{"id":197969,"date":"2024-10-19T12:36:15","date_gmt":"2024-10-19T12:36:15","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/aami-tir10993-19-2006\/"},"modified":"2024-10-25T05:09:32","modified_gmt":"2024-10-25T05:09:32","slug":"aami-tir10993-19-2006","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/aami\/aami-tir10993-19-2006\/","title":{"rendered":"AAMI TIR10993 19 2006"},"content":{"rendered":"
Provides a compilation of parameters and test methods that can be useful for the identification and evaluation of the physico-chemical, morphological, and topographical (PMT) properties of materials in finished medical devices.<\/p>\n
PDF Pages<\/th>\n | PDF Title<\/th>\n<\/tr>\n | ||||||
---|---|---|---|---|---|---|---|
1<\/td>\n | ANSI\/AAMI\/ISO TIR10993-19:2006, Biological evaluation of medical devices – Part 19: Physico-chemical, morphological and topographical characterization of materials <\/td>\n<\/tr>\n | ||||||
3<\/td>\n | Copyright information <\/td>\n<\/tr>\n | ||||||
4<\/td>\n | AAMI Technical Information Report ANSI Technical Report <\/td>\n<\/tr>\n | ||||||
5<\/td>\n | Contents <\/td>\n<\/tr>\n | ||||||
6<\/td>\n | Glossary of equivalent standards <\/td>\n<\/tr>\n | ||||||
8<\/td>\n | Committee representation <\/td>\n<\/tr>\n | ||||||
10<\/td>\n | Background of AAMI adoption of ISO\/TS 10993-19:2006 <\/td>\n<\/tr>\n | ||||||
11<\/td>\n | Foreword <\/td>\n<\/tr>\n | ||||||
13<\/td>\n | Introduction <\/td>\n<\/tr>\n | ||||||
14<\/td>\n | 1 Scope 2 Normative references 3 Terms and definitions <\/td>\n<\/tr>\n | ||||||
15<\/td>\n | 4 Symbols and abbreviated terms <\/td>\n<\/tr>\n | ||||||
16<\/td>\n | 5 General principles <\/td>\n<\/tr>\n | ||||||
17<\/td>\n | 6 Characterization procedure 6.1 General 6.2 Qualitative information 6.3 Material equivalence <\/td>\n<\/tr>\n | ||||||
18<\/td>\n | 6.4 Quantitative information 6.5 Quantitative assessment 7 Characterization parameters and methods <\/td>\n<\/tr>\n | ||||||
22<\/td>\n | 8 Reporting of data obtained <\/td>\n<\/tr>\n | ||||||
23<\/td>\n | Annex A Principles for judging material equivalency <\/td>\n<\/tr>\n | ||||||
24<\/td>\n | Annex B Nanoparticles \u2014 Special consideration in judging material equivalency and biological evaluation <\/td>\n<\/tr>\n | ||||||
25<\/td>\n | Bibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" AAMI\/ISO TIR10993-19:2006 [HISTORICAL] Biological evaluation of medical devices\u2014Part 19: Physico-chemical, morphological, and topographical characterization of materials<\/b><\/p>\n |