{"id":197976,"date":"2024-10-19T12:36:17","date_gmt":"2024-10-19T12:36:17","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/aami-tir37137-2014\/"},"modified":"2024-10-25T05:09:33","modified_gmt":"2024-10-25T05:09:33","slug":"aami-tir37137-2014","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/aami\/aami-tir37137-2014\/","title":{"rendered":"AAMI TIR37137 2014"},"content":{"rendered":"

Provides interim part-by-part guidance on potential adjustments to various test methods within the 10993 series to account for the intentional release of soluble components or degradation products from absorbable medical devices.<\/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\n\n\n\n\n
PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
1<\/td>\nANSI\/AAMI\/ISO TIR37137:2014, Cardiovascular biological evaluation of medical devices \u2014 Guidance for absorbable implants <\/td>\n<\/tr>\n
3<\/td>\nTitle report <\/td>\n<\/tr>\n
4<\/td>\nCopyright information <\/td>\n<\/tr>\n
5<\/td>\nAAMI Technical Information Report
ANSI Technical Report <\/td>\n<\/tr>\n
6<\/td>\nContents <\/td>\n<\/tr>\n
7<\/td>\nGlossary of equivalent standards <\/td>\n<\/tr>\n
8<\/td>\nCommittee representation <\/td>\n<\/tr>\n
10<\/td>\nBackground of AAMI adoption of ISO\/TR 37137:2014 <\/td>\n<\/tr>\n
11<\/td>\nForeword <\/td>\n<\/tr>\n
13<\/td>\n1 Scope
2 Terms and definitions
3 General considerations <\/td>\n<\/tr>\n
14<\/td>\n4 Sterilization considerations <\/td>\n<\/tr>\n
15<\/td>\n5 Drug-device combination product considerations
6 Part listing and description of absorbable related issues in addition to the relevant parts of ISO 10993 series \u201cBiological evaluation of medical devices\u201d
6.1 ISO 10993-1:2009, Evaluation and testing within a risk management process <\/td>\n<\/tr>\n
16<\/td>\n6.2 ISO 10993-2:2006, Animal welfare requirements
6.3 ISO 10993-3:2003, Tests for genotoxicity, carcinogenicity and reproductive toxicity
6.4 ISO 10993-4:2002, Selection of tests for interactions with blood <\/td>\n<\/tr>\n
17<\/td>\n6.5 ISO 10993-5:2009, Tests for in vitro cytotoxicity <\/td>\n<\/tr>\n
18<\/td>\n6.6 ISO 10993-6:2007, Tests for local effects after implantation <\/td>\n<\/tr>\n
19<\/td>\n6.7 ISO 10993-7:2008, Ethylene oxide sterilization residuals <\/td>\n<\/tr>\n
20<\/td>\n6.8 ISO 10993-9:2009, Framework for identification and quantification of potential degradation products
6.9 ISO 10993-10:2010, Tests for irritation and delayed-type hypersensitivity
6.10 ISO 10993-11:2006, Biological evaluation of medical devices \u2014 Part 11: Tests for systemic toxicity <\/td>\n<\/tr>\n
21<\/td>\n6.11 ISO 10993-12:2012, Sample preparation and reference materials <\/td>\n<\/tr>\n
24<\/td>\n6.12 ISO 10993-13:2010, Identification and quantification of degradation products from polymeric medical devices
6.13 ISO 10993-14:2001, Identification and quantification of degradation products from ceramics
6.14 ISO 10993-15:2000, Identification and quantification of degradation products from metals and alloys
6.15 ISO 10993-16:2010, Toxicokinetic study design for degradation products and leachables
6.16 ISO 10993-17:2002, Establishment of allowable limits for leachable substances
6.17 ISO 10993-18:2005, Chemical characterization of materials <\/td>\n<\/tr>\n
25<\/td>\n6.18 ISO\/TS 10993-19:2006, Physico-chemical, morphological and topographical characterization of materials
6.19 ISO\/TS 10993-20:2006, Principles and methods for immunotoxicology testing of medical devices <\/td>\n<\/tr>\n
26<\/td>\nAnnex A: Nomenclature of absorb, degrade and related terms0F <\/td>\n<\/tr>\n
27<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

ANSI\/AAMI\/ISO TIR37137:2014 – Cardiovascular biological evaluation of medical devices-Guidance for absorbable implants<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
AAMI<\/b><\/a><\/td>\n2014<\/td>\n27<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":197979,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2654],"product_tag":[],"class_list":{"0":"post-197976","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\/197976","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\/197979"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=197976"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=197976"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=197976"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}