{"id":371896,"date":"2024-10-20T02:26:49","date_gmt":"2024-10-20T02:26:49","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bsi-pd-iso-ts-37137-12021\/"},"modified":"2024-10-26T04:15:34","modified_gmt":"2024-10-26T04:15:34","slug":"bsi-pd-iso-ts-37137-12021","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bsi-pd-iso-ts-37137-12021\/","title":{"rendered":"BSI PD ISO\/TS 37137-1:2021"},"content":{"rendered":"

This document specifies the requirements for the evaluation of absorbable medical devices during a biological risk assessment based on ISO 10993-1<\/span><\/span>, including a clarification of the terms “absorb”, “degrade” and other related terms (see Annex A<\/span>).<\/p>\n

PDF Catalog<\/h4>\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
2<\/td>\nNational foreword <\/td>\n<\/tr>\n
6<\/td>\nForeword <\/td>\n<\/tr>\n
7<\/td>\nIntroduction <\/td>\n<\/tr>\n
9<\/td>\n1 Scope
2 Normative references
3 Terms and definitions <\/td>\n<\/tr>\n
10<\/td>\n4 General considerations <\/td>\n<\/tr>\n
12<\/td>\n5 Test article considerations
6 Sterilization considerations
7 Drug-device combination product considerations
8 \u200bEvaluation of absorbable medical devices in the context of the ISO 10993 series
8.1 General <\/td>\n<\/tr>\n
13<\/td>\n8.2 \u200bISO 10993\u20111, evaluation and testing within a risk management process
8.3 \u200bISO 10993\u20112, animal welfare requirements
8.4 \u200bISO 10993\u20113, tests for genotoxicity, carcinogenicity, and reproductive toxicity <\/td>\n<\/tr>\n
14<\/td>\n8.5 \u200bISO 10993\u20114, selection of tests for interactions with blood
8.6 \u200bISO 10993\u20115, tests for in vitro cytotoxicity
8.7 \u200bISO 10993\u20116, Tests for local effects after implantation <\/td>\n<\/tr>\n
15<\/td>\n8.8 \u200bISO 10993\u20117, ethylene oxide sterilization residuals
8.9 \u200bISO 10993\u20119, framework for identification and quantification of potential degradation products
8.10 \u200bISO 10993\u201110, tests for skin sensitization
8.11 \u200bISO 10993\u201111, tests for systemic toxicity <\/td>\n<\/tr>\n
16<\/td>\n8.12 \u200bISO 10993\u201112, sample preparation and reference materials
8.13 \u200bISO 10993\u201113, identification and quantification of degradation products from polymeric medical devices
8.14 \u200bISO 10993\u201114, identification and quantification of degradation products from ceramics <\/td>\n<\/tr>\n
17<\/td>\n8.15 \u200bISO 10993\u201115, identification and quantification of degradation products from metals and alloys
8.16 \u200bISO 10993\u201116, toxicokinetic study design for degradation products and leachables
8.17 \u200bISO 10993\u201117, establishment of allowable limits for leachable substances
8.18 \u200bISO 10993\u201118, chemical characterization of materials
8.19 \u200bISO\/TS 10993\u201119, physico-chemical, morphological and topographical characterization of materials <\/td>\n<\/tr>\n
18<\/td>\n8.20 \u200bISO\/TS 10993\u201120, principles and methods for immunotoxicology testing of medical devices
8.21 \u200bISO\/TR 10993\u201122, guidance on nanomaterials
8.22 \u200bISO 10993\u201123, tests for irritation
8.22.1 General
8.22.2 Tests for irritation <\/td>\n<\/tr>\n
19<\/td>\nAnnex A (informative) Nomenclature of absorb, degrade and related terms <\/td>\n<\/tr>\n
20<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

Biological evaluation of absorbable medical devices – General requirements<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
BSI<\/b><\/a><\/td>\n2021<\/td>\n22<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":371904,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[141,2641],"product_tag":[],"class_list":{"0":"post-371896","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-11-040-40","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\/371896","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\/371904"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=371896"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=371896"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=371896"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}