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AAMI TIR41:2011/(R)2020

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
$74.00
$131.00
$131.00
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AAMI CR500:2019

Basic Introduction to the IEC 60601 Series
$93.00
$162.00
$162.00
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AAMI RT2:2017 (PDF)

Radiation therapy readiness check
$0.00
$0.00
$0.00
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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
$160.00
$282.00
$282.00
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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
$137.00
$243.00
$243.00

AAMI TIR14:2016

Contract sterilization using ethylene oxide
$74.00
$131.00
$131.00

AAMI TIR15:2016 (PDF)

Physical aspects of ethylene oxide sterilization
$93.00
$162.00
$162.00
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AAMI TIR16:2017 (PDF)

Microbiological aspects of ethylene oxide sterilization
$93.00
$162.00
$162.00
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AAMI TIR17:2017 (PDF)

Compatibility of materials subject to sterilization
$156.00
$259.00
$259.00
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AAMI TIR18:2010

Guidance on electromagnetic compatibility of medical devices in healthcare facilities
$137.00
$243.00
$243.00
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AAMI TIR28:2016 (PDF)

Product adoption and process equivalence for ethylene oxide sterilization
$74.00
$131.00
$131.00
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AAMI TIR29:2012/(R)2017 (PDF)

Guide for process characterization and control in radiation sterilization of medical devices
$130.00
$228.00
$228.00
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AAMI TIR34:2014/(R)2017

Water for the reprocessing of medical devices
$144.00
$243.00
$243.00
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AAMI TIR37:2013

Sterilization of health care products—Radiation—Guidance on sterilization of biologics and tissue-based products
$74.00
$131.00
$131.00
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AAMI TIR38:2019

Medical device safety assurance case guidance
$137.00
$243.00
$243.00
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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
$74.00
$131.00
$131.00
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AAMI TIR45:2012/(R)2018

Guidance on the use of AGILE practices in the development of medical device software
$137.00
$243.00
$243.00
Available for Immediate Download

AAMI TIR48:2015

Quality Management System (QMS) Recommendations on the Application of the U.S. FDA's CGMP Final Rule on Combination Products
$160.00
$282.00
$282.00
Available for Immediate Download

AAMI TIR51:2014/(R)2017 (PDF)

Human factors engineering - Guidance for contextual inquiry
$74.00
$131.00
$131.00
Available for Immediate Download

AAMI TIR52:2014/(R)2017 (PDF)

Environmental monitoring for terminally sterilized healthcare products
$65.00
$114.00
$114.00
Available for Immediate Download