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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.
$256.00
$451.00
$451.00

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
Available for Immediate Download

AAMI CR500:2019

Basic Introduction to the IEC 60601 Series
$93.00
$162.00
$162.00
Available for Immediate Download

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
Available for Immediate Download

AAMI TIR16:2017 (PDF)

Microbiological aspects of ethylene oxide sterilization
$93.00
$162.00
$162.00
Available for Immediate Download

AAMI TIR17:2017 (PDF)

Compatibility of materials subject to sterilization
$156.00
$259.00
$259.00
Available for Immediate Download

AAMI TIR18:2010

Guidance on electromagnetic compatibility of medical devices in healthcare facilities
$137.00
$243.00
$243.00
Available for Immediate Download

AAMI TIR28:2016 (PDF)

Product adoption and process equivalence for ethylene oxide sterilization
$74.00
$131.00
$131.00
Available for Immediate Download

AAMI TIR29:2012/(R)2017 (PDF)

Guide for process characterization and control in radiation sterilization of medical devices
$130.00
$228.00
$228.00
Available for Immediate Download

AAMI TIR37:2013

Sterilization of health care products—Radiation—Guidance on sterilization of biologics and tissue-based products
$74.00
$131.00
$131.00
Available for Immediate Download

AAMI TIR38:2019

Medical device safety assurance case guidance
$137.00
$243.00
$243.00
Available for Immediate Download

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
Available for Immediate Download

AAMI TIR40:2018 (PDF)

Sterilization of health care products—Radiation—Guidance on dose setting utilizing a Modified Method 2
$93.00
$162.00
$162.00
Available for Immediate Download

AAMI TIR42:2010

Evaluation of particulates associated with vascular medical devices
$130.00
$228.00
$228.00
Available for Immediate Download

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 TIR49:2013/(R)2020

Design of training and instructional materials for medical devices used in non-clinical environments
$130.00
$228.00
$228.00
Available for Immediate Download

AAMI TIR50:2014/(R)2017 (PDF)

Post-market surveillance of use error management
$114.00
$200.00
$200.00
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