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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

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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