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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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$201.00 - $241.00
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$425.00
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AAMI TIR14:2016

Contract sterilization using ethylene oxide
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$69.00
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$123.00
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AAMI TIR15:2016 (PDF)

Physical aspects of ethylene oxide sterilization
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$87.00
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$152.00
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AAMI TIR16:2017 (PDF)

Microbiological aspects of ethylene oxide sterilization
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$87.00
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$152.00
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AAMI TIR17:2017 (PDF)

Compatibility of materials subject to sterilization
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$146.00
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$243.00
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AAMI TIR18:2010

Guidance on electromagnetic compatibility of medical devices in healthcare facilities
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$129.00
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$229.00
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TIR19 & A1 Combined

Guidance for ANSI/AAMI/ISO 10993-7:1995, Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
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$61.00
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$107.00
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AAMI TIR20:2001

Parametric release for ethylene oxide sterilization
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$87.00
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$152.00
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AAMI TIR28:2016 (PDF)

Product adoption and process equivalence for ethylene oxide sterilization
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$69.00
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$123.00
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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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$122.00
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$214.00
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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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$69.00
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$123.00
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AAMI TIR38:2014

Medical device safety assurance case guidance
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$129.00
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$229.00
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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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$69.00
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$123.00
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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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$87.00
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$152.00
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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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$69.00
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$107.00
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AAMI TIR42:2010

Evaluation of particulates associated with vascular medical devices
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$122.00
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$214.00
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AAMI TIR45:2012, Guidance on the use of AGILE practices Webinar

This webinar archive provides detailed information about AAMI TIR45:2012, Guidance on the use of AGILE practices in the development of medical device software and its recommendations for complying with international standards and FDA guidance documents when using AGILE practices to develop medical device software.
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$119.00
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$199.00
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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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$129.00
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$229.00
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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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$107.00
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$188.00
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AAMI TIR50:2014/(R)2017 (PDF)

Post-market surveillance of use error management
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$107.00
List Price:
$188.00
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