage clair. <sup><a href=\"#footnote-1\" id=\"ref-1\">1<\/a><\/sup><\/p>\n<p><strong>La certification UL elle-m\u00eame n'est pas une exigence statutaire de la FDA, mais une liste reconnue par un NRTL selon la norme IEC\/UL 60601-1 (et 60601-1-2 pour la CEM) est effectivement obligatoire pour l'acceptation dans les h\u00f4pitaux am\u00e9ricains, les inspections \u00e9lectriques, l'int\u00e9gration par les assureurs et de nombreux contrats de distributeurs.<\/strong><\/p>\n<p>Voici comment nous naviguons entre UL et CE, quels documents vous devriez exiger, et quand une marque UL est obligatoire par rapport \u00e0 fortement recommand\u00e9e.<\/p>\n<hr \/>\n<h2>Quelles certifications de s\u00e9curit\u00e9 sont essentielles pour entrer sur le march\u00e9 am\u00e9ricain ?<\/h2>\n<p>En tant que fabricant, je con\u00e7ois pour les \u00c9tats-Unis d\u00e8s le premier jour : s\u00e9curit\u00e9 IEC\/UL 60601-1, CEM 60601-1-2, et une liste NRTL (UL, ETL\/Intertek, T\u00dcV, CSA). Cette combinaison permet de faire avancer les appels d'offres et d'\u00e9viter que les appareils ne tombent dans le purgatoire douanier. <sup><a href=\"#footnote-2\" id=\"ref-2\">2<\/a><\/sup><\/p>\n<p><strong>Pour entrer sur le march\u00e9 am\u00e9ricain de la sant\u00e9, vous avez besoin de : (1) un parcours r\u00e9glementaire FDA pour les dispositifs (par exemple, 510(k) si applicable), (2) s\u00e9curit\u00e9 \u00e9lectrique + CEM selon IEC\/UL 60601-1\/-1-2, et (3) une liste et une \u00e9tiquette d'un Laboratoire d'Essais Reconnus au Niveau National (NRTL). De nombreux h\u00f4pitaux exigent explicitement une marque UL ou NRTL \u00e9quivalente sur la plaque signal\u00e9tique.<\/strong><\/p>\n<p><img decoding=\"async\" src=\"https:\/\/kmslaser.com\/wp-content\/uploads\/2025\/11\/2a-detailed-illustration-of-a-proper-u-s-compliant.jpg\" alt=\"Plaque d&#039;\u00e9quipement \u00e9tiquet\u00e9e UL montrant les certifications de s\u00e9curit\u00e9 (ID#2)\" title=\"\u00c9tiquetage de s\u00e9curit\u00e9 UL\" \/><\/p>\n<h3>Ce qu'un acheteur devrait voir sur un appareil conforme<\/h3>\n<ul>\n<li>Marque de liste NRTL (UL, ETL, T\u00dcV, CSA)  <\/li>\n<li>IEC\/UL 60601-1 \u00c9d. 3.x, et IEC 60601-1-2 \u00c9d. 4.x  <\/li>\n<li>Marquage pour usage professionnel en milieu de sant\u00e9 \/ usage \u00e0 domicile  <\/li>\n<li>Documentation FDA 510(k) ou exemption  <\/li>\n<li>Certification ISO 13485  <\/li>\n<\/ul>\n<h3>Tableau 1 \u2014 Essentiels pour l'entr\u00e9e sur le march\u00e9 am\u00e9ricain (en un coup d'\u0153il)<\/h3>\n<table>\n<thead>\n<tr>\n<th>Cat\u00e9gorie<\/th>\n<th>Attente minimale<\/th>\n<th>Pourquoi c'est important<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>S\u00e9curit\u00e9 \u00e9lectrique<\/td>\n<td>CEI\/UL 60601-1 (\u00c9d. 3.x)<\/td>\n<td>Protection du patient\/op\u00e9rateur<\/td>\n<\/tr>\n<tr>\n<td>CEM<\/td>\n<td>CEI 60601-1-2 (\u00c9d. 4.x)<\/td>\n<td>Immunit\u00e9 et \u00e9missions<\/td>\n<\/tr>\n<tr>\n<td>Liste NRTL<\/td>\n<td>UL \/ ETL \/ T\u00dcV \/ CSA<\/td>\n<td>Requis par les inspecteurs et les h\u00f4pitaux<\/td>\n<\/tr>\n<tr>\n<td>Voie FDA<\/td>\n<td>510(k)\/De Novo\/exemption<\/td>\n<td>Autorisation l\u00e9gale<\/td>\n<\/tr>\n<tr>\n<td>SMQ<\/td>\n<td>ISO 13485<\/td>\n<td>Qualit\u00e9 de fabrication<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<hr \/>\n<h2>Comment UL se compare-t-il \u00e0 CE ou \u00e0 d'autres normes de s\u00e9curit\u00e9 internationales ?