{"id":8459,"date":"2025-11-26T23:36:50","date_gmt":"2025-11-26T23:36:50","guid":{"rendered":"https:\/\/kmslaser.com\/?p=8459"},"modified":"2025-11-26T23:36:50","modified_gmt":"2025-11-26T23:36:50","slug":"lors-de-lachat-dune-machine-de-traitement-par-ondes-de-choc-le-fournisseur-est-il-tenu-de-fournir-des-rapports-de-tests-de-securite-cutanee","status":"publish","type":"post","link":"https:\/\/kmslaser.com\/fr\/when-purchasing-a-shockwave-therapy-machine-is-the-supplier-required-to-provide-skin-safety-testing-reports\/","title":{"rendered":"Lors de l'achat d'une machine de th\u00e9rapie par ondes de choc, le fournisseur est-il tenu de fournir des rapports de tests de s\u00e9curit\u00e9 cutan\u00e9e ?"},"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-detailed-close-up-of-a-shockwave-therapy-handpie.jpg\" alt=\"Pi\u00e8ce \u00e0 main m\u00e9dicale \u00e0 c\u00f4t\u00e9 de documents de test de biocompatibilit\u00e9 et de s\u00e9curit\u00e9 cutan\u00e9e (ID#1)\" class=\"top-image-square\">\n<\/p>\n<p>De notre c\u00f4t\u00e9, en tant qu'entreprise qui construit ces syst\u00e8mes, les acheteurs nous demandent souvent si nous devons prouver la s\u00e9curit\u00e9 cutan\u00e9e par <strong><a href=\"https:\/\/platform.ubora-biomedical.org\/resources\/937676d7-9a48-4867-a491-f2bb8edad2ba\">des preuves de biocompatibilit\u00e9 pour les dispositifs m\u00e9dicaux<\/a><\/strong> <sup><a href=\"#footnote-1\" id=\"ref-1\">1<\/a><\/sup>, ou si une marque CE ou FDA couvre d\u00e9j\u00e0 tout.<\/p>\n<p><strong>Les fournisseurs de machines de th\u00e9rapie par ondes de choc ne sont pas toujours l\u00e9galement oblig\u00e9s de remettre un \u201c rapport de s\u00e9curit\u00e9 cutan\u00e9e \u201d autonome, mais ils doivent d\u00e9tenir et, sur demande, partager des preuves de biocompatibilit\u00e9 d\u00e9montrant que tous les mat\u00e9riaux en contact avec le patient sont s\u00fbrs pour une exposition cutan\u00e9e r\u00e9p\u00e9t\u00e9e.<\/strong><\/p>\n<p>Si vous consid\u00e9rez cela comme un simple achat d'appareil cosm\u00e9tique, vous pouvez facilement manquer de s\u00e9rieux risques r\u00e9glementaires et de responsabilit\u00e9 li\u00e9s \u00e0 la s\u00e9curit\u00e9 du contact cutan\u00e9.<\/p>\n<hr \/>\n<h2>Quels types de tests de compatibilit\u00e9 cutan\u00e9e sont courants dans l'industrie ?<\/h2>\n<p>En travaillant avec des laboratoires d'essais et des consultants r\u00e9glementaires, nous constatons que de nombreux acheteurs sous-estiment \u00e0 quel point les tests de compatibilit\u00e9 cutan\u00e9e sont structur\u00e9s et standardis\u00e9s pour les pi\u00e8ces \u00e0 main et les accessoires de th\u00e9rapie par ondes de choc.<\/p>\n<p><strong>Les tests de compatibilit\u00e9 cutan\u00e9e les plus courants suivent la s\u00e9rie ISO 10993 et comprennent la cytotoxicit\u00e9, l'irritation, la sensibilisation et parfois la caract\u00e9risation des mat\u00e9riaux, formant un ensemble de biocompatibilit\u00e9 qui prouve que la pi\u00e8ce \u00e0 main et les accessoires sont s\u00fbrs pour le contact avec la peau intacte.