{"id":449490,"date":"2024-10-20T09:03:07","date_gmt":"2024-10-20T09:03:07","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/aami-tir10993-20-2006-r2021\/"},"modified":"2024-10-26T16:55:19","modified_gmt":"2024-10-26T16:55:19","slug":"aami-tir10993-20-2006-r2021","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/aami\/aami-tir10993-20-2006-r2021\/","title":{"rendered":"AAMI TIR10993 20 2006 R2021"},"content":{"rendered":"

This standard covers current state of knowledge in the area of immunotoxicology, including information on methods of assessment and their predictive value; to identify what the problems are and how they have been dealt with in the past; and offers advice on how the problems should be addressed in future standards.<\/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>\nAAMI\/ISO TIR10993-20:2006\/(R)2021, Biological evaluation of medical devices – Part 20: Principles and methods for immunotoxicology testing of medical devices <\/td>\n<\/tr>\n
2<\/td>\nTitle page <\/td>\n<\/tr>\n
3<\/td>\nCopyright information <\/td>\n<\/tr>\n
4<\/td>\nAAMI technical information report
ANSI technical report <\/td>\n<\/tr>\n
5<\/td>\nContents <\/td>\n<\/tr>\n
6<\/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\/TS 10993-20:2006 <\/td>\n<\/tr>\n
11<\/td>\nForeword <\/td>\n<\/tr>\n
13<\/td>\nIntroduction <\/td>\n<\/tr>\n
14<\/td>\n1 Scope
2 Normative references
3 Terms and definitions <\/td>\n<\/tr>\n
15<\/td>\n4 Risk assessment and risk management <\/td>\n<\/tr>\n
16<\/td>\n5 Identification of hazards <\/td>\n<\/tr>\n
18<\/td>\n6 Methods of assessment of immunotoxicity
6.1 General <\/td>\n<\/tr>\n
19<\/td>\n6.2 Inflammation
6.3 Immunosuppression <\/td>\n<\/tr>\n
21<\/td>\n6.4 Immunostimulation
6.5 Hypersensitivity
6.6 Auto-immunity
7 Extrapolation of data provided by pre-clinical assays <\/td>\n<\/tr>\n
23<\/td>\nAnnex A (informative) Current state of knowledge
A.1 Immunology <\/td>\n<\/tr>\n
24<\/td>\nA.2 Immunotoxicology <\/td>\n<\/tr>\n
25<\/td>\nA.3 Human health consequences of changes in the immune system <\/td>\n<\/tr>\n
27<\/td>\nAnnex B (informative) Clinical experience with medical devices <\/td>\n<\/tr>\n
29<\/td>\nAnnex C (informative) Flow chart for immunotoxicity testing <\/td>\n<\/tr>\n
30<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

AAMI\/ISO TIR10993-20:2006 (R2021) – Biological Evaluation Of Medical Devices – Part 20: Principles And Methods For Immunotoxicology Testing Of Medical Devices<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
AAMI<\/b><\/a><\/td>\n2006<\/td>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":449495,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2654],"product_tag":[],"class_list":{"0":"post-449490","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\/449490","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\/449495"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=449490"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=449490"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=449490"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}