{"id":8226,"date":"2025-10-15T08:12:43","date_gmt":"2025-10-15T08:12:43","guid":{"rendered":"https:\/\/kmslaser.com\/?p=8226"},"modified":"2025-10-19T12:53:56","modified_gmt":"2025-10-19T12:53:56","slug":"une-machine-de-therapie-par-ondes-de-choc-necessite-t-elle-une-validation-ou-des-tests-cliniques","status":"publish","type":"post","link":"https:\/\/kmslaser.com\/fr\/does-a-shockwave-therapy-machine-require-clinical-validation-or-testing\/","title":{"rendered":"Une machine de th\u00e9rapie par ondes de choc n\u00e9cessite-t-elle une validation ou des tests cliniques ?"},"content":{"rendered":"<p><iframe data-testid=\"embed-iframe\" style=\"border-radius:12px\" src=\"https:\/\/open.spotify.com\/embed\/episode\/122tzn2VQRZ368BUMd4Uzw?utm_source=generator&amp;theme=0\" width=\"100%\" height=\"152\" frameborder=\"0\" allowfullscreen=\"\" allow=\"autoplay; clipboard-write; encrypted-media; fullscreen; picture-in-picture\" loading=\"lazy\"><\/iframe><\/p>\n<p style=\"float: right; margin-left: 15px; margin-bottom: 15px;\">\n  <img decoding=\"async\" src=\"https:\/\/kmslaser.com\/wp-content\/uploads\/2025\/10\/1technician-in-a-certified-lab-performing-iec-60601.jpg\" alt=\"Ing\u00e9nieur de laboratoire teste un appareil \u00e0 ondes de choc dans un environnement de salle blanche (ID#1)\" class=\"top-image-square\">\n<\/p>\n<p>Je re\u00e7ois cette question dans presque toutes les demandes de mes clients : ces machines n\u00e9cessitent-elles une validation clinique r\u00e9elle avant que les h\u00f4pitaux ou les cliniques puissent les utiliser ? Oui, c'est le cas.<\/p>\n<p><strong>Oui. Les machines de th\u00e9rapie par ondes de choc sont des dispositifs m\u00e9dicaux. La plupart des march\u00e9s exigent une validation clinique et des tests de s\u00e9curit\u00e9 avant la vente ou l'importation. Le dispositif doit d\u00e9montrer des performances s\u00fbres, des contr\u00f4les de risque document\u00e9s et des preuves cliniques cr\u00e9dibles pour les indications d\u00e9clar\u00e9es.<\/strong><\/p>\n<p>Cet article explique les types de tests courants, les certifications applicables avant l'importation, comment v\u00e9rifier les affirmations et ce que la FDA attend. Il utilise un langage simple pour que les \u00e9quipes puissent briefer rapidement les parties prenantes.<\/p>\n<h2>Quels tests cliniques sont couramment requis ?<\/h2>\n<p>Je sugg\u00e8re toujours de commencer par un plan de test qui refl\u00e8te l'approbation que vous souhaitez. Cela permet d'\u00e9conomiser du temps et de retravailler plus tard.<\/p>\n<p><strong>Les exigences courantes comprennent les tests de s\u00e9curit\u00e9 et de performance en laboratoire, la biocompatibilit\u00e9 pour les pi\u00e8ces en contact avec le patient, la s\u00e9curit\u00e9 \u00e9lectrique et la CEM, la validation du logiciel et les preuves cliniques pour les indications pr\u00e9vues. Un suivi post-march\u00e9 est attendu apr\u00e8s le lancement.