<\/strong><\/p>\n<p><img decoding=\"async\" src=\"https:\/\/kmslaser.com\/wp-content\/uploads\/2025\/11\/2a-modern-testing-laboratory-where-sample-pieces-fr.jpg\" alt=\"Laboratoire effectuant des tests de biocompatibilit\u00e9 ISO avec des plateaux de mat\u00e9riaux \u00e9tiquet\u00e9s (ID#2)\" title=\"Tests en laboratoire\" \/><\/p>\n<p>Pour les dispositifs externes tels que les machines de th\u00e9rapie par ondes de choc, la principale pr\u00e9occupation est la fa\u00e7on dont les mat\u00e9riaux se comportent lors de contacts r\u00e9p\u00e9t\u00e9s avec la peau intacte au fil du temps, ce qui est exactement l'objectif de <strong><a href=\"https:\/\/www.fda.gov\/media\/142959\/download\">la norme de biocompatibilit\u00e9 ISO 10993-1<\/a><\/strong> <sup><a href=\"#footnote-2\" id=\"ref-2\">2<\/a><\/sup>. M\u00eame si l'\u00e9nergie est d\u00e9livr\u00e9e par air ou par gel, la coque de la pi\u00e8ce \u00e0 main, les capuchons et les surfaces de couplage sont tous importants.<\/p>\n<h3>Batterie de tests ISO 10993 typique pour peau intacte<\/h3>\n<p>Les r\u00e9gulateurs attendent des fabricants qu'ils suivent une approche bas\u00e9e sur le risque, guid\u00e9e par <strong><a href=\"https:\/\/www.fda.gov\/medical-devices\/biocompatibility-assessment-resource-center\/biocompatibility-evaluation-endpoints-device-category\">les points d'\u00e9valuation de la biocompatibilit\u00e9 par cat\u00e9gorie de dispositif<\/a><\/strong> <sup><a href=\"#footnote-3\" id=\"ref-3\">3<\/a><\/sup>, mais de nombreux dispositifs utilisent un ensemble minimum standard de tests, r\u00e9sum\u00e9 dans <strong><a href=\"https:\/\/www.emergobyul.com\/sites\/default\/files\/2023-08\/PLC23CS1070961-ISO-Biocompatibility-Whitepaper_Final-Digital.pdf\">les aper\u00e7us de la s\u00e9rie ISO 10993 sur la biocompatibilit\u00e9<\/a><\/strong> <sup><a href=\"#footnote-10\" id=\"ref-10\">10<\/a><\/sup>:<\/p>\n<ul>\n<li><strong>Cytotoxicit\u00e9<\/strong> \u2013 v\u00e9rifie si les mat\u00e9riaux sont toxiques pour les cellules  <\/li>\n<li><strong>Irritation<\/strong> \u2013 \u00e9value si le contact provoque des rougeurs ou une inflammation  <\/li>\n<li><strong>Sensibilisation<\/strong> \u2013 \u00e9value le risque de r\u00e9actions allergiques  <\/li>\n<li><strong>Caract\u00e9risation des mat\u00e9riaux<\/strong> \u2013 identifie les ingr\u00e9dients et les substances potentiellement extractibles  <\/li>\n<li><strong>Observations cliniques ou d'utilisabilit\u00e9<\/strong> \u2013 surveille les r\u00e9actions cutan\u00e9es locales en cours d'utilisation<\/li>\n<\/ul>\n<p>Ensemble, ces \u00e9l\u00e9ments donnent une image claire de la s\u00e9curit\u00e9 des parties en contact avec le patient.<\/p>\n<h3>M\u00e9thodes de test courantes en un coup d'\u0153il<\/h3>\n<table>\n<thead>\n<tr>\n<th>Type de test<\/th>\n<th>Objectif<\/th>\n<th>Typique pour les appareils \u00e0 ondes de choc<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>Cytotoxicit\u00e9<\/td>\n<td>D\u00e9tecte la cytotoxicit\u00e9 cellulaire<\/td>\n<td>Oui, standard<\/td>\n<\/tr>\n<tr>\n<td>Irritation<\/td>\n<td>V\u00e9rifie les rougeurs \/ gonflements<\/td>\n<td>Oui, standard<\/td>\n<\/tr>\n<tr>\n<td>Sensibilisation<\/td>\n<td>\u00c9value le potentiel allerg\u00e8ne<\/td>\n<td>Oui, fortement recommand\u00e9<\/td>\n<\/tr>\n<tr>\n<td>Analyse des mat\u00e9riaux<\/td>\n<td>Identifie les produits chimiques et les substances relargables<\/td>\n<td>Souvent inclus<\/td>\n<\/tr>\n<tr>\n<td>Suivi clinique<\/td>\n<td>Observe les r\u00e9actions lors d'une utilisation r\u00e9elle<\/td>\n<td>Parfois, selon les all\u00e9gations<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<hr \/>\n<h2>Comment les acheteurs peuvent-ils s'assurer que la pi\u00e8ce \u00e0 main est s\u00fbre pour un contact direct avec la peau ?