{"id":584490,"date":"2024-11-05T20:39:45","date_gmt":"2024-11-05T20:39:45","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/iso-10993-12009\/"},"modified":"2024-11-05T20:39:45","modified_gmt":"2024-11-05T20:39:45","slug":"iso-10993-12009","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/iso\/iso-10993-12009\/","title":{"rendered":"ISO 10993-1:2009"},"content":{"rendered":"<p>ISO 10993-1:2009 describes:<\/p>\n<ul>\n<li>the general principles governing the biological evaluation of medical devices within a risk management process;<\/li>\n<li>the general categorization of devices based on the nature and duration of their contact with the body;<\/li>\n<li>the evaluation of existing relevant data from all sources;<\/li>\n<li>the identification of gaps in the available data set on the basis of a risk analysis;<\/li>\n<li>the identification of additional data sets necessary to analyse the biological safety of the medical device;<\/li>\n<li>the assessment of the biological safety of the medical device.<\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p><b>Biological evaluation of medical devices \u2014 Part 1: Evaluation and testing within a risk management process<\/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>2009-10<\/td>\n<td>28<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":584505,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[162,2634],"product_tag":[],"class_list":{"0":"post-584490","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\/584490","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\/584505"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=584490"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=584490"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=584490"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}