<\/h2>\n<p>En tant que fabricant, je consid\u00e8re UL comme une passerelle nord-am\u00e9ricaine et CE comme le passeport europ\u00e9en. Les deux remontent \u00e0 la CEI 60601, mais chacun a des r\u00e8gles, des audits et des attentes locales. <sup><a href=\"#footnote-3\" id=\"ref-3\">3<\/a><\/sup><\/p>\n<p><strong>UL (ou autre NRTL) est la voie de conformit\u00e9 U.S.\/Canada\u2026 Le marquage CE d\u00e9montre la conformit\u00e9 au MDR de l'UE\u2026 Le syst\u00e8me CB de l'IECEE peut relier les donn\u00e9es de test\u2026<\/strong><\/p>\n<p><img decoding=\"async\" src=\"https:\/\/kmslaser.com\/wp-content\/uploads\/2025\/11\/3a-side-by-side-comparison-graphic-showing-ul-nrtl-.jpg\" alt=\"Graphique comparatif de la conformit\u00e9 UL-NRTL et CE\/MDR (ID#3)\" title=\"Comparaison de la conformit\u00e9\" \/><\/p>\n<h3>Tableau 2 \u2014 UL vs. CE vs. Syst\u00e8me CB<\/h3>\n<table>\n<thead>\n<tr>\n<th>Aspect<\/th>\n<th>UL\/NRTL<\/th>\n<th>CE<\/th>\n<th>Syst\u00e8me CB<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>Base l\u00e9gale<\/td>\n<td>OSHA\/NRTL, NFPA 99<\/td>\n<td>MDR de l'UE<\/td>\n<td>Reconnaissance mutuelle IEC<\/td>\n<\/tr>\n<tr>\n<td>Normes<\/td>\n<td>IEC 60601 + d\u00e9viations US\/CA<\/td>\n<td>EN 60601<\/td>\n<td>IEC 60601<\/td>\n<\/tr>\n<tr>\n<td>Marque<\/td>\n<td>UL\/ETL\/T\u00dcV\/CSA<\/td>\n<td>CE<\/td>\n<td>Pas de marque<\/td>\n<\/tr>\n<tr>\n<td>Utiliser<\/td>\n<td>H\u00f4pitaux, inspecteurs AHJ<\/td>\n<td>Appels d'offres de l'UE<\/td>\n<td>Passeport de donn\u00e9es<\/td>\n<\/tr>\n<tr>\n<td>Qui l'exige<\/td>\n<td>Assureurs, h\u00f4pitaux<\/td>\n<td>R\u00e9gulateurs de l'UE<\/td>\n<td>Organismes de certification<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p><strong>En r\u00e9sum\u00e9 :<\/strong> CE \u2260 UL. Un appareil CE n\u00e9cessite toujours une homologation NRTL am\u00e9ricaine pour \u00eatre accept\u00e9 par les h\u00f4pitaux. <sup><a href=\"#footnote-4\" id=\"ref-4\">4<\/a><\/sup><\/p>\n<hr \/>\n<h2>Quelle documentation les fournisseurs doivent-ils fournir pour confirmer la conformit\u00e9 UL ?<\/h2>\n<p>En tant que fabricant, j'accueille favorablement les demandes de documentation rigoureuses \u2014 elles distinguent les v\u00e9ritables \u00e9quipementiers des revendeurs. <sup><a href=\"#footnote-5\" id=\"ref-5\">5<\/a><\/sup><\/p>\n<p><strong>Demandez un certificat d'homologation NRTL, un certificat d'essai CB, les rapports d'essai complets 60601-1\/-1-2 et des photos de la plaque signal\u00e9tique officielle portant le label NRTL.<\/strong><\/p>\n<p><img decoding=\"async\" src=\"https:\/\/kmslaser.com\/wp-content\/uploads\/2025\/11\/4a-hospital-procurement-office-scene-with-a-complia.jpg\" alt=\"Ing\u00e9nieur examinant les documents de certification NRTL et CEM au bureau (ID#4)\" title=\"Examen de la certification\" \/><\/p>\n<h3>Tableau 3 \u2014 Liste de v\u00e9rification de la validation UL\/NRTL<\/h3>\n<table>\n<thead>\n<tr>\n<th>Document<\/th>\n<th>Quoi v\u00e9rifier<\/th>\n<th>Signaux d'alerte<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>Certificat NRTL<\/td>\n<td>Mod\u00e8le, site, normes<\/td>\n<td>Mod\u00e8le diff\u00e9rent<\/td>\n<\/tr>\n<tr>\n<td>Plaque signal\u00e9tique<\/td>\n<td>Marque, num\u00e9ro de dossier<\/td>\n<td>\u0152uvre d'art falsifi\u00e9e<\/td>\n<\/tr>\n<tr>\n<td>Rapport 60601-1<\/td>\n<td>D\u00e9viations appliqu\u00e9es<\/td>\n<td>Sections manquantes<\/td>\n<\/tr>\n<tr>\n<td>Rapport CEM<\/td>\n<td>Configuration + environnement<\/td>\n<td>Accessoires incorrects<\/td>\n<\/tr>\n<tr>\n<td>Certificat CB<\/td>\n<td>La construction correspond<\/td>\n<td>Options manquantes<\/td>\n<\/tr>\n<tr>\n<td>Contr\u00f4le des modifications<\/td>\n<td>Journaux firmware\/mat\u00e9riel<\/td>\n<td>Changements non r\u00e9pertori\u00e9s<\/td>\n<\/tr>\n<tr>\n<td>ISO 13485<\/td>\n<td>Bon site et p\u00e9rim\u00e8tre<\/td>\n<td>Expir\u00e9<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<hr \/>\n<h2>La certification UL est-elle obligatoire ou recommand\u00e9e en fonction de l'application ?