2017,AAMI,"ANSI/AAMI ST79:2017 - Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities" 2014,AAMI,"AAMI TIR63: 2014/(R)2017 - Management of loaned critical and semi-critical medical devices that require sterilization or high-level disinfection" 2017,AAMI,"ANSI/AAMI/ISO 11138-2:2017 - Sterilization of health care products-Biological indicators-Part 2: Biological indicators for ethylene oxide sterilization processes" 2017,AAMI,"ANSI/AAMI/ISO 11138-3:2017 - Sterilization of health care products-Biological indicators-Part 3: Biological indicators for moist heat sterilization processes" 2017,AAMI,"ANSI/AAMI/ISO 11138-4:2017 - Sterilization of health care products-Biological indicators-Part 4: Biological indicators for dry heat sterilization processes" 2017,AAMI,"ANSI/AAMI/ISO 11138-5:2017 - Sterilization of health care products-Biological indicators-Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes" 2014,AAMI,"AAMI TIR52:2014/(R)2017 - Environmental monitoring for terminally sterilized healthcare products" 2019,AAMI,"ANSI/AAMI/ISO 11607-2:2019 - Packaging for terminally sterilized medical devices-Part 2: Validation requirements for forming, sealing and assembly processes" 2013,AAMI,"ANSI/AAMI ST15883-2:2013/(R)2015 (ISO 15883-2:2006 MOD) - Washer-disinfectors - Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc." 2012,AAMI,"ANSI/AAMI ST15883-3:2012/(R)2015 - Washer-disinfectors, Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers" 2018,AAMI,"ANSI/AAMI/ISO 13408-2:2018 - Aseptic processing of health care products-Part 2: Sterilizing filtration" 2006,AAMI,"ANSI/AAMI/ISO 13408-3:2006/(R)2015 - Aseptic processing of health care products-Part 3: Lyophilization" 2005,AAMI,"ANSI/AAMI/ISO 13408-4-2005/(R)2014 - Aseptic processing of health care products-Part 4: Clean-in-place technologies" 2006,AAMI,"ANSI/AAMI/ISO 13408-5-2006/(R)2015 - Aseptic processing of health care products-Part 5: Sterilization in place" 2019,AAMI,"ANSI/AAMI ST67:2019 - Sterilization of health care products-Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled “sterile”" 2016,AAMI,"AAMI TIR14:2016 - Contract sterilization using ethylene oxide" 2016,AAMI,"AAMI TIR28:2016 - Product adoption and process equivalence for ethylene oxide sterilization" 2013,AAMI,"AAMI TIR37:2013 - Sterilization of health care products-Radiation-Guidance on sterilization of biologics and tissue-based products" 2012,AAMI,"ANSI/AAMI PB70:2012 - Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities" 2018,AAMI,"AAMI TIR68:2018 - Low and intermediate-level disinfection in healthcare settings for medical devices and patient care equipment and sterile processing environmental surfaces" 2014,AAMI,"ANSI/AAMI/ISO 11140-1:2014 - Sterilization of health care products - Chemical indicators - Part 1: General requirements" 2007,AAMI,"ANSI/AAMI/ISO 11140-3:2007/(R)2015 - Sterilization of health care products - Chemical indicators - Part 3: Class 2 indicator systems for use in the Bowie and Dick steam penetration test" 2007,AAMI,"ANSI/AAMI/ISO 11140-5:2007/(R)2015 - Sterilization of health care products - Chemical indicators - Part 5: Class 2 indicators for Bowie and Dick air removal test sheets and packs." 2019,AAMI,"ANSI/AAMI/ISO 11607-1:2019 - Packaging for terminally sterilized medical devices- Part 1: Requirements for materials, sterile barrier systems and packaging systems" 1999,AAMI,"ANSI/AAMI ST24:1999/(R)2018 - Automatic, general purpose ethylene oxide sterilizers and ethylene oxide sterilant sources intended for use in health care facilities" 2004,AAMI,"ANSI/AAMI ST50:2004/(R)2018 - Dry heat (heated air) sterilizers" 2013,AAMI,"ANSI/AAMI ST77:2013/(R)2018 - Containment devices for reusable medical device sterilization" 2016,AAMI,"ANSI/AAMI/ISO TIR19024:2016 - Evaluation of CPB devices relative to their capabilities of reducing the transmission of gaseous microemboli (GME) to a patient during cardiopulmonary bypass" 2014,AAMI,"AAMI TIR55:2014/(R)2017 - Human factors engineering for processing medical devices" 2019,AAMI,"ANSI/AAMI/ISO 11737-2:2019 - Sterilization of medical devices-Microbiological methods-Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process" 2012,AAMI,"ANSI/AAMI/ISO 13408-7:2012/(R)2018 - Aseptic processing of health care products-Part 7: Alternative processes for medical devices and combination products" 2016,AAMI,"AAMI TIR15:2016 - Physical aspects of ethylene oxide sterilization" 2017,AAMI,"AAMI TIR16:2017 - Microbiological aspects of ethylene oxide sterilization" 2018,AAMI,"AAMI TIR40:2018 - Sterilization of health care products-Radiation-Guidance on dose setting utilizing a Modified Method 2" 2018,AAMI,"ANSI/AAMI/ISO 11737-1:2018 - Sterilization of health care products-Microbiological methods-Part 1: Determination of a population of microorganisms on products" 2005,AAMI,"AAMI TIR11:2005/(R)2015 - Selection and use of protective apparel and surgical drapes in health care facilities" 2007,AAMI,"ANSI/AAMI/ISO 11140-4:2007/(R)2015 - Sterilization of health care products - Chemical indicators - Part 4: Class 2 indicators as an alternative to Bowie and Dick test for detection of steam penetration" 2016,AAMI,"ANSI/AAMI ST55:2016 - Table-top Steam Sterilizers" 2013,AAMI,"ANSI/AAMI/ST8:2013/(R)2018 - Hospital steam sterilizers" 2008,AAMI,"AAMI TIR31:2008 - Process challenge devices/test packs for use in health care facilities" 2008,AAMI,"ANSI/AAMI/ISO 15882:2008/(R)2013 - Sterilization of health care products - Chemical indicators-Guidance for selection, use and interpretation of results." 