{"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":"al-adquirir-una-maquina-de-terapia-de-ondas-de-choque-el-proveedor-esta-obligado-a-proporcionar-informes-de-pruebas-de-seguridad-cutanea","status":"publish","type":"post","link":"https:\/\/kmslaser.com\/es\/when-purchasing-a-shockwave-therapy-machine-is-the-supplier-required-to-provide-skin-safety-testing-reports\/","title":{"rendered":"Al adquirir una m\u00e1quina de terapia por ondas de choque, \u00bfel proveedor est\u00e1 obligado a proporcionar informes de pruebas de seguridad para la piel?"},"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=\"Pieza de mano m\u00e9dica junto con documentos de pruebas de biocompatibilidad y seguridad cut\u00e1nea (ID#1)\" class=\"top-image-square\">\n<\/p>\n<p>Desde nuestra perspectiva como empresa que fabrica estos sistemas, los compradores a menudo nos preguntan si debemos demostrar la seguridad para la piel a trav\u00e9s de <strong><a href=\"https:\/\/platform.ubora-biomedical.org\/resources\/937676d7-9a48-4867-a491-f2bb8edad2ba\">Evidencia de biocompatibilidad para dispositivos m\u00e9dicos<\/a><\/strong> <sup><a href=\"#footnote-1\" id=\"ref-1\">1<\/a><\/sup>, o si la marca CE o FDA por s\u00ed sola ya lo cubre todo.<\/p>\n<p><strong>Los proveedores de m\u00e1quinas de terapia con ondas de choque no siempre est\u00e1n legalmente obligados a entregar un \u201cinforme de seguridad cut\u00e1nea\u201d independiente, pero deben conservar y, previa solicitud, compartir pruebas de biocompatibilidad que demuestren que todos los materiales en contacto con el paciente son seguros para la exposici\u00f3n cut\u00e1nea repetida.<\/strong><\/p>\n<p>Si lo considera como una simple compra de un dispositivo cosm\u00e9tico, puede pasar por alto f\u00e1cilmente los graves riesgos normativos y de responsabilidad civil relacionados con la seguridad del contacto con la piel.<\/p>\n<hr \/>\n<h2>\u00bfQu\u00e9 tipos de pruebas de compatibilidad con la piel son comunes en la industria?<\/h2>\n<p>Gracias a nuestra colaboraci\u00f3n con laboratorios de pruebas y consultores normativos, hemos observado que muchos compradores subestiman lo estructuradas y estandarizadas que son realmente las pruebas de compatibilidad con la piel para las piezas de mano y los accesorios de ondas de choque.<\/p>\n<p><strong>Las pruebas de compatibilidad cut\u00e1nea m\u00e1s comunes siguen la serie ISO 10993 e incluyen citotoxicidad, irritaci\u00f3n, sensibilizaci\u00f3n y, en ocasiones, caracterizaci\u00f3n de materiales, lo que conforma un paquete de biocompatibilidad que demuestra que la pieza de mano y los accesorios son seguros para el contacto con la piel intacta.<\/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=\"Laboratorio que realiza pruebas de biocompatibilidad ISO con bandejas de material etiquetadas (ID#2)\" title=\"Pruebas de laboratorio\" \/><\/p>\n<p>En el caso de los dispositivos externos, como las m\u00e1quinas de terapia con ondas de choque, la principal preocupaci\u00f3n es c\u00f3mo se comportan los materiales durante el contacto repetido con la piel intacta a lo largo del tiempo, que es precisamente el tema central de <strong><a href=\"https:\/\/www.fda.gov\/media\/142959\/download\">Norma ISO 10993-1 sobre biocompatibilidad<\/a><\/strong> <sup><a href=\"#footnote-2\" id=\"ref-2\">2<\/a><\/sup>. Incluso si la energ\u00eda se transmite a trav\u00e9s del aire o un gel, la carcasa de la pieza de mano, las tapas y las superficies de acoplamiento son importantes.