<\/h2>\n<p>D'apr\u00e8s notre exp\u00e9rience d'accompagnement des propri\u00e9taires de marques, les acheteurs les plus performants ne se contentent pas de faire confiance au catalogue. Ils posent des questions intelligentes et sp\u00e9cifiques sur la s\u00e9curit\u00e9 du contact cutan\u00e9 et demandent des preuves avant de confirmer les commandes.<\/p>\n<p><strong>Les acheteurs peuvent garantir la s\u00e9curit\u00e9 cutan\u00e9e des pi\u00e8ces \u00e0 main en demandant des donn\u00e9es de biocompatibilit\u00e9 ISO 10993, en v\u00e9rifiant que tous les mat\u00e9riaux en contact avec le patient sont document\u00e9s, en examinant les retours cliniques ou post-march\u00e9, et en confirmant que la conception favorise une utilisation hygi\u00e9nique sans bords tranchants, rev\u00eatements toxiques ou surfaces non hygi\u00e9niques.<\/strong><\/p>\n<p><img decoding=\"async\" src=\"https:\/\/kmslaser.com\/wp-content\/uploads\/2025\/11\/3a-high-resolution-close-up-of-the-handpiece-detail.jpg\" alt=\"Pi\u00e8ce \u00e0 main m\u00e9dicale expos\u00e9e avec documentation sur la tra\u00e7abilit\u00e9 des mat\u00e9riaux et la s\u00e9curit\u00e9 (ID#3)\" title=\"Mat\u00e9riaux des dispositifs\" \/><\/p>\n<p>Une pi\u00e8ce \u00e0 main s\u00fbre ne se r\u00e9sume pas aux rapports de test. Il s'agit \u00e9galement des mat\u00e9riaux, de l'ergonomie et de la mani\u00e8re dont l'appareil se comporte dans l'utilisation quotidienne en salon ou en clinique, ce qui devrait refl\u00e9ter les principes de <strong><a href=\"https:\/\/www.medtechdive.com\/news\/fda-final-guidance-biocompatibility-device-skin\/693649\/\">FDA guidance for devices contacting intact skin<\/a><\/strong> <sup><a href=\"#footnote-4\" id=\"ref-4\">4<\/a><\/sup>.<\/p>\n<h3>Practical steps to verify skin safety<\/h3>\n<ol>\n<li><strong>Request the biocompatibility summary<\/strong>  <\/li>\n<li><strong>Confirm material documentation<\/strong>  <\/li>\n<li><strong>Check design for hygiene<\/strong>  <\/li>\n<li><strong>Review user feedback and complaints<\/strong>  <\/li>\n<\/ol>\n<h3>Buyer verification checklist<\/h3>\n<table>\n<thead>\n<tr>\n<th>Verification Step<\/th>\n<th>What to Ask Supplier<\/th>\n<th>What It Confirms<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>Biocompatibility evidence<\/td>\n<td>\u201cDo you have <strong><a href=\"https:\/\/tsquality.ch\/eu-mdrs-bio-compatibility-requirements-for-medical-devices-iso-10993\/\">ISO 10993 skin-contact tests<\/a><\/strong>?\u201d <sup><a href=\"#footnote-5\" id=\"ref-5\">5<\/a><\/sup><\/td>\n<td>Formal skin safety evaluation<\/td>\n<\/tr>\n<tr>\n<td>Material list for contact areas<\/td>\n<td>\u201cWhat plastics and metals touch the skin?