{"id":584489,"date":"2024-11-05T20:39:45","date_gmt":"2024-11-05T20:39:45","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/iso-10993-182020\/"},"modified":"2024-11-05T20:39:45","modified_gmt":"2024-11-05T20:39:45","slug":"iso-10993-182020","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/iso\/iso-10993-182020\/","title":{"rendered":"ISO 10993-18:2020"},"content":{"rendered":"

This document specifies a framework for the identification, and if necessary, quantification of constituents of a medical device, allowing the identification of biological hazards and the estimation and control of biological risks from material constituents, using a generally stepwise approach to the chemical characterization which can include one or more of the following:<\/p>\n

\u2014 the identification of its materials of construction (medical device configuration);<\/p>\n

\u2014 the characterization of the materials of construction via the identification and quantification of their chemical constituents (material composition);<\/p>\n

\u2014 the characterization of the medical device for chemical substances that were introduced during manufacturing (e.g. mould release agents, process contaminants, sterilization residues);<\/p>\n

\u2014 the estimation (using laboratory extraction conditions) of the potential of the medical device, or its materials of construction, to release chemical substances under clinical use conditions (extractables);<\/p>\n

\u2014 the measurement of chemical substances released from a medical device under its clinical conditions of use (leachables).<\/p>\n

This document can also be used for chemical characterization (e.g. the identification and\/or quantification) of degradation products. Information on other aspects of degradation assessment are covered in ISO 10993-9, ISO 10993-13, ISO 10993-14 and ISO 10993-15.<\/p>\n

The ISO 10993 series is applicable when the material or medical device has direct or indirect body contact (see ISO 10993-1 for categorization by nature of body contact).<\/p>\n

This document is intended for suppliers of materials and manufacturers of medical devices, to support a biological evaluation.<\/p>\n","protected":false},"excerpt":{"rendered":"

Biological evaluation of medical devices \u2014 Part 18: Chemical characterization of medical device materials within a risk management process<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
ISO<\/b><\/a><\/td>\n2020-01<\/td>\n74<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":584504,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[162,2634],"product_tag":[],"class_list":{"0":"post-584489","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\/584489","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\/584504"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=584489"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=584489"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=584489"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}