Association for the Advancement of Medical Instrumentation (AAMI)

Association for the Advancement of Medical Instrumentation (AAMI)
AAMI (Association for the Advancement of Medical Instrumentation) is a non-profit organization that accredits manufacturers and suppliers of medical devices. Its accreditation program assesses compliance with quality and performance standards for medical devices. AAMI also provides guidelines and recommendations for the design, testing, and labeling of medical devices. By using AAMI-accredited devices, healthcare providers can ensure their patients receive safe and effective care.
AAMI TIR37:2013 [HISTORICAL]

AAMI TIR37:2013 [HISTORICAL]

Withdrawn Most Recent

Sterilization of health care products—Radiation—Guidance on sterilization of biologics and tissue-based products

€144.00

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ANSI/AAMI/ISO TIR13004:2013/(R)2016 [HISTORICAL]

ANSI/AAMI/ISO TIR13004:2013/(R)2016 [HISTORICAL]

Superseded Historical

Sterilization of health care products - Radiation - Substantiation of a selected sterilization dose: Method VDmaxSD

€268.00

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ANSI/AAMI ST58:2013/(R)2018 [HISTORICAL]

ANSI/AAMI ST58:2013/(R)2018 [HISTORICAL]

Withdrawn Most Recent

Chemical sterilization and high-level disinfection in health care facilities

€311.00

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ANSI/AAMI/ISO 5840-3:2013 [HISTORICAL]

ANSI/AAMI/ISO 5840-3:2013 [HISTORICAL]

Withdrawn Most Recent

Cardiovascular implants—Cardiac valve prostheses—Part 3: Heart valve substitutes implanted by transcatheter techniques.

€311.00

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ANSI/AAMI EQ56:2013 [HISTORICAL]

ANSI/AAMI EQ56:2013 [HISTORICAL]

Superseded Historical

Recommended practice for a medical equipment management program

€221.00

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AAMI TIR29:2012/(R)2017 [HISTORICAL]

AAMI TIR29:2012/(R)2017 [HISTORICAL]

Withdrawn Most Recent

Guide for process characterization and control in radiation sterilization of medical devices

€251.00

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AAMI TIR45:2012/(R)2018 [HISTORICAL]

AAMI TIR45:2012/(R)2018 [HISTORICAL]

Superseded Historical

Guidance on the use of AGILE practices in the development of medical device software

€268.00

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ANSI/AAMI PB70:2012 [HISTORICAL]

ANSI/AAMI PB70:2012 [HISTORICAL]

Withdrawn Most Recent

Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities

€178.00

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AAMI TIR30:2011/(R)2016 [HISTORICAL]

AAMI TIR30:2011/(R)2016 [HISTORICAL]

Withdrawn Most Recent

A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices

€251.00

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ANSI/AAMI HE75:2009/(R)2018 [HISTORICAL]

ANSI/AAMI HE75:2009/(R)2018 [HISTORICAL]

Superseded Historical

Human factors engineering—Design of medical devices

€471.00

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ANSI/AAMI ST41:2008/(R)2018 [HISTORICAL]

ANSI/AAMI ST41:2008/(R)2018 [HISTORICAL]

Withdrawn Most Recent

Ethylene oxide sterilization in health care facilities: Safety and effectiveness

€328.00

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ANSI/AAMI/ISO 13408-1:2008/(R)2017 & A1:2013/(R)2017 [HISTORICAL]

ANSI/AAMI/ISO 13408-1:2008/(R)2017 & A1:2013/(R)2017 [HISTORICAL]

Withdrawn Most Recent

Aseptic processing of health care products—Part 1: General requirements (includes Amendment 1)

€268.00

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AAMI/ISO TIR10993-19:2006 [HISTORICAL]

AAMI/ISO TIR10993-19:2006 [HISTORICAL]

Superseded Historical

Biological evaluation of medical devices—Part 19: Physico-chemical, morphological, and topographical characterization of materials

€144.00

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ANSI/AAMI ST24:1999/(R)2018 [HISTORICAL]

ANSI/AAMI ST24:1999/(R)2018 [HISTORICAL]

Superseded Historical

Automatic, general purpose ethylene oxide sterilizers and ethylene oxide sterilant sources intended for use in health care facilities

€178.00

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