\u201d<\/td>\n<td>Transparence sur les choix de mat\u00e9riaux<\/td>\n<\/tr>\n<tr>\n<td>Instructions de nettoyage et de d\u00e9sinfection<\/td>\n<td>\u201c Comment nettoyer l'instrument en toute s\u00e9curit\u00e9 ? \u201d<\/td>\n<td>Hygi\u00e8ne pratique et durabilit\u00e9 du rev\u00eatement<\/td>\n<\/tr>\n<tr>\n<td>Historique des plaintes<\/td>\n<td>\u201c Des cas d'irritation cutan\u00e9e ont-ils \u00e9t\u00e9 signal\u00e9s par le pass\u00e9 ? \u201d<\/td>\n<td>Performances r\u00e9elles et historique des risques<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<hr \/>\n<h2>Des certifications sp\u00e9cifiques sont-elles requises pour les march\u00e9s esth\u00e9tiques par rapport aux march\u00e9s m\u00e9dicaux ?<\/h2>\n<p>Parce que nous fournissons des clients des secteurs m\u00e9dical et esth\u00e9tique, nous constatons un \u00e9cart clair entre ce que certains acheteurs du secteur de la beaut\u00e9 consid\u00e8rent comme \u201c suffisant \u201d et ce que les r\u00e9gulateurs exigent pour les v\u00e9ritables dispositifs m\u00e9dicaux.<\/p>\n<p><strong>Les march\u00e9s m\u00e9dicaux exigent g\u00e9n\u00e9ralement une autorisation r\u00e9glementaire compl\u00e8te (telle que le marquage CE selon le MDR ou le 510(k) de la FDA), qui comprend des preuves de biocompatibilit\u00e9, tandis que les march\u00e9s purement esth\u00e9tiques peuvent n'accepter que la s\u00e9curit\u00e9 \u00e9lectrique et une documentation de base \u2014 mais s'appuyer uniquement sur des normes esth\u00e9tiques minimales augmente consid\u00e9rablement les risques.<\/strong><\/p>\n<p><img decoding=\"async\" src=\"https:\/\/kmslaser.com\/wp-content\/uploads\/2025\/11\/4a-high-end-regulatory-desk-with-folders-labeled-c.jpg\" alt=\"Classeurs empil\u00e9s de conformit\u00e9 CE MDR, ISO 13485 et ISO 10993 en laboratoire (ID#4)\" title=\"Dossiers de conformit\u00e9\" \/><\/p>\n<p>Pour les dispositifs m\u00e9dicaux, le marquage CE doit suivre <strong><a href=\"https:\/\/decomplix.com\/medical-device-ce-marking-guide\/\">les processus de marquage CE du MDR de l'UE<\/a><\/strong> <sup><a href=\"#footnote-6\" id=\"ref-6\">6<\/a><\/sup>, et les dispositifs de la FDA peuvent n\u00e9cessiter <strong><a href=\"https:\/\/www.fda.gov\/medical-devices\/premarket-notification-510k\/special-considerations-510ks\">une notification pr\u00e9alable \u00e0 la mise sur le march\u00e9 510(k) de la FDA<\/a><\/strong> <sup><a href=\"#footnote-7\" id=\"ref-7\">7<\/a><\/sup>, tous deux s'attendant \u00e0 une justification appropri\u00e9e de la biocompatibilit\u00e9.<\/p>\n<h3>Comparaison des attentes m\u00e9dicales et esth\u00e9tiques<\/h3>\n<table>\n<thead>\n<tr>\n<th>Type de march\u00e9<\/th>\n<th>Exigences typiques<\/th>\n<th>Implication pour la s\u00e9curit\u00e9 de la peau<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>M\u00e9dical (MDR UE)<\/td>\n<td>Marquage CE, <strong><a href=\"https:\/\/www.iso.org\/iso-13485-medical-devices.html\">Syst\u00e8me de management de la qualit\u00e9 ISO 13485<\/a><\/strong> <sup><a href=\"#footnote-8\" id=\"ref-8\">8<\/a><\/sup>, ISO 10993, preuves cliniques<\/td>\n<td>Contr\u00f4le rigoureux de la biocompatibilit\u00e9<\/td>\n<\/tr>\n<tr>\n<td>M\u00e9dical (FDA US)<\/td>\n<td>510(k), <strong><a href=\"https:\/\/www.fda.gov\/medical-devices\/biocompatibility-assessment-resource-center\/biocompatibility-evaluation-endpoints-device-category\">Guide de la FDA sur la biocompatibilit\u00e9<\/a><\/strong> <sup><a href=\"#footnote-3\" id=\"ref-3\">3<\/a><\/sup><\/td>\n<td>Tests cutan\u00e9s attendus pour