<\/p>\n<h3>Bater\u00eda de pruebas t\u00edpica seg\u00fan la norma ISO 10993 para piel intacta.<\/h3>\n<p>Los reguladores esperan que los fabricantes sigan un enfoque basado en el riesgo, guiado por <strong><a href=\"https:\/\/www.fda.gov\/medical-devices\/biocompatibility-assessment-resource-center\/biocompatibility-evaluation-endpoints-device-category\">Criterios de valoraci\u00f3n de la biocompatibilidad por categor\u00eda de dispositivo<\/a><\/strong> <sup><a href=\"#footnote-3\" id=\"ref-3\">3<\/a><\/sup>, pero muchos dispositivos utilizan un conjunto m\u00ednimo est\u00e1ndar de pruebas, resumidas en <strong><a href=\"https:\/\/www.emergobyul.com\/sites\/default\/files\/2023-08\/PLC23CS1070961-ISO-Biocompatibility-Whitepaper_Final-Digital.pdf\">res\u00famenes de la serie ISO 10993 sobre biocompatibilidad<\/a><\/strong> <sup><a href=\"#footnote-10\" id=\"ref-10\">10<\/a><\/sup>:<\/p>\n<ul>\n<li><strong>Citotoxicidad<\/strong> \u2013 comprueba si los materiales son t\u00f3xicos para las c\u00e9lulas  <\/li>\n<li><strong>Irritaci\u00f3n<\/strong> \u2013 eval\u00faa si el contacto provoca enrojecimiento o inflamaci\u00f3n  <\/li>\n<li><strong>Sensibilizaci\u00f3n<\/strong> \u2013 eval\u00faa el riesgo de reacciones al\u00e9rgicas  <\/li>\n<li><strong>Caracterizaci\u00f3n de materiales<\/strong> \u2013 Identifica los ingredientes y los posibles compuestos lixiviables.  <\/li>\n<li><strong>Observaciones cl\u00ednicas o de usabilidad<\/strong> \u2013 Controla las reacciones cut\u00e1neas locales durante su uso.<\/li>\n<\/ul>\n<p>En conjunto, estos elementos proporcionan una imagen clara de si las piezas en contacto con el paciente son seguras.<\/p>\n<h3>Resumen de los m\u00e9todos de prueba m\u00e1s comunes<\/h3>\n<table>\n<thead>\n<tr>\n<th>Tipo de prueba<\/th>\n<th>Objetivo<\/th>\n<th>T\u00edpico para dispositivos Shockwave<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>Citotoxicidad<\/td>\n<td>Detecta la toxicidad celular.<\/td>\n<td>S\u00ed, est\u00e1ndar.<\/td>\n<\/tr>\n<tr>\n<td>Irritaci\u00f3n<\/td>\n<td>Revisi\u00f3n de enrojecimiento\/hinchaz\u00f3n<\/td>\n<td>S\u00ed, est\u00e1ndar.<\/td>\n<\/tr>\n<tr>\n<td>Sensibilizaci\u00f3n<\/td>\n<td>Eval\u00faa el potencial alerg\u00e9nico.<\/td>\n<td>S\u00ed, muy recomendable.<\/td>\n<\/tr>\n<tr>\n<td>An\u00e1lisis de materiales<\/td>\n<td>Identifica sustancias qu\u00edmicas y lixiviables.<\/td>\n<td>A menudo incluido<\/td>\n<\/tr>\n<tr>\n<td>Seguimiento cl\u00ednico<\/td>\n<td>Observa las reacciones durante el uso real.<\/td>\n<td>A veces, dependiendo de las reclamaciones<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<hr \/>\n<h2>\u00bfC\u00f3mo pueden los compradores asegurarse de que la pieza de mano es segura para el contacto directo con la piel?<\/h2>\n<p>Seg\u00fan nuestra experiencia en el apoyo a los propietarios de marcas, los compradores m\u00e1s exitosos no se limitan a confiar en el cat\u00e1logo. Hacen preguntas inteligentes y espec\u00edficas sobre la seguridad del contacto con la piel y solicitan pruebas antes de confirmar los pedidos.<\/p>\n<p><strong>Los compradores pueden garantizar la seguridad cut\u00e1nea de las piezas de mano solicitando los datos de biocompatibilidad ISO 10993, verificando que todos los materiales en contacto con el paciente est\u00e9n documentados, revisando los comentarios cl\u00ednicos o posteriores a la comercializaci\u00f3n y confirmando que el dise\u00f1o permita un uso higi\u00e9nico sin bordes afilados, recubrimientos t\u00f3xicos o superficies antihigi\u00e9nicas.