{"id":279225,"date":"2024-10-19T18:50:05","date_gmt":"2024-10-19T18:50:05","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-en-iso-10993-122012\/"},"modified":"2024-10-25T15:24:01","modified_gmt":"2024-10-25T15:24:01","slug":"bs-en-iso-10993-122012","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-en-iso-10993-122012\/","title":{"rendered":"BS EN ISO 10993-12:2012"},"content":{"rendered":"
PDF Pages<\/th>\n | PDF Title<\/th>\n<\/tr>\n | ||||||
---|---|---|---|---|---|---|---|
8<\/td>\n | Foreword <\/td>\n<\/tr>\n | ||||||
9<\/td>\n | Introduction <\/td>\n<\/tr>\n | ||||||
11<\/td>\n | 1\tScope 2\tNormative references 3\tTerms and definitions <\/td>\n<\/tr>\n | ||||||
13<\/td>\n | 4\tGeneral requirements <\/td>\n<\/tr>\n | ||||||
14<\/td>\n | 5\tReference materials (RMs) 5.1\tGeneral 5.2\tCertification of RMs for biological safety testing 6\tUse of RMs as experimental controls <\/td>\n<\/tr>\n | ||||||
15<\/td>\n | 7\tTest sample selection 8\tTest sample and RM preparation 9\tSelection of representative portions from a device <\/td>\n<\/tr>\n | ||||||
16<\/td>\n | 10\tPreparation of extracts of samples 10.1\tGeneral 10.2\tContainers for extraction 10.3\tExtraction conditions and methods <\/td>\n<\/tr>\n | ||||||
19<\/td>\n | 10.4\tExtraction conditions for hazard identification and risk estimation in the\u00a0exaggerated-use condition (points to consider in relation to Annex\u00a0D) 11\tRecords <\/td>\n<\/tr>\n | ||||||
20<\/td>\n | Annex\u00a0A \n(informative)<\/p>\n Experimental controls <\/td>\n<\/tr>\n | ||||||
22<\/td>\n | Annex\u00a0B \n(informative)<\/p>\n General principles on, and practices of, | ||||||
24<\/td>\n | Annex\u00a0C \n(informative)<\/p>\n Principles of test sample extraction <\/td>\n<\/tr>\n | ||||||
27<\/td>\n | Annex\u00a0D \n(informative)<\/p>\n Exhaustive extraction of polymeric materials for biological evaluation <\/td>\n<\/tr>\n | ||||||
29<\/td>\n | Bibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" Biological evaluation of medical devices – Sample preparation and reference materials<\/b><\/p>\n |