This third edition cancels and replaces the second edition (ISO 10993-11:2006), which has been technically revised<\/p>\n
| PDF Pages<\/th>\n | PDF Title<\/th>\n<\/tr>\n | ||||||
|---|---|---|---|---|---|---|---|
| 1<\/td>\n | ANSI\/AAMI\/ISO 10993-11:2017; Biological evaluation of medical devices\u2014Part 11: Tests for systemic toxicity <\/td>\n<\/tr>\n | ||||||
| 3<\/td>\n | Title page <\/td>\n<\/tr>\n | ||||||
| 4<\/td>\n | AAMI Standard Copyright information <\/td>\n<\/tr>\n | ||||||
| 5<\/td>\n | Contents <\/td>\n<\/tr>\n | ||||||
| 6<\/td>\n | Committee representation <\/td>\n<\/tr>\n | ||||||
| 8<\/td>\n | Background of ANSI\/AAMI adoption of ISO 10993-11:2017 <\/td>\n<\/tr>\n | ||||||
| 9<\/td>\n | Foreword <\/td>\n<\/tr>\n | ||||||
| 10<\/td>\n | Introduction <\/td>\n<\/tr>\n | ||||||
| 11<\/td>\n | 1 Scope 2 Normative references 3 Terms and definitions <\/td>\n<\/tr>\n | ||||||
| 13<\/td>\n | 4 General considerations 4.1 General 4.2 Selection of animal species 4.3 Animal status 4.4 Animal care and husbandry 4.5 Size and number of groups 4.5.1 Size of groups <\/td>\n<\/tr>\n | ||||||
| 14<\/td>\n | Table 1\u2014Recommended minimum group sizes 4.5.2 Number of groups 4.5.3 Treatment controls 4.6 Route of exposure 4.7 Sample preparation <\/td>\n<\/tr>\n | ||||||
| 15<\/td>\n | 4.8 Dosing 4.8.1 Test sample administration 4.8.2 Dosage volumes 4.8.3 Dosage frequency 4.9 Body weight and food\/water consumption <\/td>\n<\/tr>\n | ||||||
| 16<\/td>\n | 4.10 Clinical observations 4.11 Clinical pathology 4.12 Anatomic pathology <\/td>\n<\/tr>\n | ||||||
| 17<\/td>\n | Table 2\u2014Summary of observations 4.13 Study designs 4.14 Quality of investigation 5 Acute systemic toxicity 5.1 General 5.2 Study design 5.2.1 Preparations <\/td>\n<\/tr>\n | ||||||
| 18<\/td>\n | 5.2.2 Experimental animals 5.2.2.1 Selection of species 5.2.2.2 Number and sex 5.2.2.3 Housing and feeding conditions 5.2.3 Test conditions 5.2.3.1 Dose levels 5.2.3.2 Procedure 5.2.4 Body weights 5.2.5 Clinical observations <\/td>\n<\/tr>\n | ||||||
| 19<\/td>\n | 5.2.6 Pathology 5.2.6.1 Clinical pathology 5.2.6.2 Gross pathology 5.2.6.3 Histopathology 5.3 Evaluation criteria 5.3.1 General <\/td>\n<\/tr>\n | ||||||
| 20<\/td>\n | 5.3.2 Evaluation of results 5.4 Final report <\/td>\n<\/tr>\n | ||||||
| 21<\/td>\n | 6 Repeated exposure systemic toxicity (subacute, subchronic and chronic systemic toxicity) 6.1 General <\/td>\n<\/tr>\n | ||||||
| 22<\/td>\n | 6.2 Study design 6.2.1 Preparations 6.2.2 Experimental animals 6.2.2.1 Selection of species 6.2.2.2 Number and sex 6.2.2.3 Housing and feeding conditions 6.2.3 Test conditions 6.2.3.1 Dose levels 6.2.3.2 Procedure 6.2.4 Body weights 6.2.5 Clinical observations <\/td>\n<\/tr>\n | ||||||
| 23<\/td>\n | 6.2.6 Pathology 6.2.6.1 Clinical pathology 6.2.6.2 Gross pathology 6.2.6.3 Histopathology <\/td>\n<\/tr>\n | ||||||
| 24<\/td>\n | 6.3 Evaluation criteria 6.3.1 General 6.3.2 Evaluation of results 6.4 Final report <\/td>\n<\/tr>\n | ||||||
| 25<\/td>\n | Annex A (informative) Routes of administration A.1 General A.2 Dermal A.3 Implantation A.4 Inhalation A.5 Intradermal A.6 Intramuscular A.7 Intraperitoneal <\/td>\n<\/tr>\n | ||||||
| 26<\/td>\n | A.8 Intravenous A.9 Oral A.10 Subcutaneous <\/td>\n<\/tr>\n | ||||||
| 27<\/td>\n | Annex B (informative) Dosage volumes B.1 General Table B.1\u2014Maximum single dosage volumes (ml\/kg) for test sample administration B.2 Dosage volume references <\/td>\n<\/tr>\n | ||||||
| 28<\/td>\n | Annex C (informative) Common clinical signs and observations Table C.1\u2014Common clinical signs and observations <\/td>\n<\/tr>\n | ||||||
| 29<\/td>\n | Annex D (informative) Suggested haematology, clinical chemistry and urinalysis measurements D.1 Haematology D.2 Clinical chemistry <\/td>\n<\/tr>\n | ||||||
| 30<\/td>\n | D.3 Urinalysis (timed collection, e.g. 16 h to 24 h) <\/td>\n<\/tr>\n | ||||||
| 31<\/td>\n | Annex E (informative) Suggested organ list for histopathological evaluation <\/td>\n<\/tr>\n | ||||||
| 33<\/td>\n | Annex F (informative) Organ list for limited histopathology for medical devices subjected to systemic toxicity testing F.1 General F.2 Procedure Table F.1\u2014Organ list for limited histopathology <\/td>\n<\/tr>\n | ||||||
| 34<\/td>\n | Annex G (informative) Information on material-mediated pyrogens <\/td>\n<\/tr>\n | ||||||
| 35<\/td>\n | Annex H (informative) Subchronic rat\u2014Dual routes of parenteral administration H.1 General Table H.1\u2014Recommended dosing parameters H.2 Procedure H.3 Dosage volume and frequency justification H.3.1 Intravenous H.3.2 Intraperitoneal <\/td>\n<\/tr>\n | ||||||
| 37<\/td>\n | Bibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" ANSI\/AAMI\/ISO 10993-11:2017, Biological evaluation of medical devices-Part 11: Tests for systemic toxicity<\/b><\/p>\n |