{"id":576850,"date":"2024-11-05T19:58:13","date_gmt":"2024-11-05T19:58:13","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/iec-80001-12021\/"},"modified":"2024-11-05T19:58:13","modified_gmt":"2024-11-05T19:58:13","slug":"iec-80001-12021","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/iec\/iec-80001-12021\/","title":{"rendered":"IEC 80001-1:2021"},"content":{"rendered":"<p>IEC 80001-1:2021 specifies general requirements for ORGANIZATIONS in the application of RISK MANAGEMENT before, during and after the connection of a HEALTH IT SYSTEM within a HEALTH IT INFRASTRUCTURE, by addressing the KEY PROPERTIES of SAFETY, EFFECTIVENESS and SECURITY whilst engaging appropriate stakeholders.<br \/>\nIEC 80001-1:2021 cancels and replaces the first edition published in 2010. This edition constitutes a technical revision.<br \/>\nThis edition includes the following significant technical changes with respect to the previous edition:<br \/>\na) structure changed to better align with ISO 31000;<br \/>\nb) establishment of requirements for an ORGANIZATION in the application of RISK MANAGEMENT;<br \/>\nc) communication of the value, intention and purpose of RISK MANAGEMENT through principles that support preservation of the KEY PROPERTIES during the implementation and use of connected HEALTH SOFTWARE and\/or HEALTH IT SYSTEMS.<\/p>\n","protected":false},"excerpt":{"rendered":"<p><b>Application of risk management for IT-networks incorporating medical devices &#8211; Part 1: Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software<\/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>2021-09-21<\/td>\n<td>80<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":576866,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[136,704,2636],"product_tag":[],"class_list":{"0":"post-576850","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-11-040-01","7":"product_cat-35-240-80","8":"product_cat-iec","10":"first","11":"instock","12":"sold-individually","13":"shipping-taxable","14":"purchasable","15":"product-type-simple"},"_links":{"self":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product\/576850","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\/576866"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=576850"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=576850"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=576850"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}