AAMI Biological Standards Collection
This collection contains documents from the following standards organization(s): Association for the Advancement of Medical Instrumentation
| AAMI 10993-12 | EN-Biological evaluation of medical devices - Part 12: Sample preparation and reference materials | |
| AAMI 10993-13 | EN-Biological evaluation of medical devices Part 13: Identification and quantification of degradation products from polymeric devices. | |
| AAMI 10993-14 | EN-BIOLOGICAL EVALUATION OF MEDICAL DEVICES PART 14: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCT FROM CERAMICS | |
| AAMI 10993-15 | EN-Biological evaluation of medical devices- Part 15: Identification and quantification of degradation products from metals and alloys | |
| AAMI 10993-16 | EN-Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables | |
| AAMI 10993-17 | EN-Biological evaluation of medical devices- Part 17: Methods for the establishment of allowable limits for leachable substances | |
| AAMI 10993-2 | EN-Biological evaluation of medical devices - Part 2: Animal welfare requirements | |
| AAMI 10993-3 | EN-Biological evaluation of medical devices-Part 3: Tests for genotoxicity carcinogenicity and reproductive toxicity | |
| AAMI 10993-4 | EN-Biological evaluation of medical devices- Part 4: Selection of tests for interaction with blood-Incorporates Amendment 1: 2006 | |
| AAMI 10993-5 | EN-Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity | |
| AAMI 10993-6 | EN-BIOLOGICAL EVALUATION OF MEDICAL DEVICES PART 6: TESTS FOR LOCAL EFFECTS AFTER IMPLANTATION | |
| AAMI 10993-9 | EN-Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products | |
| AAMI 14155-1 | EN-Clinical investigation of medical devices for human subjects - Part 1: General requirements | |
| AAMI 14155-2 | EN-Clinical investigation of medical devices for human subjects-Part 2: Clinical investigation plans | |
| AAMI 22442-1 | EN-Medical devices utilizing animal tissues and their derivatives-Part 1: Application of risk management | |
| AAMI 22442-2 | EN-Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing collection and handling | |
| AAMI 22442-3 | EN-Medical devices utilizing animal tissues and their derivatives-Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents | |
| AAMI BE78 | EN-Biological evaluation of medical devices- Part 10: Tests for irritation and delayed-type hypersensitivity-FDA RECOGNIZED; Incorporating Reaffirmed Amendment 1: 12/3/2008 | |
| AAMI BE83 | EN-Biological evaluation of medical devices - Part 18: Chemical characterization of materials | |
| AAMI TIR10993-19 | EN-Biological evaluation of medical devices - Part 19: Physico-chemical morphological and topographical characterization of materials | |
| AAMI TIR10993-20 | EN-Biological evaluation of medical devices - Part 20: Principles and methods for immunotoxicology testing of medical devices |