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AAMI TIR12:2010

Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers
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AAMI TIR14:2016

Contract sterilization using ethylene oxide
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AAMI TIR15:2016 (PDF)

Physical aspects of ethylene oxide sterilization
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AAMI TIR16:2017 (PDF)

Microbiological aspects of ethylene oxide sterilization
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AAMI TIR17:2017 (PDF)

Compatibility of materials subject to sterilization
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AAMI TIR28:2016 (PDF)

Product adoption and process equivalence for ethylene oxide sterilization
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AAMI TIR29:2012/(R)2017 (PDF)

Guide for process characterization and control in radiation sterilization of medical devices
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AAMI TIR35:2016

Sterilization of health care products - Radiation sterilization - Alternative sampling plans for verification dose experiments and sterilization dose audits
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AAMI TIR37:2013

Sterilization of health care products—Radiation—Guidance on sterilization of biologics and tissue-based products
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AAMI TIR39:2009/(R)2017 (PDF)

Guidance on selecting a microbial challenge and inoculation sites for sterilization validation of medical devices
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AAMI TIR40:2018 (PDF)

Sterilization of health care products—Radiation—Guidance on dose setting utilizing a Modified Method 2
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AAMI TIR56:2013/(R)2016 (PDF)


Guidance for the development, validation and routine control of an ethylene oxide sterilization process utilizing flexible bag systems for the sterilization of medical devices
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AAMI TIR63: 2014/(R)2017 (PDF)

Management of loaned critical and semi-critical medical devices that require sterilization or high-level disinfection
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AAMI/ISO TIR13004:2013/(R)2016

Sterilization of health care products - Radiation - Substantiation of a selected sterilization dose: Method VDmaxSD
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AAMI/ISO TIR17665-2:2009/(R)2016 (PDF)

Sterilization of health care products - Moist Heat - Part 2: Guidance on the application of AAMI/ISO 17665-1
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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
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ANSI/AAMI ST40:2004/(R)2018 (PDF)

Table-top dry heat (heated air) sterilization and sterility assurance in health care facilities
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ANSI/AAMI ST41:2008/(R)2018 (PDF)

Ethylene oxide sterilization in health care facilities: Safety and effectiveness
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ANSI/AAMI ST58:2013/(R)2018 (PDF)

Chemical sterilization and high-level disinfection in health care facilities
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ANSI/AAMI ST67:2011/(R)2017 (PDF)

Sterilization of health care products—Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled ´sterile’
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