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80001 TIRs - Set of 4

The set of all four TIRs to aid users in applying 80001-1, application of risk management for IT networks incorporating medical devices. This set includes 80001-2-1:2012, 80001-2-2:2012, 80001-2-3:2012, and 80001-2-4:2012.
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AAMI CR500:2019

Basic Introduction to the IEC 60601 Series
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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 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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$137.00
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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
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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 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 TIR42:2010

Evaluation of particulates associated with vascular medical devices
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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 TIR49:2013

Design of training and instructional materials for medical devices used in non-clinical environments
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AAMI TIR50:2014/(R)2017 (PDF)

Post-market surveillance of use error management
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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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