{"id":541141,"date":"2024-11-05T16:50:14","date_gmt":"2024-11-05T16:50:14","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/din-en-iso-10993-18\/"},"modified":"2024-11-05T16:50:14","modified_gmt":"2024-11-05T16:50:14","slug":"din-en-iso-10993-18","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/din\/din-en-iso-10993-18\/","title":{"rendered":"DIN EN ISO 10993-18"},"content":{"rendered":"<p>This document specifies a framework for the identification of biological hazards and the estimation and control of biological risks from material constituents, using a stepwise approach to the characterization of a medical device through: &#8211; the identification of its materials of construction (medical device configuration); &#8211; the characterization of the materials of construction via the identification and quantification of their chemical constituents (material composition); &#8211; the characterization of the medical device for chemical substances that were introduced during manufacturing (e. g., mould release agents, process contaminants); &#8211; the estimation of the potential of the medical device, or its materials of construction, to release chemical substances under clinical use conditions (extractables); &#8211; the measurement of chemical substances released from a medical device under its clinical conditions of use (leachables). This document may also be used for chemical characterization (e. g., the identification and\/or quantification) of degradation products.<\/p>\n","protected":false},"excerpt":{"rendered":"<p><b>Biological evaluation of medical devices &#8211; Part 18: Chemical characterization of medical device materials 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\/din\/\"><b>DIN<\/b><\/a><\/td>\n<td>2021-03<\/td>\n<td>83<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":541154,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[162,2635],"product_tag":[],"class_list":{"0":"post-541141","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-11-100-20","7":"product_cat-din","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\/541141","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\/541154"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=541141"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=541141"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=541141"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}