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AAMI TIR102:2019

U.S. FDA 21 CFR mapping to the applicable regulatory requirement references in ISO 13485:2016 Quality Management Systems
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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 TIR28:2016 (PDF)

Product adoption and process equivalence for ethylene oxide sterilization
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AAMI TIR30:2011/(R)2016 (PDF)


A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable 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 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 TIR57:2016/(R)2019

Principles for medical devices security—Risk management
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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
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AAMI TIR97:2019

Principles for medical device security—Postmarket risk management for device manufacturers
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AAMI/IEC TIR62366-2:2016

Medical Devices Part 2: Guidance on the Application of Usability Engineering to Medical Devices.
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AAMI/IEC TIR80001-2-8:2016 (PDF)

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AAMI/IEC TIR80002-3:2016

Technical Information Report Medical Device Software - Part 3: Process reference model of medical device software life cycle processes (IEC 62304)
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AAMI/ISO 13485:2016

Medical Devices—A Practical Guide, Advice from ISO/TC 210
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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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AAMI/ISO TIR22442-4:2011/(R)2016

Medical devices utilizing animal tissues and their derivatives -- Part 4: Principles for elimination and/or inactivation of transmissible spongiform encephalopathy (TSE) agents and validation assays for those processes.
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ANSI/AAMI BP22:1994/(R)2016

Blood Pressure Transducers
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ANSI/AAMI ST55:2016 (PDF)

Table-top Steam Sterilizers
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