<\/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=\"Pieza de mano m\u00e9dica con trazabilidad de materiales y documentaci\u00f3n de seguridad (ID#3)\" title=\"Materiales del dispositivo\" \/><\/p>\n<p>Una pieza de mano segura no solo se basa en los informes de pruebas. Tambi\u00e9n depende de los materiales, la ergonom\u00eda y el comportamiento del dispositivo en el uso diario en salones de belleza o cl\u00ednicas, que debe reflejar los principios de <strong><a href=\"https:\/\/www.medtechdive.com\/news\/fda-final-guidance-biocompatibility-device-skin\/693649\/\">Directrices de la FDA para dispositivos que entran en contacto con la piel intacta<\/a><\/strong> <sup><a href=\"#footnote-4\" id=\"ref-4\">4<\/a><\/sup>.<\/p>\n<h3>Pasos pr\u00e1cticos para verificar la seguridad de la piel<\/h3>\n<ol>\n<li><strong>Solicitar el resumen de biocompatibilidad<\/strong>  <\/li>\n<li><strong>Confirmar documentaci\u00f3n del material<\/strong>  <\/li>\n<li><strong>Verifique el dise\u00f1o para garantizar la higiene.<\/strong>  <\/li>\n<li><strong>Revisar los comentarios y quejas de los usuarios.<\/strong>  <\/li>\n<\/ol>\n<h3>Lista de verificaci\u00f3n para la verificaci\u00f3n del comprador<\/h3>\n<table>\n<thead>\n<tr>\n<th>Paso de verificaci\u00f3n<\/th>\n<th>Qu\u00e9 preguntar al proveedor<\/th>\n<th>Lo que confirma<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>Evidencia de biocompatibilidad<\/td>\n<td>\u201c\u00bfTienes <strong><a href=\"https:\/\/tsquality.ch\/eu-mdrs-bio-compatibility-requirements-for-medical-devices-iso-10993\/\">Pruebas de contacto con la piel seg\u00fan la norma ISO 10993<\/a><\/strong>?\u201d <sup><a href=\"#footnote-5\" id=\"ref-5\">5<\/a><\/sup><\/td>\n<td>Evaluaci\u00f3n formal de la seguridad cut\u00e1nea<\/td>\n<\/tr>\n<tr>\n<td>Lista de materiales para las \u00e1reas de contacto<\/td>\n<td>\u201c\u00bfQu\u00e9 pl\u00e1sticos y metales entran en contacto con la piel?\u201d<\/td>\n<td>Transparencia en la elecci\u00f3n de materiales<\/td>\n<\/tr>\n<tr>\n<td>Gu\u00eda para la limpieza y desinfecci\u00f3n<\/td>\n<td>\u201c\u00bfC\u00f3mo debemos limpiar la pieza de mano de forma segura?\u201d<\/td>\n<td>Higiene pr\u00e1ctica y durabilidad del recubrimiento<\/td>\n<\/tr>\n<tr>\n<td>Historial de quejas<\/td>\n<td>\u201c\u00bfSe ha informado de alg\u00fan caso de irritaci\u00f3n cut\u00e1nea en el pasado?\u201d<\/td>\n<td>Rendimiento real e historial de riesgos<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<hr \/>\n<h2>\u00bfSe requieren certificaciones espec\u00edficas para los mercados est\u00e9ticos frente a los m\u00e9dicos?<\/h2>\n<p>Dado que abastecemos tanto a clientes del \u00e1mbito m\u00e9dico como del est\u00e9tico, observamos una clara diferencia entre lo que algunos compradores de productos de belleza consideran \u201csuficiente\u201d y lo que exigen las autoridades reguladoras para los dispositivos m\u00e9dicos aut\u00e9nticos.<\/p>\n<p><strong>Los mercados m\u00e9dicos suelen exigir una autorizaci\u00f3n reglamentaria completa (como la marca CE seg\u00fan el MDR o la FDA 510(k)), que incluye pruebas de biocompatibilidad, mientras que los mercados puramente est\u00e9ticos pueden aceptar solo la seguridad el\u00e9ctrica y la documentaci\u00f3n b\u00e1sica, pero basarse \u00fanicamente en est\u00e1ndares est\u00e9ticos m\u00ednimos aumenta significativamente el riesgo.