AAMI TIR14:2016(R2024)
Current
Contract sterilization using ethylene oxide
English
03-26-2024
This AAMI TIR provides guidance that augments ANSI/AAMI/ISO 11135:2014, both for medical manufacturers that use contract sterilization facilities and for contract sterilization operations.
| DocumentType |
Standard
|
| ISBN |
9781570206139
|
| Pages |
20
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Current
|
| Supersedes |
| ANSI/AAMI/ISO 10993-5:2009(R2022) | Biological evaluation of medical devices—Part 5: Tests for in vitro cytotoxicity |
| ANSI/AAMI/ISO 10993-10:2010(R2014) | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 10: TESTS FOR IRRITATION AND SKIN SENSITIZATION |
| ANSI/AAMI/ISO 10993-3:2014 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 3: TESTS FOR GENOTOXICITY, CARCINOGENICITY, AND REPRODUCTIVE TOXICITY |
| ANSI/AAMI/ISO 11607-2:2019 | Packaging for terminally sterilized medical devices—Part 2: Validation requirements for forming, sealing and assembly processes |
| AAMI ST72 : 2011 | BACTERIAL ENDOTOXIN - TEST METHODS, ROUTINE MONITORING AND ALTERNATIVES TO BATCH TESTING |
| ANSI/AAMI/ISO 10993-4:2002(R2009) | Biological evaluation of medical devices— Part 4: Selection of tests for interaction with blood |
| ANSI/AAMI/ISO 10993-6:2016 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 6: TESTS FOR LOCAL EFFECTS AFTER IMPLANTATION |
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