{"id":279707,"date":"2024-10-19T18:53:04","date_gmt":"2024-10-19T18:53:04","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-en-iso-10993-162017\/"},"modified":"2024-10-25T15:27:21","modified_gmt":"2024-10-25T15:27:21","slug":"bs-en-iso-10993-162017","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-en-iso-10993-162017\/","title":{"rendered":"BS EN ISO 10993-16:2017"},"content":{"rendered":"

This document provides principles on designing and performing toxicokinetic studies relevant to medical devices. Annex A describes the considerations for inclusion of toxicokinetic studies in the biological evaluation of medical devices.<\/p>\n

PDF Catalog<\/h4>\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
4<\/td>\nEuropean 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
11<\/td>\n4 Principles for design of toxicokinetic studies
5 Guidance on test methods
5.1 General considerations <\/td>\n<\/tr>\n
13<\/td>\n5.2 Guidance on specific types of test
5.2.1 General
5.2.2 Absorption
5.2.3 Distribution <\/td>\n<\/tr>\n
14<\/td>\n5.2.4 Metabolism and excretion <\/td>\n<\/tr>\n
15<\/td>\nAnnex A (normative) Circumstances in which toxicokinetic studies shall be considered <\/td>\n<\/tr>\n
17<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

Biological evaluation of medical devices – Toxicokinetic study design for degradation products and leachables<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
BSI<\/b><\/a><\/td>\n2018<\/td>\n28<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":279714,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[162,2641],"product_tag":[],"class_list":{"0":"post-279707","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\/279707","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\/279714"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=279707"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=279707"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=279707"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}