2017,AAMI,"ANSI/AAMI/ISO 17664:2017 - Processing of health care products-Information to be provided by the medical device manufacturer for the processing of medical devices" 2016,AAMI,"AAMI TIR35:2016 - Sterilization of health care products-Radiation sterilization-Alternative sampling plans for verification dose experiments and sterilization dose audits" 2009,AAMI,"ANSI/AAMI/ISO 14937:2009/(R) 2013 - 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" 2004,AAMI,"ANSI/AAMI ST40:2004/(R)2018 - Table-top dry heat (heated air) sterilization and sterility assurance in health care facilities" 2017,AAMI,"ANSI/AAMI ST90:2017 - Processing of health care products - Quality management systems for processing in health care facilities" 2011,AAMI,"AAMI TIR30:2011/(R)2016 - A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices" 2006,AAMI,"ANSI/AAMI/ISO 17665-1:2006/(R)2013 - Sterilization of health care products-Moist Heat-Guidance on the designation of a medical product to a product family and processing category for steam sterilization" 2012,AAMI,"AAMI TIR29:2012/(R)2017 - Guide for process characterization and control in radiation sterilization of medical devices" 2008,AAMI,"ANSI/AAMI ST65:2008/(R)2018 - Processing of reusable surgical textiles for use in health care facilities" 2014,AAMI,"AAMI TIR34: 2014/(R)2017 - Water for the reprocessing of medical devices" 2018,AAMI,"AAMI TIR67:2018 - Promoting safe practices pertaining to the use of sterilant and disinfectant chemicals in health care facilities" 2017,AAMI,"ANSI/AAMI/ISO 11138-1:2017 - Sterilization of health care products-Biological indicators-Part 1: General requirements" 2019,AAMI,"ANSI/AAMI/ISO 11138-7:2019 - Sterilization of health care products-Biological indicators-Part 7: Guidance for the selection, use and interpretation of results" 2006,AAMI,"ANSI/AAMI/ISO 11137-1:2006/(R)2015 & A1:2013 & A2:2019 - Sterilization of health care products-Radiation-Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices" 2017,AAMI,"ANSI/AAMI/ ISO 11137-2: 2013/(R)2019 - Sterilization of health care products-Radiation-Part 2: Establishing the sterilization dose" 2013,AAMI,"AAMI/ISO TIR13004:2013/(R)2016 - Sterilization of health care products-Radiation-Substantiation of a selected sterilization dose: Method VDmaxSD" 2008,AAMI,"ANSI/AAMI/ISO 13408-1:2008/(R)2017 & A1:2013 - Aseptic processing of health care products- Part 1: General requirements (includes Amendment 1)." 2011,AAMI,"ANSI/AAMI/ISO 14160:2011/(R)2016 - Sterilization of health care products-Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives-Requirements for characterization, development, validation and routine control of a sterilization process for medical devices" 2014,AAMI,"AAMI/ISO TIR17665-3:2014/(R)2016 - Sterilization of health care products-Moist Heat-Guidance on the designation of a medical product to a product family and processing category for steam sterilization" 2010,AAMI,"ANSI/AAMI/ISO 20857:2010/(R)2015 - Sterilization of health care products-Dry heat: Requirements for the development, validation and routine control of a sterilization process for medical devices" 2019,AAMI,"ANSI/AAMI ST72:2019, Bacterial endotoxins-Test methods, routine monitoring, and alternatives to batch testing" 2017,AAMI,"AAMI TIR17:2017 - Compatibility of materials subject to sterilization" 2013,AAMI,"ANSI/AAMI ST58:2013/(R)2018 - Chemical sterilization and high-level disinfection in health care facilities" 2009,AAMI,"ANSI/AAMI ST15883-1:2009/(R)2014 &A1:2014&A2:2012 - (Consolidated Text) (ISO 15883-1:2006, MOD) Washer-disinfectors-Part 1: General requirements, terms and definitions and tests" 2014,AAMI,"AAMI/ISO TIR16775:2014 - Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2" 2014,AAMI,"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" 2008,AAMI,"ANSI/AAMI ST41:2008/(R)2018 - Ethylene oxide sterilization in health care facilities: Safety and effectiveness" 2009,AAMI,"ANSI/AAMI/ISO TIR17665-2:2009/(R)2016 - Technical Information Report Sterilization of health care products – Moist Heat – Part 2: Guidance on the application of ANSI/AAMI/ISO 17665-1" 2017,AAMI,"ANSI/AAMI/ISO 11137-3-2017 - Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control" 2009,AAMI,"AAMI TIR39:2009/(R)2017 - Technical Information Report Guidance on selecting a microbial challenge and inoculation sites for sterilization validation of medical devices" 2005,AAMI,"ANSI/AAMI/ISO 13408-6:2005/(R)2013 & A1:2013 - Aseptic processing of health care products - Part 6: Isolator systems" 2016,AAMI,"AAMI TIR74: 2016 - Change summary for ISO 11135:2014, Sterilization of health care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices" 2020,AAMI,"AAMI TIR12:2020, Designing, testing, and labeling medical devices intended for processing by health care facilities: A guide for device manufacturers" 2021,AAMI,"ANSI/AAMI ST91:2021, Flexible and semi-rigid endoscope processing in health care facilities"