les pi\u00e8ces en contact<\/td>\n<\/tr>\n<tr>\n<td>Esth\u00e9tique (usage pro)<\/td>\n<td>S\u00e9curit\u00e9 \u00e9lectrique, CEM<\/td>\n<td>Biocompatibilit\u00e9 souvent demand\u00e9e par les acheteurs<\/td>\n<\/tr>\n<tr>\n<td>Esth\u00e9tique (domicile)<\/td>\n<td>Normes minimales<\/td>\n<td>Risque plus \u00e9lev\u00e9 si les donn\u00e9es de s\u00e9curit\u00e9 cutan\u00e9e sont manquantes<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<hr \/>\n<h2>Quels sont les risques si les donn\u00e9es de s\u00e9curit\u00e9 cutan\u00e9e sont manquantes ?<\/h2>\n<p>D'apr\u00e8s les discussions en usine et r\u00e9glementaires, nous avons constat\u00e9 que rogner sur la documentation de s\u00e9curit\u00e9 cutan\u00e9e est l'un des moyens les plus rapides pour les marques de se retrouver dans de s\u00e9rieux ennuis, tant sur le plan clinique que juridique.<\/p>\n<p><strong>Le manque de donn\u00e9es de s\u00e9curit\u00e9 cutan\u00e9e augmente le risque d'irritation du patient, de r\u00e9actions allergiques, de rappels de produits, de responsabilit\u00e9 l\u00e9gale, de refus d'importation et de dommages \u00e0 long terme \u00e0 la r\u00e9putation de la marque.<\/strong><\/p>\n<p><img decoding=\"async\" src=\"https:\/\/kmslaser.com\/wp-content\/uploads\/2025\/11\/5a-modern-testing-laboratory-where-sample-pieces-fr.jpg\" alt=\"Pi\u00e8ce \u00e0 main m\u00e9dicale sur des documents d&#039;\u00e9valuation de la biocompatibilit\u00e9 et de la s\u00e9curit\u00e9 cutan\u00e9e (ID#5)\" title=\"Tests de s\u00e9curit\u00e9\" \/><\/p>\n<p>Le risque augmente \u00e9galement lorsque les fabricants ignorent les attentes \u00e9volutives telles que la <strong><a href=\"https:\/\/www.hoganlovells.com\/en\/publications\/update-to-biocompatibility-policy-for-medical-devices-in-contact-with-intact-skin\">mise \u00e0 jour de la politique de biocompatibilit\u00e9 pour les dispositifs en contact avec la peau<\/a><\/strong> <sup><a href=\"#footnote-9\" id=\"ref-9\">9<\/a><\/sup>, qui clarifie quand la justification plut\u00f4t que les tests est acceptable.<\/p>\n<h3>Tableau r\u00e9capitulatif des risques<\/h3>\n<table>\n<thead>\n<tr>\n<th>Cat\u00e9gorie de risque<\/th>\n<th>Exemple de cons\u00e9quence<\/th>\n<th>Niveau d'impact<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>Clinique<\/td>\n<td>Irritation, allergie, l\u00e9sions cutan\u00e9es locales<\/td>\n<td>Haut<\/td>\n<\/tr>\n<tr>\n<td>R\u00e9glementaire<\/td>\n<td>Refus d'importation, suspension des ventes<\/td>\n<td>Haut<\/td>\n<\/tr>\n<tr>\n<td>Financier<\/td>\n<td>Retours, demandes de garantie, rappels<\/td>\n<td>Moyen-\u00e9lev\u00e9<\/td>\n<\/tr>\n<tr>\n<td>R\u00e9putationnel<\/td>\n<td>Perte de confiance avec les cliniques et les patients<\/td>\n<td>Haut<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<hr \/>\n<h2>Conclusion<\/h2>\n<p>Lors de l'achat d'une machine de th\u00e9rapie par ondes de choc, les acheteurs doivent consid\u00e9rer les preuves de s\u00e9curit\u00e9 cutan\u00e9e comme essentielles, demander une documentation de biocompatibilit\u00e9 bas\u00e9e sur la norme ISO 10993 et comprendre que l'absence de telles donn\u00e9es les expose \u00e0 des risques cliniques, r\u00e9glementaires et de r\u00e9putation sur les march\u00e9s m\u00e9dical et esth\u00e9tique.