<\/h2>\n<p>En tant que fabricant, je segmente par environnement. En pratique, les h\u00f4pitaux exigent une marque NRTL ; les med-spas peuvent accepter des alternatives. <sup><a href=\"#footnote-6\" id=\"ref-6\">6<\/a><\/sup><\/p>\n<p><strong>L\u00e9galement, UL n'est pas \u201cla seule voie\u201d, mais une liste NRTL est de facto obligatoire dans les h\u00f4pitaux et fortement recommand\u00e9e partout ailleurs.<\/strong><\/p>\n<p><img decoding=\"async\" src=\"https:\/\/kmslaser.com\/wp-content\/uploads\/2025\/11\/5a-premium-infographic-showing-five-application-are.jpg\" alt=\"Infographie de l&#039;application (ID#5)\" title=\"Aper\u00e7u de l&#039;application\" \/><\/p>\n<h3>Tableau 4 \u2014 Quand UL\/NRTL est requis vs. facultatif<\/h3>\n<table>\n<thead>\n<tr>\n<th>Application<\/th>\n<th>Attente<\/th>\n<th>Pourquoi<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>H\u00f4pitaux<\/td>\n<td><strong>Obligatoire<\/strong><\/td>\n<td>NFPA 99, assureurs, AHJ<\/td>\n<\/tr>\n<tr>\n<td>Cha\u00eenes de cliniques<\/td>\n<td><strong>Obligatoire<\/strong><\/td>\n<td>Conformit\u00e9 SOP<\/td>\n<\/tr>\n<tr>\n<td>Med-spa<\/td>\n<td>Fortement recommand\u00e9<\/td>\n<td>Responsabilit\u00e9<\/td>\n<\/tr>\n<tr>\n<td>Usage domestique<\/td>\n<td>Recommand\u00e9<\/td>\n<td>Les tests d'immunit\u00e9 diff\u00e8rent<\/td>\n<\/tr>\n<tr>\n<td>Laboratoires de recherche<\/td>\n<td>Au cas par cas<\/td>\n<td>Examen EHS<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>La mise \u00e0 l'\u00e9chelle aux \u00c9tats-Unis est plus facile lorsque UL\/ETL\/T\u00dcV est inclus d\u00e8s le d\u00e9but. La certification r\u00e9troactive est co\u00fbteuse. <sup><a href=\"#footnote-7\" id=\"ref-7\">7<\/a><\/sup><\/p>\n<hr \/>\n<h2>Conclusion<\/h2>\n<p>En tant que fabricant, mon conseil est simple : construisez selon la norme IEC 60601-1\/-1-2, planifiez une homologation NRTL d\u00e8s le d\u00e9but et maintenez les certificats et la construction enti\u00e8rement align\u00e9s. Cela \u00e9vite les \u00e9checs d'inspection et garantit l'acceptation des appareils dans les h\u00f4pitaux et chez les distributeurs. <sup><a href=\"#footnote-8\" id=\"ref-8\">8<\/a><\/sup><\/p>\n<hr \/>\n<h1>Notes de bas de page (Total : <strong>10<\/strong>)<\/h1>\n<p><span id=\"footnote-1\">1. L'OSHA explique ce qu'est la certification NRTL et pourquoi elle est requise pour les \u00e9quipements \u00e9lectriques. <a href=\"#ref-1\">\ufe0e<\/a> \u2014 <a href=\"https:\/\/www.osha.gov\/nationally-recognized-testing-laboratory-program\">https:\/\/www.osha.gov\/nationally-recognized-testing-laboratory-program<\/a><\/span><br \/>\n<span id=\"footnote-2\">2. Guide de la FDA sur les attentes en mati\u00e8re de s\u00e9curit\u00e9 \u00e9lectrique des dispositifs m\u00e9dicaux. <a href=\"#ref-2\">\ufe0e<\/a> \u2014 <a href=\"https:\/\/www.fda.gov\/medical-devices\">https:\/\/www.fda.gov\/medical-devices<\/a><\/span><br \/>\n<span id=\"footnote-3\">3. Pr\u00e9sentation de l'IECEE sur le sch\u00e9ma CB 