<\/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=\"Carpetas apiladas de cumplimiento de CE MDR, ISO 13485 e ISO 10993 en el laboratorio (ID#4)\" title=\"Archivos de cumplimiento normativo\" \/><\/p>\n<p>En el caso de los dispositivos m\u00e9dicos, el marcado CE debe cumplir con lo siguiente: <strong><a href=\"https:\/\/decomplix.com\/medical-device-ce-marking-guide\/\">Procesos de marcado CE del Reglamento sobre dispositivos m\u00e9dicos (MDR) de la UE<\/a><\/strong> <sup><a href=\"#footnote-6\" id=\"ref-6\">6<\/a><\/sup>, y los dispositivos de la FDA pueden requerir <strong><a href=\"https:\/\/www.fda.gov\/medical-devices\/premarket-notification-510k\/special-considerations-510ks\">Notificaci\u00f3n previa a la comercializaci\u00f3n FDA 510(k)<\/a><\/strong> <sup><a href=\"#footnote-7\" id=\"ref-7\">7<\/a><\/sup>, que requieren una justificaci\u00f3n adecuada de la biocompatibilidad.<\/p>\n<h3>Comparaci\u00f3n entre expectativas m\u00e9dicas y est\u00e9ticas<\/h3>\n<table>\n<thead>\n<tr>\n<th>Tipo de mercado<\/th>\n<th>Requisitos t\u00edpicos<\/th>\n<th>Implicaciones para la seguridad de la piel<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>M\u00e9dico (MDR de la UE)<\/td>\n<td>Marca CE, <strong><a href=\"https:\/\/www.iso.org\/iso-13485-medical-devices.html\">Sistema de gesti\u00f3n de calidad ISO 13485<\/a><\/strong> <sup><a href=\"#footnote-8\" id=\"ref-8\">8<\/a><\/sup>, ISO 10993, evidencia cl\u00ednica<\/td>\n<td>Estricto control de la biocompatibilidad<\/td>\n<\/tr>\n<tr>\n<td>M\u00e9dico (FDA de EE. UU.)<\/td>\n<td>510(k), <strong><a href=\"https:\/\/www.fda.gov\/medical-devices\/biocompatibility-assessment-resource-center\/biocompatibility-evaluation-endpoints-device-category\">Gu\u00eda de biocompatibilidad de la FDA<\/a><\/strong> <sup><a href=\"#footnote-3\" id=\"ref-3\">3<\/a><\/sup><\/td>\n<td>Pruebas cut\u00e1neas previstas para las piezas de contacto.<\/td>\n<\/tr>\n<tr>\n<td>Est\u00e9tica (uso profesional)<\/td>\n<td>Seguridad el\u00e9ctrica, compatibilidad electromagn\u00e9tica (EMC)<\/td>\n<td>Biocompatibilidad, a menudo solicitada por los compradores.<\/td>\n<\/tr>\n<tr>\n<td>Est\u00e9tica (hogar)<\/td>\n<td>Normas m\u00ednimas<\/td>\n<td>Mayor riesgo si faltan datos sobre la seguridad cut\u00e1nea.<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<hr \/>\n<h2>\u00bfQu\u00e9 riesgos conlleva la falta de datos sobre la seguridad cut\u00e1nea?<\/h2>\n<p>A partir de las conversaciones con las f\u00e1bricas y los organismos reguladores, hemos observado que escatimar en la documentaci\u00f3n sobre la seguridad cut\u00e1nea es una de las formas m\u00e1s r\u00e1pidas de que las marcas se metan en serios problemas, tanto cl\u00ednicos como legales.<\/p>\n<p><strong>La falta de datos sobre la seguridad cut\u00e1nea aumenta el riesgo de irritaci\u00f3n de los pacientes, reacciones al\u00e9rgicas, retiradas de productos, responsabilidad legal, denegaci\u00f3n de importaciones y da\u00f1os a largo plazo a la reputaci\u00f3n de la marca.<\/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=\"Documentos de evaluaci\u00f3n de la biocompatibilidad y la seguridad cut\u00e1nea de una pieza de mano m\u00e9dica (ID#5)\" title=\"Pruebas de seguridad\" \/><\/p>\n<p>El riesgo tambi\u00e9n aumenta cuando los fabricantes ignoran las expectativas cambiantes, como las <strong><a href=\"https:\/\/www.hoganlovells.com\/en\/publications\/update-to-biocompatibility-policy-for-medical-devices-in-contact-with-intact-skin\">Actualizaci\u00f3n de la pol\u00edtica de biocompatibilidad para dispositivos en contacto con la piel.<\/a><\/strong> <sup><a href=\"#footnote-9\" id=\"ref-9\">9<\/a><\/sup>, que aclara cu\u00e1ndo es aceptable la justificaci\u00f3n frente a la comprobaci\u00f3n.