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
the identification of its materials of construction (medical device configuration);<\/p>\n<\/li>\n
the characterization of the materials of construction via the identification and quantification of their chemical constituents (material composition);<\/p>\n<\/li>\n
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<\/li>\n
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<\/li>\n
the measurement of chemical substances released from a medical device under its clinical conditions of use (leachables).<\/p>\n<\/li>\n<\/ul>\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<\/span><\/span>, ISO 10993-13<\/span><\/span>, ISO 10993-14<\/span><\/span> and ISO 10993-15<\/span><\/span>.<\/p>\n The ISO 10993 series<\/span><\/span> is applicable when the material or medical device has direct or indirect body contact (see ISO 10993-1<\/span><\/span> 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 Biological evaluation of medical devices – Chemical characterization of medical device materials within a risk management process<\/b><\/p>\nPDF Catalog<\/h4>\n
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\n PDF Pages<\/th>\n PDF Title<\/th>\n<\/tr>\n \n 2<\/td>\n undefined <\/td>\n<\/tr>\n \n 6<\/td>\n Annex ZA (informative)Relationship between this European standard and the General Safety and Performance Requirements of Regulation (EU) 2017\/745 aimed to be covered <\/td>\n<\/tr>\n \n 8<\/td>\n Annex ZB (informative)Relationship between this European Standard and the essential requirements of Directive 90\/385\/EEC [OJ L 189] aimed to be covered <\/td>\n<\/tr>\n \n 10<\/td>\n Annex ZC (informative)Relationship between this European standard and the General Safety and Performance Requirements of Regulation (EU) 2017\/745 aimed to be covered <\/td>\n<\/tr>\n \n 13<\/td>\n Foreword <\/td>\n<\/tr>\n \n 14<\/td>\n Introduction <\/td>\n<\/tr>\n \n 16<\/td>\n 1 Scope
2 Normative references <\/td>\n<\/tr>\n\n 17<\/td>\n 3 Terms and definitions <\/td>\n<\/tr>\n \n 21<\/td>\n 4 Symbols and abbreviated terms <\/td>\n<\/tr>\n \n 22<\/td>\n 5 Characterization procedure
5.1 General <\/td>\n<\/tr>\n\n 25<\/td>\n 5.2 Establish medical device configuration and material composition
5.2.1 General <\/td>\n<\/tr>\n\n 26<\/td>\n 5.2.2 Information gathering
5.2.3 Information generation <\/td>\n<\/tr>\n\n 27<\/td>\n 5.3 Assess material\/chemical equivalence to a clinically established material or medical device <\/td>\n<\/tr>\n \n 28<\/td>\n 5.4 Assess the hypothetical worst-case chemical release based on total exposure to the medical device\u2019s chemical constituents
5.4.1 Establish the hypothetical worst-case chemical release
5.4.2 Assess the hypothetical worst-case chemical release <\/td>\n<\/tr>\n\n 29<\/td>\n 5.5 Establish an analytical evaluation threshold
5.6 Estimate the chemical release; perform extraction study <\/td>\n<\/tr>\n\n 32<\/td>\n 5.7 Assess the estimated chemical release (extractables profile)
5.8 Determine the actual chemical release; perform leachables study <\/td>\n<\/tr>\n\n 34<\/td>\n 5.9 Assess the actual chemical release (leachables profile)
5.10 Exiting the chemical characterization process
6 Chemical characterization parameters and methods
6.1 General <\/td>\n<\/tr>\n\n 35<\/td>\n 6.2 Material composition <\/td>\n<\/tr>\n \n 37<\/td>\n 6.3 Extractables and leachables <\/td>\n<\/tr>\n \n 39<\/td>\n 6.4 Structural composition or configuration <\/td>\n<\/tr>\n \n 40<\/td>\n 6.5 Analytical methods <\/td>\n<\/tr>\n \n 41<\/td>\n 7 Reporting of the chemical characterization data <\/td>\n<\/tr>\n \n 42<\/td>\n Annex A (informative) General principles of chemical characterization <\/td>\n<\/tr>\n \n 46<\/td>\n Annex B (informative) Information sources for chemical characterization <\/td>\n<\/tr>\n \n 50<\/td>\n Annex C (informative) Principles for establishing biological equivalence <\/td>\n<\/tr>\n \n 53<\/td>\n Annex D (informative) Principles of sample extraction <\/td>\n<\/tr>\n \n 65<\/td>\n Annex E (informative) Calculation and application of the analytical evaluation threshold (AET) <\/td>\n<\/tr>\n \n 73<\/td>\n Annex F (informative) Qualification of analytical methods used for extractables\/leachables <\/td>\n<\/tr>\n \n 76<\/td>\n Annex G (informative) Reporting details for analytical methods and chemical data <\/td>\n<\/tr>\n \n 79<\/td>\n Bibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" \n\n
\n Published By<\/td>\n Publication Date<\/td>\n Number of Pages<\/td>\n<\/tr>\n \n BSI<\/b><\/a><\/td>\n 2020<\/td>\n 84<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":279637,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[162,2641],"product_tag":[],"class_list":{"0":"post-279629","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-11-100-20","7":"product_cat-bsi","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\/279629","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\/279637"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=279629"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=279629"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=279629"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}