<\/p>\n<hr \/>\n<h2>Notes de bas de page<\/h2>\n<p><span id=\"footnote-1\">1. Aper\u00e7u des concepts de biocompatibilit\u00e9 des dispositifs m\u00e9dicaux pour le contact cutan\u00e9. <a href=\"#ref-1\">\ufe0e<\/a><\/span><br \/>\n<span id=\"footnote-2\">2. Document d'orientation sur la biocompatibilit\u00e9 ISO 10993 h\u00e9berg\u00e9 par la FDA. <a href=\"#ref-2\">\ufe0e<\/a><\/span><br \/>\n<span id=\"footnote-3\">3. Matrice des points d'extr\u00e9mit\u00e9 de biocompatibilit\u00e9 de la FDA par cat\u00e9gorie de dispositif. <a href=\"#ref-3\">\ufe0e<\/a><\/span><br \/>\n<span id=\"footnote-4\">4. R\u00e9sum\u00e9 des actualit\u00e9s sur les directives de la FDA concernant la biocompatibilit\u00e9 pour le contact cutan\u00e9. <a href=\"#ref-4\">\ufe0e<\/a><\/span><br \/>\n<span id=\"footnote-5\">5. Article sur les exigences de la MDR europ\u00e9enne en mati\u00e8re de biocompatibilit\u00e9 et la norme ISO 10993. <a href=\"#ref-5\">\ufe0e<\/a><\/span><br \/>\n<span id=\"footnote-6\">6. Guide pratique du marquage CE dans le cadre de la MDR europ\u00e9enne. <a href=\"#ref-6\">\ufe0e<\/a><\/span><br \/>\n<span id=\"footnote-7\">7. Page de la FDA d\u00e9crivant les consid\u00e9rations sp\u00e9ciales de biocompatibilit\u00e9 pour les 510(k). <a href=\"#ref-7\">\ufe0e<\/a><\/span><br \/>\n<span id=\"footnote-8\">8. Aper\u00e7u de la norme ISO 13485 sur les syst\u00e8mes de management de la qualit\u00e9 des dispositifs m\u00e9dicaux. <a href=\"#ref-8\">\ufe0e<\/a><\/span><br \/>\n<span id=\"footnote-9\">9. Analyse juridique de la politique mise \u00e0 jour sur la biocompatibilit\u00e9 pour les dispositifs \u00e0 peau intacte. <a href=\"#ref-9\">\ufe0e<\/a><\/span><br \/>\n<span id=\"footnote-10\">10. Livre blanc expliquant la s\u00e9rie ISO 10993 sur la biocompatibilit\u00e9 et la planification des tests. <a href=\"#ref-10\">\ufe0e<\/a><\/span>  <\/p>","protected":false},"excerpt":{"rendered":"<p>From our side as a company that builds these systems, buyers often ask whether we must prove skin safety through biocompatibility evidence for medical devices 1, or if a CE or FDA mark alone already covers everything. Suppliers of shockwave therapy machines are not always legally forced to hand over a stand-alone \u201cskin-safety report\u201d, but [&hellip;]<\/p>\n","protected":false},"author":3,"featured_media":8460,"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-8459","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>When purchasing a Shockwave Therapy Machine, is the supplier required to provide skin-safety testing reports? - KMSLaser<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/kmslaser.com\/fr\/lors-de-lachat-dune-machine-de-traitement-par-ondes-de-choc-le-fournisseur-est-il-tenu-de-fournir-des-rapports-de-tests-de-securite-cutanee\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"When purchasing a Shockwave Therapy Machine, is the supplier required to provide skin-safety testing reports?\" \/>\n<meta property=\"og:description\" content=\"From our side as a company that builds these systems, buyers often ask whether we must prove skin safety through biocompatibility evidence for medical devices 1, or if a CE or FDA mark alone already covers everything. 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