{"id":578698,"date":"2024-11-05T20:08:37","date_gmt":"2024-11-05T20:08:37","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/iec-tr-80002-32014\/"},"modified":"2024-11-05T20:08:37","modified_gmt":"2024-11-05T20:08:37","slug":"iec-tr-80002-32014","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/iec\/iec-tr-80002-32014\/","title":{"rendered":"IEC TR 80002-3:2014"},"content":{"rendered":"<p>IEC TR 80002-3:2014 which is a technical report (TR), provides the description of software life cycle processes for medical devices. The medical device software life cycle processes are derived from IEC 62304:2006, with corresponding safety classes. They have been aligned with the software development life cycle processes of ISO\/IEC 12207:2008 and are presented herein in full compliance with ISO\/IEC 24774:2010. The content of these three standards provides the foundation of this TR. This TR does not:<br \/>\n&#8211; address areas already covered by existing related standards, e.g. the international standards that relate to the four standards used to build this TR (see Bibliography);<br \/>\n&#8211; FDA guidance documents; or<br \/>\n&#8211; software development tools. This TR describes the process reference model for medical device software development and is limited in scope to the life cycle processes described in IEC 62304:2006. The process names correspond to those of IEC 62304:2006. The mappings provided in Annex B are essential for the alignment between IEC 62304:2006 (which is based on ISO\/IEC 12207:1995) and ISO\/IEC 12207:2008, developed to address the detailed normative relationship between the two standards. This technical report is not intended to be used as the basis of regulatory inspection or certification assessment activities.<\/p>\n","protected":false},"excerpt":{"rendered":"<p><b>Medical device software &#8211; Part 3: Process reference model of medical device software life cycle processes (IEC 62304)<\/b><\/p>\n<table style=\"width: 100%\" border=\"0\" cellspacing=\"0\" cellpadding=\"0\">\n<tbody>\n<tr>\n<td>Published By<\/td>\n<td>Publication Date<\/td>\n<td>Number of Pages<\/td>\n<\/tr>\n<tr>\n<td><a href=\"https:\/\/pdfstandards.shop\/product-category\/publishers\/iec\/\"><b>IEC<\/b><\/a><\/td>\n<td>2014-06-04<\/td>\n<td>32<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":578710,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[136,2636],"product_tag":[],"class_list":{"0":"post-578698","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-11-040-01","7":"product_cat-iec","9":"first","10":"instock","11":"sold-individually","12":"shipping-taxable","13":"purchasable","14":"product-type-simple"},"_links":{"self":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product\/578698","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product"}],"about":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/types\/product"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media\/578710"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=578698"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=578698"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=578698"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}