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ANSI/AAMI ES60601-1:2005/(R)2012, (IEC 60601-1:2005, MOD)

This standard incorporates Amendment 1 with changes highlighted in the text.
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$1,060.00
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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.
$246.00 - $256.00
$451.00
$451.00

AAMI HIT1000-1(PS):2018 (PDF)

Safety and effectiveness of health IT software and systems-Part 1: Fundamental concepts, principles, and requirements
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AAMI RT2:2017 (PDF)

Radiation therapy readiness check
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AAMI TIR11:2005/(R)2015

Selection and use of protective apparel and surgical drapes in health care facilities
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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
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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 TIR30:2011/(R)2016 (PDF)


A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices
$136.00
$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 TIR35:2016

Sterilization of health care products - Radiation sterilization - Alternative sampling plans for verification dose experiments and sterilization dose audits
$114.00
$200.00
$200.00

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 TIR40:2018 (PDF)

Sterilization of health care products—Radiation—Guidance on dose setting utilizing a Modified Method 2
$93.00
$162.00
$162.00
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AAMI TIR42:2010

Evaluation of particulates associated with vascular medical devices
$130.00
$228.00
$228.00
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AAMI TIR43:2011

Ultrapure dialysate for hemodialysis and related therapies
$74.00
$131.00
$131.00
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