{"id":1555,"date":"2021-06-17T20:13:25","date_gmt":"2021-06-17T20:13:25","guid":{"rendered":"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/politica\/normalizacion-internacional\/organizaciones-para-el-desarrollo-de-normas-comites-y-normas-para-tecnologia-medica\/astm-international\/"},"modified":"2021-06-18T14:13:54","modified_gmt":"2021-06-18T14:13:54","slug":"astm-international","status":"publish","type":"page","link":"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/policy\/international-standardization\/organismos-nacionales-de-estandarizacion-de-las-americas\/astm-international\/?lang=es","title":{"rendered":"ASTM International"},"content":{"rendered":"\n<section class=\"wp-block-uagb-columns uagb-columns__wrap uagb-columns__background-undefined uagb-columns__stack-mobile uagb-columns__valign-undefined uagb-columns__gap-0 alignundefined uagb-block-fc7b055f\"><div class=\"uagb-columns__overlay\"><\/div><div class=\"uagb-columns__inner-wrap uagb-columns__columns-2\">\n<div class=\"wp-block-uagb-column uagb-column__wrap uagb-column__background-undefined uagb-block-8d811dbf\"><div class=\"uagb-column__overlay\"><\/div><div class=\"uagb-column__inner-wrap\">\n<div class=\"wp-block-image\"><figure class=\"aligncenter size-large\"><img loading=\"lazy\" decoding=\"async\" width=\"199\" height=\"149\" src=\"http:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/wp-content\/uploads\/sites\/4\/2021\/06\/ASTM-Logo.png\" alt=\"\" class=\"wp-image-464\"\/><\/figure><\/div>\n<\/div><\/div>\n\n\n\n<div class=\"wp-block-uagb-column uagb-column__wrap uagb-column__background-undefined uagb-block-1694437b\"><div class=\"uagb-column__overlay\"><\/div><div class=\"uagb-column__inner-wrap\">\n<p>ASTM International es una organizaci\u00f3n sin fines de lucro que proporciona un foro para el desarrollo y publicaci\u00f3n de normas consensuadas voluntarias internacionales para materiales, productos, sistemas y servicios. Los miembros voluntarios representan a productores, usuarios, consumidores, al gobierno y la academia de m\u00e1s de 140 pa\u00edses.<\/p>\n\n\n\n<p>El Comit\u00e9 F04 de ASTM sobre dispositivos m\u00e9dicos y quir\u00fargicos se organiz\u00f3 en 1962 e incluye a m\u00e1s de 950 miembros de 31 pa\u00edses. Este comit\u00e9 est\u00e1 compuesto por 24 subcomit\u00e9s que abordan segmentos espec\u00edficos organizados en 4 divisiones:<\/p>\n<\/div><\/div>\n<\/div><\/section>\n\n\n\n<p class=\"mb-3\">Divisi\u00f3n I \u2013 Recursos<br>Divisi\u00f3n II \u2013 Dispositivos ortop\u00e9dicos<br>Divisi\u00f3n III \u2013 Dispositivos m\u00e9dicos\/quir\u00fargicos<br>Divisi\u00f3n IV \u2013 Productos m\u00e9dicos de ingenier\u00eda de tejidos<\/p>\n\n\n\n<p class=\"mb-3\">El Comit\u00e9 F42 de ASTM sobre tecnolog\u00edas de fabricaci\u00f3n aditiva se organiz\u00f3 en 2009 e incluye a m\u00e1s de 600 miembros de 28 pa\u00edses. Este comit\u00e9 est\u00e1 compuesto por 6 subcomit\u00e9s. Hay 23 normas activas y 15 proyectos de normas nuevas propuestas que apoyan indirectamente a la comunidad de dispositivos m\u00e9dicos para la fabricaci\u00f3n aditiva.<\/p>\n\n\n\n<h2 class=\"has-medium-font-size wp-block-heading\">Memorandum de Entendimiento \u2013 ASTM<\/h2>\n\n\n\n<p>Los MOU est\u00e1n dise\u00f1ados para fomentar la participaci\u00f3n de expertos t\u00e9cnicos de todo el mundo en el proceso de desarrollo de normas de ASTM y ampliar la aceptaci\u00f3n y el uso mundial de las normas de ASTM International.<\/p>\n\n\n\n<p class=\"mb-3\">Como beneficio del programa de MOU, los expertos t\u00e9cnicos de cualquier pa\u00eds con un MOU de ASTM pueden participar sin cargo como miembros con derecho a voto en el proceso de desarrollo de normas de ASTM. Se proporciona acceso a las normas ASTM al organismo nacional de normas.<\/p>\n\n\n\n<h2 class=\"has-medium-font-size wp-block-heading\">Los MOU de la ASTM<\/h2>\n\n\n\n<p class=\"mb-3\">ASTM International ha firmado Memoranda de Entendimiento (MOU) con pa\u00edses de Am\u00e9rica Latina y el Caribe.&nbsp;<a href=\"http:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/wp-content\/uploads\/sites\/4\/2021\/06\/SDOs-MDs-ISOIEC_ESPA\u2022OL-2.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">Haz click aqu\u00ed<\/a> para acceder a una lista de signatarios de los memoranda de entendimiento con estos pa\u00edses.<\/p>\n\n\n\n<p>M\u00e1s informaci\u00f3n:<\/p>\n\n\n\n<p><a href=\"https:\/\/www.astm.org\/\" target=\"_blank\" rel=\"noreferrer noopener\">Sitio web de ASTM<\/a><br><a href=\"https:\/\/www.astm.org\/COMMIT\/SUBCOMMIT\/F04.htm\" target=\"_blank\" rel=\"noreferrer noopener\">ASTM \u2013 Comit\u00e9s de Normas de Dispositivos M\u00e9dicos<\/a><br><a href=\"http:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/wp-content\/uploads\/sites\/4\/2021\/06\/ASTM-International-Foundational-PPT-updated.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">ASTM \u2013 Presentaci\u00f3n<\/a><br><a href=\"https:\/\/www.astm.org\/GLOBAL\/mou.html\" target=\"_blank\" rel=\"noreferrer noopener\">ASTM Programa de MOU<\/a><\/p>\n\n\n\n<section class=\"wp-block-uagb-section uagb-section__wrap uagb-section__background-undefined uagb-block-c660273d\"><div class=\"uagb-section__overlay\"><\/div><div class=\"uagb-section__inner-wrap\">\n<h3 class=\"wp-block-heading has-text-align-center mb-2 has-normal-font-size\" id=\"regulatory-coalition-principal-members\">REGULATORY COALITION PRINCIPAL MEMBERS<\/h3>\n\n\n<style id=\"wp_carousel_dynamic_css118\">.sp-wp-carousel-free-id-118.wpcf-fancybox-wrapper .fancybox-bg{background: #0b0b0b;opacity: 0.8;}.sp-wp-carousel-free-id-118.wpcf-fancybox-wrapper .fancybox-navigation .fancybox-button 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