<\/strong><\/p>\n<p><img decoding=\"async\" src=\"https:\/\/kmslaser.com\/wp-content\/uploads\/2025\/10\/2infographic-listing-core-test-types-iec-60601-saf.jpg\" alt=\"Liste de contr\u00f4le de conformit\u00e9 m\u00e9dicale incluant IEC 60601 et ISO 10993 (ID#2)\" title=\"Normes r\u00e9glementaires\" \/><\/p>\n<p>Un programme complet combine des preuves non cliniques et cliniques. Les tests en laboratoire prouvent que le dispositif atteint ses objectifs et reste s\u00fbr. Les preuves cliniques montrent que de vrais patients en b\u00e9n\u00e9ficient lorsque des utilisateurs form\u00e9s suivent les instructions.<\/p>\n<h3>Tests non cliniques de base (typiques)<\/h3>\n<ul>\n<li><strong>S\u00e9curit\u00e9 \u00e9lectrique et CEM :<\/strong> Tests pour <a href=\"https:\/\/webstore.iec.ch\/publication\/2612\">IEC 60601-1<\/a> <sup><a href=\"#footnote-1\" id=\"ref-1\">1<\/a><\/sup> (s\u00e9curit\u00e9 de base) et <a href=\"https:\/\/en.wikipedia.org\/wiki\/IEC_60601#IEC_60601-1-2\">Internal Component Reliability Testing<\/a> <sup><a href=\"#footnote-2\" id=\"ref-2\">2<\/a><\/sup> (CEM), plus les normes collat\u00e9rales applicables.<\/li>\n<li><strong>Performance et calibration :<\/strong> V\u00e9rification de la densit\u00e9 de flux d'\u00e9nergie, de la pr\u00e9cision de la fr\u00e9quence, de la pr\u00e9cision du nombre d'impulsions et de la stabilit\u00e9 sur le cycle de service.<\/li>\n<li><strong>Cartographie de la sortie acoustique :<\/strong> Profondeur de focalisation, profil du faisceau et r\u00e9p\u00e9tabilit\u00e9 entre les lots ; m\u00e9thodes de calibration tra\u00e7ables.<\/li>\n<li><strong>Biocompatibilit\u00e9 (ISO 10993) :<\/strong> Mat\u00e9riaux des pi\u00e8ces en contact avec le patient test\u00e9s selon <a href=\"https:\/\/www.fda.gov\/medical-devices\/general-biocompatibility-guidance-and-resources\/use-international-standard-iso-10993-1\">ISO 10993<\/a> <sup><a href=\"#footnote-3\" id=\"ref-3\">3<\/a><\/sup>.<\/li>\n<li><strong>Ing\u00e9nierie de l'utilisabilit\u00e9 :<\/strong> Validation des facteurs humains pour <a href=\"https:\/\/webstore.iec.ch\/publication\/26873\">IEC 62366<\/a> <sup><a href=\"#footnote-4\" id=\"ref-4\">4<\/a><\/sup> pour les \u00e9crans, le flux de travail, les avertissements et les blocages.<\/li>\n<li><strong>Gestion des risques :<\/strong> Analyse des dangers et contr\u00f4les sous <a href=\"https:\/\/www.iso.org\/standard\/72704.html\">ISO 14971<\/a> <sup><a href=\"#footnote-5\" id=\"ref-5\">5<\/a><\/sup>.<\/li>\n<\/ul>\n<h3>Preuves cliniques (typique)<\/h3>\n<ul>\n<li><strong>\u00c9valuation clinique bas\u00e9e sur la litt\u00e9rature :<\/strong> Pour des indications bien \u00e9tablies utilisant des dispositifs \u00e9quivalents avec des sp\u00e9cifications techniques et des conditions d'utilisation correspondantes.<\/li>\n<li><strong>\u00c9tude clinique prospective :<\/strong> Lorsque les all\u00e9gations sont nouvelles, les param\u00e8tres diff\u00e8rent ou la litt\u00e9rature est insuffisante ; peut \u00eatre randomis\u00e9e ou une cohorte contr\u00f4l\u00e9e.