{"id":599417,"date":"2024-11-05T22:01:05","date_gmt":"2024-11-05T22:01:05","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/iso-175932022\/"},"modified":"2024-11-05T22:01:05","modified_gmt":"2024-11-05T22:01:05","slug":"iso-175932022","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/iso\/iso-175932022\/","title":{"rendered":"ISO 17593:2022"},"content":{"rendered":"<p>This document specifies requirements for in vitro measuring systems for self-monitoring of vitamin-K antagonist oral anticoagulation therapy, including performance, quality assurance and user training and procedures for the validation of performance by the intended users under actual and simulated conditions of use.<\/p>\n<p>This document applies solely to prothrombin time measuring systems used by lay persons for monitoring their own vitamin-K antagonist oral anticoagulation therapy, and which report results as international normalized ratios (INR).<\/p>\n<p>This document is applicable to manufacturers of such systems and those other organizations (e.g. regulatory authorities and conformity assessment bodies) having the responsibility for assessing the performance of these systems.<\/p>\n<p>This document is not applicable to:<\/p>\n<p>\u2014\u00a0\u00a0\u00a0 in vitro measuring systems for coagulation quantities assessing vitamin-K antagonist oral anticoagulation therapy used by physicians or healthcare providers;<\/p>\n<p>\u2014\u00a0\u00a0\u00a0 non-vitamin-K antagonist oral anticoagulation therapy (e.g. dabigatran);<\/p>\n<p>\u2014\u00a0\u00a0\u00a0 a comprehensive evaluation of all possible factors that can affect the performance of these systems;<\/p>\n<p>\u2014\u00a0\u00a0\u00a0 the medical aspects of oral-anticoagulation therapy.<\/p>\n","protected":false},"excerpt":{"rendered":"<p><b>Clinical laboratory testing and in vitro medical devices &#8211; Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy<\/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\/iso\/\"><b>ISO<\/b><\/a><\/td>\n<td>2022-03<\/td>\n<td>60<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":599429,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[162,2634],"product_tag":[],"class_list":{"0":"post-599417","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-11-100-20","7":"product_cat-iso","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\/599417","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\/599429"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=599417"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=599417"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=599417"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}