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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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ANSI/AAMI/ISO 14971:2007/(R)2016

Medical devices - Application of risk management to medical devices.
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$258.00
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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.
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AAMI RT2:2017 (PDF)

Radiation therapy readiness check
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Dialysis Standards Collection

The 2015 collection consists of 11 AAMI Hemodialysis standards, six of which were published in 2014
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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
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$222.00
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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 TIR16:2009/(R) 2013

Microbiological aspects of ethylene oxide sterilization.
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AAMI TIR17:2008

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 TIR19:1998 and A1:1999 (PDF Format)

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AAMI TIR20:2001

Parametric release for ethylene oxide sterilization
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AAMI TIR21:2017 (PDF)

Systems used to forecast remaining pacemaker battery service life
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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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$208.00
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AAMI TIR30:2011/(R)2016

A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices.
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AAMI TIR34:2014

Water for the reprocessing of medical devices
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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
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$183.00
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