<\/li>\n<li><strong>PMCF\/registre en conditions r\u00e9elles :<\/strong> Donn\u00e9es post-commercialisation confirmant le rapport b\u00e9n\u00e9fice\/risque en pratique courante.<\/li>\n<\/ul>\n<h3>Tableau 1 \u2014 Types de tests typiques par objectif<\/h3>\n<table>\n<thead>\n<tr>\n<th>Objectif<\/th>\n<th>Test ou document courant<\/th>\n<th>Ce que les r\u00e9viseurs recherchent<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>Prouver la s\u00e9curit\u00e9 \u00e9lectrique<\/td>\n<td>Rapport IEC 60601-1<\/td>\n<td>R\u00e9sultats de r\u00e9ussite, laboratoire accr\u00e9dit\u00e9<\/td>\n<\/tr>\n<tr>\n<td>Contr\u00f4ler les \u00e9missions\/l'immunit\u00e9<\/td>\n<td>Rapport IEC 60601-1-2<\/td>\n<td>Marges d'immunit\u00e9, journaux de r\u00e9ussite\/\u00e9chec<\/td>\n<\/tr>\n<tr>\n<td>V\u00e9rifier la sortie<\/td>\n<td>Tests acoustiques\/\u00e9nerg\u00e9tiques sur banc<\/td>\n<td>Bandes de tol\u00e9rance, tra\u00e7abilit\u00e9 de l'\u00e9talonnage<\/td>\n<\/tr>\n<tr>\n<td>Mat\u00e9riaux s\u00fbrs<\/td>\n<td>R\u00e9sum\u00e9 ISO 10993<\/td>\n<td>Classification des contacts, matrice de tests<\/td>\n<\/tr>\n<tr>\n<td>R\u00e9duire les erreurs d'utilisation<\/td>\n<td>Fichier IEC 62366<\/td>\n<td>Sc\u00e9narios de validation, mesures d'att\u00e9nuation<\/td>\n<\/tr>\n<tr>\n<td>Montrer le b\u00e9n\u00e9fice<\/td>\n<td>\u00c9valuation clinique \/ \u00e9tude<\/td>\n<td>Population, crit\u00e8res d'\u00e9valuation, statistiques, EAs<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>Une port\u00e9e claire et des crit\u00e8res d'acceptation document\u00e9s sont essentiels. Les examinateurs se concentrent sur la tra\u00e7abilit\u00e9 des risques aux tests en passant par les r\u00e9sultats.<\/p>\n<h2>Les certifications sont-elles obligatoires avant l'importation ?<\/h2>\n<p>On me demande une \u201c courte liste \u201d des certificats requis avant le d\u00e9part de la marchandise. C'est judicieux. Les documents manquants \u00e0 la douane co\u00fbtent cher.<\/p>\n<p><strong>Oui. La plupart des juridictions exigent des certifications ou des enregistrements sp\u00e9cifiques avant l'importation et la vente. Les \u00e9l\u00e9ments typiques comprennent le marquage CE dans le cadre du MDR de l'UE pour l'Europe, l'enregistrement\/l'autorisation de dispositif de la FDA pour les \u00c9tats-Unis, et des enregistrements sp\u00e9cifiques au pays ailleurs. Les rapports de s\u00e9curit\u00e9 (IEC 60601) et les r\u00e9sum\u00e9s de tests doivent \u00e9tayer la revendication.<\/strong><\/p>\n<p><img decoding=\"async\" src=\"https:\/\/kmslaser.com\/wp-content\/uploads\/2025\/10\/3flat-lay-photo-of-customs-documents-ce-certificat.jpg\" alt=\"Documentation technique CE et formulaires de conformit\u00e9 UE sur un presse-papiers (ID#3)\" title=\"Documents de certification CE\" \/><\/p>\n<p>Pour l'Europe, les fabricants compilent la Documentation Technique et un Rapport d'\u00c9valuation Clinique pour obtenir <strong>le marquage CE dans le cadre <a href=\"https:\/\/eur-lex.europa.eu\/eli\/reg\/2017\/745\/oj\">MDR UE 2017\/745<\/a><\/strong> <sup><a href=\"#footnote-6\" id=\"ref-6\">6<\/a><\/sup>. Aux \u00c9tats-Unis, la plupart des mod\u00e8les th\u00e9rapeutiques passent par le <strong>FDA <a href=\"https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfpmn\/pmn.cfm\">programme 510(k)<\/a><\/strong> <sup><a href=\"#footnote-7\" id=\"ref-7\">7<\/a><\/sup> avant la commercialisation.