{"id":407,"date":"2021-06-15T13:02:41","date_gmt":"2021-06-15T13:02:41","guid":{"rendered":"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/?page_id=407"},"modified":"2021-06-15T13:25:17","modified_gmt":"2021-06-15T13:25:17","slug":"iso-iec","status":"publish","type":"page","link":"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/policy\/international-standardization\/standards-development-organizations-committees-and-standards-for-medical-technology\/iso-iec\/","title":{"rendered":"ISO\/IEC"},"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-8759b15e\"><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-cbd733a0\"><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=\"177\" height=\"130\" src=\"http:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/wp-content\/uploads\/sites\/4\/2021\/06\/ISO-IEC.jpg\" alt=\"\" class=\"wp-image-441\"\/><\/figure><\/div>\n<\/div><\/div>\n\n\n\n<div class=\"wp-block-uagb-column uagb-column__wrap uagb-column__background-undefined uagb-block-e15c30bc\"><div class=\"uagb-column__overlay\"><\/div><div class=\"uagb-column__inner-wrap\">\n<p><strong>The IMDRF Essential Principles&nbsp;<\/strong>reference&nbsp;dozens of standards from ISO and IEC as well as from other international standards organizations:<\/p>\n\n\n\n<p>The table below lists the primary ISO and IEC committees responsible for the development of standards that can be used by medical device manufacturers to demonstrate compliance of medical devices with the essential requirements of safety and performance, according to ISO 16142-1 and ISO 16142-2.<\/p>\n<\/div><\/div>\n<\/div><\/section>\n\n\n\n<h2 class=\"has-medium-font-size wp-block-heading\"><strong>ISO Technical Committees<\/strong>&nbsp;<strong>and Subcommittees<\/strong><\/h2>\n\n\n\n<figure class=\"wp-block-image size-large\"><img loading=\"lazy\" decoding=\"async\" width=\"597\" height=\"544\" src=\"http:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/wp-content\/uploads\/sites\/4\/2021\/06\/ISO-Technical-Committees.png\" alt=\"\" class=\"wp-image-452\" srcset=\"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/wp-content\/uploads\/sites\/4\/2021\/06\/ISO-Technical-Committees.png 597w, https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/wp-content\/uploads\/sites\/4\/2021\/06\/ISO-Technical-Committees-300x273.png 300w\" sizes=\"auto, (max-width: 597px) 100vw, 597px\" \/><\/figure>\n\n\n\n<h2 class=\"has-medium-font-size wp-block-heading\"><strong><strong>IEC Technical Committees<\/strong>&nbsp;<strong>and Subcommittees<\/strong><\/strong><\/h2>\n\n\n\n<figure class=\"wp-block-image size-large\"><img loading=\"lazy\" decoding=\"async\" width=\"671\" height=\"256\" src=\"http:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/wp-content\/uploads\/sites\/4\/2021\/06\/IEC-Technical-Committees.png\" alt=\"\" class=\"wp-image-450\" srcset=\"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/wp-content\/uploads\/sites\/4\/2021\/06\/IEC-Technical-Committees.png 671w, https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/wp-content\/uploads\/sites\/4\/2021\/06\/IEC-Technical-Committees-300x114.png 300w\" sizes=\"auto, (max-width: 671px) 100vw, 671px\" \/><\/figure>\n\n\n\n<p>List of ISO\/IEC Member Bodies and Participation in Medical Device Committees available in this&nbsp;<a href=\"http:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/wp-content\/uploads\/sites\/4\/2021\/06\/SDOs-MDs-ISOIEC.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">link<\/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 .wpcp-fancybox-nav-arrow i {color: #ccc;}.sp-wp-carousel-free-id-118.wpcf-fancybox-wrapper .fancybox-navigation .fancybox-button .wpcp-fancybox-nav-arrow i:hover {color: #fff;}.sp-wp-carousel-free-id-118.wpcf-fancybox-wrapper .fancybox-navigation .fancybox-button {background: #1e1e1e;}.sp-wp-carousel-free-id-118.wpcf-fancybox-wrapper .fancybox-navigation .fancybox-button:hover {background: #1e1e1e;}#sp-wp-carousel-free-id-118 .wpcp-swiper-dots {margin: 40px 0px 0px 0px;}.wpcp-wrapper-118 .swiper-wrapper .swiper-slide-kenburn, .wpcp-wrapper-118 .swiper-wrapper, .wpcp-wrapper-118 .wpcpro-row{align-items: center;}#sp-wp-carousel-free-id-118 .wpcp-single-item {box-shadow: 0px 0px 0px 0px #dddddd;transition: all .3s;margin: 0px;}#sp-wp-carousel-free-id-118.swiper-flip .wpcp-single-item{margin: 0!important;}#sp-wp-carousel-free-id-118 .wpcp-single-item:hover {box-shadow: 0px 0px 0px 0px #dddddd;}#sp-wp-carousel-free-id-118.sp-wpcp-118 .wpcp-single-item {border: 0px solid transparent;}#sp-wp-carousel-free-id-118.sp-wpcp-118 .swiper-button-prev,#sp-wp-carousel-free-id-118.sp-wpcp-118 .swiper-button-next,#sp-wp-carousel-free-id-118.sp-wpcp-118 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class=\"skip-lazy\" src=\"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/wp-content\/uploads\/sites\/4\/2021\/06\/member_aldimed.jpg\" alt=\"member_aldimed\" width=\"240\" height=\"39\">\t<\/div>\n\t\t<\/div>\n<\/div>\n\t<div class=\"swiper-slide\">\n\t<div class=\"wpcp-single-item\">\n\t\t\t<div class=\"wpcp-slide-image\">\n\t\t<img loading=\"lazy\" decoding=\"async\" class=\"skip-lazy\" src=\"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/wp-content\/uploads\/sites\/4\/2021\/06\/member_amid.jpg\" alt=\"member_amid\" width=\"240\" height=\"98\">\t<\/div>\n\t\t<\/div>\n<\/div>\n\t<div class=\"swiper-slide\">\n\t<div class=\"wpcp-single-item\">\n\t\t\t<div class=\"wpcp-slide-image\">\n\t\t<img loading=\"lazy\" decoding=\"async\" class=\"skip-lazy\" src=\"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/wp-content\/uploads\/sites\/4\/2021\/06\/member_advamed.jpg\" alt=\"member_advamed\" width=\"240\" 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and&hellip;<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":195,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"_uag_custom_page_level_css":"","footnotes":""},"class_list":["post-407","page","type-page","status-publish","hentry","description-off"],"acf":[],"featured_image_src":null,"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>ISO\/IEC - Regulatory Convergence<\/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:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/policy\/international-standardization\/standards-development-organizations-committees-and-standards-for-medical-technology\/iso-iec\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" 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