AAMI TIR16:2023
Current
Current
The latest, up-to-date edition.
Microbiological aspects of ethylene oxide sterilization
Available format(s)
Hardcopy , PDF
Language(s)
English
Published date
18-12-2023
Important note : Users cannot be edited or removed once added to your Multi user PDF.Addresses various microbiological aspects of the development and validation of an ethylene oxide sterilization process.
| DocumentType |
Standard
|
| ISBN |
978-1-57020-878-2
|
| Pages |
52
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Current
|
| Supersedes |
| ANSI/AAMI/ISO 11737-2:2019 | <br>Sterilization of medical devices—Microbiological methods—Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process |
| ANSI/AAMI/ISO 11135:2014 | STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
| AAMI TIR15:2016(R2020) | Physical aspects of ethylene oxide sterilization |
| AAMI ISO 14937:2009 | STERILIZATION OF HEALTH CARE PRODUCTS - GENERAL REQUIREMENTS FOR CHARACTERIZATION OF A STERILIZING AGENT AND THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
| ANSI/AAMI/ISO 11138-2:2017 | STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 2: BIOLOGICAL INDICATORS FOR ETHYLENE OXIDE STERILIZATION PROCESSES |
| AAMI TIR34:2014(R2021) | Water for the reprocessing of medical devices |
| AAMI TIR56:2013(R2020) | GUIDANCE FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF AN ETHYLENE OXIDE STERILIZATION PROCESS UTILIZING FLEXIBLE BAG SYSTEMS FOR THE STERILIZATION OF MEDICAL DEVICES |
| ANSI/AAMI/ISO 11138-1:2017 | STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 1: GENERAL REQUIREMENTS |
| ANSI/AAMI ST79:2017 | COMPREHENSIVE GUIDE TO STEAM STERILIZATION AND STERILITY ASSURANCE IN HEALTH CARE FACILITIES |
| ANSI/AAMI/ISO 11737-1:2018 | Sterilization of health care products—Microbiological methods—Part 1: Determination of a population of microorganisms on products |
| AAMI TIR28:2016(R2020) | Product adoption and process equivalence for ethylene oxide sterilization |
| ANSI/AAMI ST67:2019 | Sterilization of health care products—Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled “sterile” |
| AAMI TIR14:2016(R2020) | Contract sterilization using ethylene oxide |
| ANSI/AAMI ST98:2022 | CLEANING VALIDATION OF HEALTH CARE PRODUCTS—REQUIREMENTS FOR DEVELOPMENT AND VALIDATION OF A CLEANING PROCESS FOR MEDICAL DEVICES |
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