<\/p>\n<h3>Tableau 2 \u2014 Instantan\u00e9 de la pr\u00e9paration \u00e0 l'importation<\/h3>\n<table>\n<thead>\n<tr>\n<th>March\u00e9<\/th>\n<th>Indispensables avant l'importation<\/th>\n<th>Classe d'appareil typique<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>UE\/EEE<\/td>\n<td>CE selon le MDR + certificat d'organisme notifi\u00e9<\/td>\n<td>IIa\/IIb<\/td>\n<\/tr>\n<tr>\n<td>\u00c9tats-Unis<\/td>\n<td>510(k) ou de novo + enregistrement<\/td>\n<td>II<\/td>\n<\/tr>\n<tr>\n<td>Royaume-Uni<\/td>\n<td>UKCA ou CE accept\u00e9 + enregistrement MHRA<\/td>\n<td>IIa\/IIb<\/td>\n<\/tr>\n<tr>\n<td>Canada<\/td>\n<td>MDL + MDSAP<\/td>\n<td>II<\/td>\n<\/tr>\n<tr>\n<td>Australie<\/td>\n<td>Inscription ARTG<\/td>\n<td>IIa\/IIb<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>Si un appareil est exp\u00e9di\u00e9 sans ces \u00e9l\u00e9ments, les douanes ou les r\u00e9gulateurs peuvent le retenir, le sanctionner ou exiger sa r\u00e9exportation. Les distributeurs doivent v\u00e9rifier les certificats par rapport aux bases de donn\u00e9es publiques lorsque disponibles.<\/p>\n<h2>Comment v\u00e9rifier les rapports de validation clinique ?<\/h2>\n<p>On me demande souvent : \u201c Comment savoir si le dossier clinique est r\u00e9el et pertinent ? \u201d Une liste de contr\u00f4le simple et neutre aide les deux parties.<\/p>\n<p><strong>La v\u00e9rification signifie contr\u00f4ler l'authenticit\u00e9, la pertinence et la tra\u00e7abilit\u00e9. Les acheteurs doivent confirmer les laboratoires d'essai accr\u00e9dit\u00e9s, l'identit\u00e9 coh\u00e9rente de l'appareil, les indications correspondantes et les donn\u00e9es compl\u00e8tes. La litt\u00e9rature ind\u00e9pendante doit \u00e9tayer les m\u00eames param\u00e8tres.<\/strong><\/p>\n<p><img decoding=\"async\" src=\"https:\/\/kmslaser.com\/wp-content\/uploads\/2025\/10\/4infographic-showing-verification-workflow-identif.jpg\" alt=\"Infographie de liste de contr\u00f4le montrant le processus d&#039;approbation des dispositifs m\u00e9dicaux (ID#4)\" title=\"Flux d&#039;approbation\" \/><\/p>\n<p>Confirmer la port\u00e9e d'accr\u00e9ditation du laboratoire d'essai \u00e0 <strong><a href=\"https:\/\/www.iso.org\/standard\/66912.html\">ISO\/IEC 17025<\/a><\/strong> <sup><a href=\"#footnote-8\" id=\"ref-8\">8<\/a><\/sup>, et valider le num\u00e9ro de l'organisme notifi\u00e9 dans l'UE via la <strong><a href=\"https:\/\/webgate.ec.europa.eu\/nando\/\">Base de donn\u00e9es NANDO<\/a><\/strong> <sup><a href=\"#footnote-9\" id=\"ref-9\">9<\/a><\/sup>.