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 HIT1000-3(PS):2019

AAMI HIT1000-3(PS):2019

Active Most Recent

Safety and effectiveness of health IT software and systems—Part 3: Application of risk management

€21.00

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AAMI TIR102:2019

AAMI TIR102:2019

Active Most Recent

U.S. FDA 21 CFR mapping to the applicable regulatory requirement references in ISO 13485:2016 Quality Management Systems

€311.00

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AAMI TIR11:2005/(R)2021

AAMI TIR11:2005/(R)2021

Active Most Recent

Selection and use of protective apparel and surgical drapes in health care facilities

€221.00

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AAMI TIR21:2017/(R)2025

AAMI TIR21:2017/(R)2025

Active Most Recent

Systems used to forecast remaining pacemaker battery service life

€268.00

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AAMI TIR23:1999/(R)2019

AAMI TIR23:1999/(R)2019

Active Most Recent

Signal averaging

€221.00

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AAMI TIR24:1999/(R)2025

AAMI TIR24:1999/(R)2025

Active Most Recent

Acquisition and use of physiologic waveform databases for testing of medical devices

€251.00

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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Withdrawn Most Recent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 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Withdrawn Most Recent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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AAMI TIR31:2008

AAMI TIR31:2008

Active Most Recent

Process challenge devices/test packs for use in health care facilities

€221.00

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AAMI TIR62:2014/(R)2025

AAMI TIR62:2014/(R)2025

Active Most Recent

Generating reports for the purpose of submitting defibrillation waveform data for evaluation

€126.00

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AAMI TIR65:2015/(R)2022

AAMI TIR65:2015/(R)2022

Active Most Recent

Sustainability of medical devices—Elements of a responsible product life cycle

€251.00

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AAMI TIR35:2016/(R)2021

AAMI TIR35:2016/(R)2021

Active Most Recent

Sterilization of health care products—Radiation sterilization—Product adoption and alternative sampling plans for verification dose experiments and sterilization dose audits

€221.00

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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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AAMI TIR38:2019

AAMI TIR38:2019

Active Most Recent

Medical device safety assurance case guidance

€268.00

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AAMI TIR69:2017/(R)2020

AAMI TIR69:2017/(R)2020

Active Most Recent

Risk management of radio-frequency wireless coexistence for medical devices and systems

€268.00

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