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AAMI RT2:2017 (PDF)

Radiation therapy readiness check
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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 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 TIR18:2010

Guidance on electromagnetic compatibility of medical devices in healthcare facilities
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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 TIR34:2014/(R)2017

Water for the reprocessing of medical devices
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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 TIR38:2019

Medical device safety assurance case guidance
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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 TIR41:2011/(R)2017

Active Implantable Medical Devices - Guidance for Designation of Left Ventricle and Implantable Cardioverter Defibrillator Lead Connectors and Pulse Generator Connector Cavities for Implantable Pacemakers and Implantable Cardioverter Defibrillators
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AAMI TIR45:2012/(R)2018

Guidance on the use of AGILE practices in the development of medical device software
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AAMI TIR48:2015

Quality Management System (QMS) Recommendations on the Application of the U.S. FDA's CGMP Final Rule on Combination Products
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AAMI TIR51:2014/(R)2017 (PDF)

Human factors engineering - Guidance for contextual inquiry
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AAMI TIR52:2014/(R)2017 (PDF)

Environmental monitoring for terminally sterilized healthcare products
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AAMI TIR55:2014/(R)2017 (PDF)

Human factors engineering for processing medical devices
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