AAMI Sterilization Standards Collection
This collection contains documents from the following standards organization(s): Association for the Advancement of Medical Instrumentation
| AAMI 11137-2 | EN-Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose-Also replaces AAMI ST31 AAMI ST32 AAMI TIR5 and AAMI TIR27 | |
| AAMI 11137-3 | EN-Sterilization of health care products-Radiation-Part 3: Guidance on dosimetric aspects | |
| AAMI 11138-1 | EN-Sterilization of health care products - Biological indicators - Part 1: General requirements | |
| AAMI 11138-2 | EN-Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes | |
| AAMI 11138-3 | EN-Sterilization of health care products-Biological indicators-art 3: Biological indicators for moist heat sterilization processes | |
| AAMI 11138-4 | EN-Sterilization of health care products-Biological indicators-Part 4: Biological indicators for dry heat sterilization processes | |
| AAMI 11138-5 | EN-Sterilization of health care products-Biological indicators-Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes | |
| AAMI 11140-1 | EN-Sterilization of health care products-Chemical indicators-Part 1: General requirements | |
| AAMI 11140-3 | EN-Sterilization of health care products - Chemical indicators - Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test | |
| AAMI 11140-4 | EN-Sterilization of health care products - Chemical indicators - Part 4: Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration | |
| AAMI 11140-5 | EN-Sterilization of health care products - Chemical indicators - Part 5: Class 2 indicators for Bowie and Dick-type air removal tests | |
| AAMI 11607-1 | EN-Packaging for terminally sterilized medical devices - Part 1: Requirements for materials sterile barrier systems and packaging | |
| AAMI 11607-2 | EN-Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming sealing and assembly processes | |
| AAMI 11737-1 | EN-Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products | |
| AAMI 14160 | EN-Sterilization of single-use medical devices incorporating materials of animal origin-Validation and routine control of sterilization by liquid chemical sterilants | |
| AAMI 15882 | EN-Sterilization of health care products - Chemical indicators - Guidance for selection use and interpretation of results | |
| AAMI 17665-1 | EN-Sterilization of health care products - Moist heat - Part 1 Requirements for the development validation and routine control of a sterilization process for medical devices-Former Designation: AAMI ST25 | |
| AAMI 18472 | EN-Sterilization of health care products - Biological and chemical indicators - Test equipment | |
| AAMI ST24 | EN-Automatic general purpose ethylene oxide sterilizers and ethylene oxide sterilant sources intended for use in health care facilities | |
| AAMI ST40 | EN-Table-top dry heat (heated air) sterilization and sterility assurance in health care facilitie | |
| AAMI ST41 | EN-Ethylene oxide sterilization in health care facilities: Safety and effectiveness-FDA RECOGNIZED; Corrected 31 March 2010: Includes change to subclause 10.7.6.1 | |
| AAMI ST50 | EN-Dry heat (heated air) sterilizers-FDA RECOGNIZED | |
| AAMI ST55 | EN-Table-top steam sterilizers-FDA RECOGNIZED | |
| AAMI ST58 | EN-Chemical sterilization and high-level disinfection in health care facilities | |
| AAMI ST63 | EN-Sterilization of health care products-Requirements for the development validation and routine control of an industrial sterilization process for medical devices-Dry heat-FDA RECOGNIZED | |
| AAMI ST65 | EN-Processing of reusable surgical textiles for use in health care facilities-FDA RECOGNIZED | |
| AAMI ST67 | EN-Sterilization of health care products-Requirements for products labeled -STERILE--FDA RECOGNIZED | |
| AAMI ST72 | EN-Bacterial endotoxins-Test methodologies routine monitoring and alternatives to batch testing-FDA RECOGNIZED | |
| AAMI ST77 | EN-Containment devices for reusable medical device sterilization | |
| AAMI ST79 | EN-Comprehensive guide to steam sterilization and sterility assurance in health care facilities-Incorporates Amendment 1: 2008; Amendment 2: 2009 | |
| AAMI ST8 | EN-Hospital steam sterilizers-FDA RECOGNIZED | |
| AAMI ST81 | EN-Sterilization of medical devices-Information to be provided by the manufacturer for the processing of resterilizable medical devices | |
| AAMI TIR11 | EN-Selection and use of protective apparel and surgical drapes in health care facilities | |
| AAMI TIR11139 | EN-Sterilization of health care products - Vocabulary | |
| AAMI TIR12 | EN-Designing Testing and Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: A Guide for Device Manufacturers-2nd Edition | |
| AAMI TIR14 | EN-Contract sterilization using ethylene oxide | |
| AAMI TIR16 | EN-Microbiological aspects of ethylene oxide sterilization | |
| AAMI TIR17 | EN-Compatibility of materials subject to sterilization | |
| AAMI TIR19 | EN-Guidance for ANSI/AAMI/ISO 10993-7:1995 Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals-Replaces AAMI ST29 and AAMI ST30; Cited as relevant guidance to FDA-recognized standa | |
| AAMI TIR19 AMD 1 | EN-Guidance for ANSI/AAMI/ISO 10993-7:1995 Biological evaluation of medical deices-Part 7: Ethylene oxide sterilization residuals Amendment | |
| AAMI TIR20 | EN-PARAMETRIC RELEASE FOR ETHYLENE OXIDE STERILIZATION-Cited by FDA as "relevant guidance" for ANSI/AAMI/ISO 11135: 1994 | |
| AAMI TIR22 | EN-Guidance for ANSI/AAMI/ISO 11607 Packaging for terminally sterilized medical devices- Part 1 and Part 2:2006-Incorporates Amendment 1: 2008 | |
| AAMI TIR28 | EN-Product adoption and process equivalence for ethylene oxide sterilization | |
| AAMI TIR30 | EN-A Compendium of processes materials test methods and acceptance criteria for cleaning reusable medical devices | |
| AAMI TIR31 | EN-PROCESS CHALLENGE DEVICES/TEST PACKS FOR USE IN HEALTH CARD FACILITIES | |
| AAMI TIR33 | EN-Sterilization of health care products - Radiation - Substantiation of a selected sterilization dose - Method VDmax | |
| AAMI TIR34 | EN-Water for the reprocessing of medical devices |