<\/p>\n<h3>Un flux de travail de v\u00e9rification pratique<\/h3>\n<ol>\n<li>Identifier clairement l'appareil : faire correspondre le nom commercial, le mod\u00e8le, la version mat\u00e9rielle et la version logicielle dans tous les documents.<\/li>\n<li>V\u00e9rifier la cr\u00e9dibilit\u00e9 du laboratoire : accr\u00e9ditation et \u00e9ditions correctes des normes dans les rapports.<\/li>\n<li>Mapper les risques aux tests : aligner les dangers ISO 14971 avec les preuves de v\u00e9rification\/validation.<\/li>\n<li>Valider la pertinence clinique : confirmer l'\u00e9quivalence des plages de sortie, du type d'onde et de la population de patients.<\/li>\n<li>Confirmer la fra\u00eecheur des donn\u00e9es : g\u00e9n\u00e9ration actuelle du micrologiciel\/pi\u00e8ce \u00e0 main r\u00e9f\u00e9renc\u00e9e.<\/li>\n<li>Croiser les d\u00e9clarations : la D\u00e9claration de Conformit\u00e9, les certificats de l'Organisme Notifi\u00e9 ou les r\u00e9sum\u00e9s 510(k) listent le m\u00eame mod\u00e8le et les m\u00eames indications.<\/li>\n<\/ol>\n<h2>Les r\u00e8gles de la FDA exigent-elles des tests cliniques ?<\/h2>\n<p>On me demande souvent : \u201c La FDA nous obligera-t-elle toujours \u00e0 r\u00e9aliser de nouveaux essais cliniques ? \u201d La r\u00e9ponse d\u00e9pend de l'appareil, de l'indication et du pr\u00e9dicat.<\/p>\n<p><strong>Pour de nombreuses machines de lithotripsie, la voie d'acc\u00e8s de la FDA est le 510(k). Des donn\u00e9es cliniques peuvent \u00eatre requises ou non. Si l'appareil correspond \u00e0 un pr\u00e9dicat en termes de technologie et d'indications, des preuves de laboratoire et de litt\u00e9rature peuvent suffire. Si les revendications ou la technologie sont nouvelles, des \u00e9tudes cliniques sont souvent requises.<\/strong><\/p>\n<p><img decoding=\"async\" src=\"https:\/\/kmslaser.com\/wp-content\/uploads\/2025\/10\/5flat-lay-photo-of-fda-clearance-letter-510-k-app.jpg\" alt=\"Document FDA 510(k) \u00e0 c\u00f4t\u00e9 d&#039;un appareil m\u00e9dical approuv\u00e9 (ID#5)\" title=\"Autorisation de la FDA\" \/><\/p>\n<p>Pour minimiser l'incertitude, les \u00e9quipes demandent souvent une <strong><a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/q-submissions-program\">R\u00e9union Q-Submission (Pre-Sub)<\/a><\/strong> avec les examinateurs de la FDA pour s'aligner sur les attentes en mati\u00e8re de preuves. <sup><a href=\"#footnote-10\" id=\"ref-10\">10<\/a><\/sup>.<\/p>\n<h3>Tableau 3 \u2014 Quand la FDA s'attend souvent \u00e0 des donn\u00e9es cliniques<\/h3>\n<table>\n<thead>\n<tr>\n<th>Situation<\/th>\n<th>Probabilit\u00e9 de besoin de donn\u00e9es cliniques<\/th>\n<th>Notes<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>M\u00eame technologie + m\u00eame indication que le pr\u00e9dicat<\/td>\n<td>Faible<\/td>\n<td>Solides preuves de laboratoire + litt\u00e9rature peuvent suffire<\/td>\n<\/tr>\n<tr>\n<td>Nouvelle indication, m\u00eame technologie<\/td>\n<td>Moyen<\/td>\n<td>Preuves cliniques cibl\u00e9es probables<\/td>\n<\/tr>\n<tr>\n<td>Nouvelles fonctionnalit\u00e9s technologiques (par exemple, modalit\u00e9 combin\u00e9e)<\/td>\n<td>Haut<\/td>\n<td>Travaux cliniques + travaux de laboratoire \u00e9tendus<\/td>\n<\/tr>\n<tr>\n<td>Revendications de sup\u00e9riorit\u00e9 \u00e9largies<\/td>\n<td>Haut<\/td>\n<td>Donn\u00e9es comparatives prospectives<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<hr \/>\n<h2>Conclusion<\/h2>\n<p>Oui, la validation clinique est importante. Planifiez les tests de laboratoire, les normes de s\u00e9curit\u00e9 et les preuves appropri\u00e9es pour le march\u00e9 choisi. V\u00e9rifiez attentivement les rapports, alignez les revendications sur les approbations et utilisez les commentaires pr\u00e9coces de la FDA ou de l'Organisme Notifi\u00e9 pour rester sur la bonne voie.<\/p>\n<hr \/>\n<h2>Notes de bas de page<\/h2>\n<p><span id=\"footnote-1\">1. IEC 60601-1 \u2014 Norme de s\u00e9curit\u00e9 \u00e9lectrique\/m\u00e9canique de base pour les dispositifs m\u00e9dicaux. <a href=\"#ref-1\">\ufe0e<\/a><\/span><br \/>\n<span id=\"footnote-2\">2. IEC 60601-1-2 \u2014 Exigences et tests de compatibilit\u00e9 \u00e9lectromagn\u00e9tique. <a href=\"#ref-2\">\ufe0e<\/a><\/span><br \/>\n<span id=\"footnote-3\">3. ISO 10993 \u2014 Cadre reconnu par la FDA pour l'\u00e9valuation de la biocompatibilit\u00e9. <a href=\"#ref-3\">\ufe0e<\/a><\/span><br \/>\n<span id=\"footnote-4\">4. IEC 62366 \u2014 Ing\u00e9nierie de l'utilisabilit\u00e9 pour r\u00e9duire les risques li\u00e9s \u00e0 l'utilisation. <a href=\"#ref-4\">\ufe0e<\/a><\/span><br \/>\n<span id=\"footnote-5\">5. ISO 14971 \u2014 Processus de gestion des risques pour les dispositifs m\u00e9dicaux. <a href=\"#ref-5\">\ufe0e<\/a><\/span><br \/>\n<span id=\"footnote-6\">6. MDR UE 2017\/745 \u2014 Base l\u00e9gale pour le marquage CE et l'\u00e9valuation clinique. <a href=\"#ref-6\">\ufe0e<\/a><\/span><br \/>\n<span id=\"footnote-7\">7. FDA 510(k) \u2014 Base de donn\u00e9es pour v\u00e9rifier les autorisations d'\u00e9quivalence substantielle. <a href=\"#ref-7\">\ufe0e<\/a><\/span><br \/>\n<span id=\"footnote-8\">8. ISO\/IEC 17025 \u2014 Accr\u00e9ditation pour la comp\u00e9tence des laboratoires d'essais\/\u00e9talonnage. <a href=\"#ref-8\">\ufe0e<\/a><\/span><br \/>\n<span id=\"footnote-9\">9. NANDO \u2014 Annuaire de l'UE pour v\u00e9rifier les Organismes Notifi\u00e9s et leurs domaines de comp\u00e9tence. <a href=\"#ref-9\">\ufe0e<\/a><\/span><br \/>\n<span id=\"footnote-10\">10. FDA Q-Submission \u2014 Processus pour obtenir des commentaires avant la mise sur le march\u00e9 sur les plans de preuves. <a href=\"#ref-10\">\ufe0e<\/a><\/span>  <\/p>","protected":false},"excerpt":{"rendered":"<p>I get this question in almost every inquiry from the my customers: do these machines need real clinical validation before hospitals or clinics can use them? Yes, they do. Yes. Shockwave therapy machines are medical devices. Most markets require clinical validation and safety testing before sale or import. 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