60601 pour les dispositifs m\u00e9dicaux \u00e9lectriques. <a href=\"#ref-3\">\ufe0e<\/a> \u2014 <a href=\"https:\/\/www.iecee.org\">https:\/\/www.iecee.org<\/a><\/span><br \/>\n<span id=\"footnote-4\">4. R\u00e9sum\u00e9 de UL sur les diff\u00e9rences entre la conformit\u00e9 UL\/NRTL et CE\/IEC. <a href=\"#ref-4\">\ufe0e<\/a> \u2014 <a href=\"https:\/\/www.ul.com\">https:\/\/www.ul.com<\/a><\/span><br \/>\n<span id=\"footnote-5\">5. Explication par Intertek de la norme 60601-1 et de la documentation d'homologation NRTL. <a href=\"#ref-5\">\ufe0e<\/a> \u2014 <a href=\"https:\/\/www.intertek.com\/medical\/iec-60601\/\">https:\/\/www.intertek.com\/medical\/iec-60601\/<\/a><\/span><br \/>\n<span id=\"footnote-6\">6. Pr\u00e9sentation de T\u00dcV S\u00dcD sur l'importance de la NRTL pour l'acc\u00e8s au march\u00e9 am\u00e9ricain. <a href=\"#ref-6\">\ufe0e<\/a> \u2014 <a href=\"https:\/\/www.tuvsud.com\/en-us\/services\/product-certification\/nrtl\">https:\/\/www.tuvsud.com\/en-us\/services\/product-certification\/nrtl<\/a><\/span><br \/>\n<span id=\"footnote-7\">7. CSA Group explique pourquoi l'homologation NRTL affecte l'approvisionnement hospitalier et les inspections des autorit\u00e9s comp\u00e9tentes (AHJ). <a href=\"#ref-7\">\ufe0e<\/a> \u2014 <a href=\"https:\/\/www.csagroup.org\">https:\/\/www.csagroup.org<\/a><\/span><br \/>\n<span id=\"footnote-8\">8. La norme NFPA 99 d\u00e9crit les attentes en mati\u00e8re d'\u00e9quipement \u00e9lectrique dans les \u00e9tablissements de sant\u00e9. <a href=\"#ref-8\">\ufe0e<\/a> \u2014 <a href=\"https:\/\/www.nfpa.org\/codes-and-standards\/all-codes-and-standards\/list-of-codes-and-standards\/detail?code=99\">https:\/\/www.nfpa.org\/codes-and-standards\/all-codes-and-standards\/list-of-codes-and-standards\/detail?code=99<\/a><\/span><br \/>\n<span id=\"footnote-9\">9. Pr\u00e9sentation de la norme ISO 13485 pour la conformit\u00e9 du syst\u00e8me de management de la qualit\u00e9 des dispositifs m\u00e9dicaux. <a href=\"#ref-9\">\ufe0e<\/a> \u2014 <a href=\"https:\/\/www.iso.org\/standard\/59752.html\">https:\/\/www.iso.org\/standard\/59752.html<\/a><\/span><br \/>\n<span id=\"footnote-10\">10. Liste officielle des exigences CEM de la norme IEC 60601-1-2. <a href=\"#ref-10\">\ufe0e<\/a> \u2014 <a href=\"https:\/\/webstore.iec.ch\/publication\/2612\">https:\/\/webstore.iec.ch\/publication\/2612<\/a><\/span><\/p>","protected":false},"excerpt":{"rendered":"<p>As the manufacturer, I get this question in almost every U.S. procurement call, so I\u2019ll lay out the practical and regulatory reality in plain English. 1 UL certification itself is not a statutory FDA requirement, but a recognized NRTL listing to IEC\/UL 60601-1 (and 60601-1-2 for EMC) is effectively mandatory for U.S. hospital acceptance, electrical [&hellip;]<\/p>\n","protected":false},"author":3,"featured_media":8416,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"default","adv-header-id-meta":"","stick-header-meta":"default","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"set","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"categories":[60],"tags":[],"class_list":["post-8412","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-shockwave-therapy-machine"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.0 (Yoast SEO v28.1) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Does the Shockwave Therapy Machine require UL certification? 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