<\/p>\n<h3>Tabla resumen de riesgos<\/h3>\n<table>\n<thead>\n<tr>\n<th>Categor\u00eda de riesgo<\/th>\n<th>Ejemplo Consecuencia<\/th>\n<th>Nivel de impacto<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>Cl\u00ednico<\/td>\n<td>Irritaci\u00f3n, alergia, da\u00f1o cut\u00e1neo local.<\/td>\n<td>Alto<\/td>\n<\/tr>\n<tr>\n<td>Normativo<\/td>\n<td>Rechazo de importaci\u00f3n, suspensi\u00f3n de ventas<\/td>\n<td>Alto<\/td>\n<\/tr>\n<tr>\n<td>Financiero<\/td>\n<td>Devoluciones, reclamaciones de garant\u00eda, retiradas de productos<\/td>\n<td>Medio-alto<\/td>\n<\/tr>\n<tr>\n<td>Reputacional<\/td>\n<td>P\u00e9rdida de confianza con las cl\u00ednicas y los pacientes.<\/td>\n<td>Alto<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<hr \/>\n<h2>Conclusi\u00f3n<\/h2>\n<p>Al adquirir una m\u00e1quina de terapia con ondas de choque, los compradores deben considerar esencial la evidencia de seguridad para la piel, solicitar documentaci\u00f3n de biocompatibilidad basada en la norma ISO 10993 y comprender que la falta de dichos datos los expone a riesgos cl\u00ednicos, normativos y de reputaci\u00f3n tanto en el mercado m\u00e9dico como en el est\u00e9tico.<\/p>\n<hr \/>\n<h2>Notas al pie<\/h2>\n<p><span id=\"footnote-1\">1. Resumen de los conceptos de biocompatibilidad de los dispositivos m\u00e9dicos en contacto con la piel. <a href=\"#ref-1\">\u21a9\ufe0e<\/a><\/span><br \/>\n<span id=\"footnote-2\">2. Documento de orientaci\u00f3n sobre biocompatibilidad ISO 10993-1 publicado por la FDA. <a href=\"#ref-2\">\u21a9\ufe0e<\/a><\/span><br \/>\n<span id=\"footnote-3\">3. Matriz de criterios de valoraci\u00f3n de biocompatibilidad de la FDA por categor\u00eda de dispositivo. <a href=\"#ref-3\">\u21a9\ufe0e<\/a><\/span><br \/>\n<span id=\"footnote-4\">4. Resumen de noticias sobre la gu\u00eda de la FDA sobre biocompatibilidad en contacto con la piel. <a href=\"#ref-4\">\u21a9\ufe0e<\/a><\/span><br \/>\n<span id=\"footnote-5\">5. Art\u00edculo sobre los requisitos de biocompatibilidad del Reglamento sobre dispositivos m\u00e9dicos (MDR) de la UE y la norma ISO 10993. <a href=\"#ref-5\">\u21a9\ufe0e<\/a><\/span><br \/>\n<span id=\"footnote-6\">6. Gu\u00eda pr\u00e1ctica sobre el marcado CE seg\u00fan el Reglamento sobre dispositivos m\u00e9dicos (MDR) de la UE. <a href=\"#ref-6\">\u21a9\ufe0e<\/a><\/span><br \/>\n<span id=\"footnote-7\">7. P\u00e1gina de la FDA en la que se describen las consideraciones especiales sobre biocompatibilidad del 510(k). <a href=\"#ref-7\">\u21a9\ufe0e<\/a><\/span><br \/>\n<span id=\"footnote-8\">8. Resumen de la norma ISO 13485 sobre sistemas de gesti\u00f3n de calidad para dispositivos m\u00e9dicos. <a href=\"#ref-8\">\u21a9\ufe0e<\/a><\/span><br \/>\n<span id=\"footnote-9\">9. An\u00e1lisis jur\u00eddico de la pol\u00edtica actualizada de biocompatibilidad para dispositivos de piel intacta. <a href=\"#ref-9\">\u21a9\ufe0e<\/a><\/span><br \/>\n<span id=\"footnote-10\">10. Documento t\u00e9cnico que explica la serie de normas ISO 10993 sobre biocompatibilidad y la planificaci\u00f3n de ensayos. <a href=\"#ref-10\">\u21a9\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\/es\/al-adquirir-una-maquina-de-terapia-de-ondas-de-choque-el-proveedor-esta-obligado-a-proporcionar-informes-de-pruebas-de-seguridad-cutanea\/\" \/>\n<meta property=\"og:locale\" content=\"es_MX\" \/>\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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