{"id":453392,"date":"2024-10-20T09:30:00","date_gmt":"2024-10-20T09:30:00","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/aami-tir10993-19-2020\/"},"modified":"2024-10-26T17:37:34","modified_gmt":"2024-10-26T17:37:34","slug":"aami-tir10993-19-2020","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/aami\/aami-tir10993-19-2020\/","title":{"rendered":"AAMI TIR10993 19 2020"},"content":{"rendered":"

This document provides a compilation of parameters and test methods that can be useful for the identification and evaluation of the physical, i.e. physico?chemical, morphological and topographical (PMT) properties of materials in finished medical devices. Such an assessment is limited to those properties that are relevant to biological evaluation and the medical device’s intended use (clinical application and duration of use) even if such properties overlap with clinical effectiveness.<\/p>\n

PDF Catalog<\/h4>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
1<\/td>\nAAMI\/ISO TIR10993-19:2020; Biological evaluation of medical devices\u2014Part 19: Physico-chemical, morphological and topographical characterization of materials <\/td>\n<\/tr>\n
3<\/td>\nTitle page <\/td>\n<\/tr>\n
5<\/td>\nCopyright information
AAMI Technical Information Report <\/td>\n<\/tr>\n
6<\/td>\nANSI Registration
Contents <\/td>\n<\/tr>\n
7<\/td>\nCommittee representation <\/td>\n<\/tr>\n
9<\/td>\nBackground of AAMI adoption of ISO\/TS 10993-19:2020 <\/td>\n<\/tr>\n
10<\/td>\nForeword <\/td>\n<\/tr>\n
11<\/td>\nIntroduction <\/td>\n<\/tr>\n
13<\/td>\n1 Scope
2 Normative references
3 Terms and definitions <\/td>\n<\/tr>\n
14<\/td>\n4 General principles <\/td>\n<\/tr>\n
15<\/td>\n5 Characterization procedure
5.1 General
5.2 Qualitative information
5.3 Material equivalence <\/td>\n<\/tr>\n
16<\/td>\n5.4 Quantitative Assessment
6 Characterization parameters and methods <\/td>\n<\/tr>\n
17<\/td>\nTable 1 \u2014 Typical properties assessed for PMT characterization of materials including polymers, metals, alloys, ceramics and natural macromolecules
Table 2 \u2014 Other properties to consider assessing for PMT characterization, depending on material composition
7 Reporting of data obtained <\/td>\n<\/tr>\n
18<\/td>\nAnnex A (informative) Principles for judging material equivalence <\/td>\n<\/tr>\n
19<\/td>\nTable A.1 \u2014 Methodology abbreviations
Table A.2 \u2014 Typical properties assessed for PMT characterization and potential methods and references <\/td>\n<\/tr>\n
21<\/td>\nTable A.3 \u2014 Other properties to consider assessing for PMT characterization and potential methods and references <\/td>\n<\/tr>\n
23<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

AAMI\/ISO TIR10993-19:2020 Biological evaluation of medical devices\u2014Part 19: Physico-chemical, morphological and topographical characterization of materials<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
AAMI<\/b><\/a><\/td>\n2020<\/td>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":453399,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2654],"product_tag":[],"class_list":{"0":"post-453392","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-aami","8":"first","9":"instock","10":"sold-individually","11":"shipping-taxable","12":"purchasable","13":"product-type-simple"},"_links":{"self":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product\/453392","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\/453399"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=453392"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=453392"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=453392"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}