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 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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ANSI/AAMI BP22:1994/(R)2016

ANSI/AAMI BP22:1994/(R)2016

Active Most Recent

Blood Pressure Transducers

€144.00

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AAMI TIR9:1992/(R)2019

AAMI TIR9:1992/(R)2019

Active Most Recent

Evaluation of clinical systems for invasive blood pressure monitoring

€268.00

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AAMI CR34971:2022 [HISTORICAL]

AAMI CR34971:2022 [HISTORICAL]

Withdrawn Most Recent

Guidance on the Application of ISO 14971 to Artificial Intelligence and Machine Learning

€221.00

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AAMI TIR16:2017/(R)2020 [HISTORICAL]

AAMI TIR16:2017/(R)2020 [HISTORICAL]

Superseded Historical

Microbiological aspects of ethylene oxide sterilization

€178.00

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ANSI/AAMI/ISO 17664:2017 [HISTORICAL]

ANSI/AAMI/ISO 17664:2017 [HISTORICAL]

Withdrawn Most Recent

Processing of health care products—Information to be provided by the medical device manufacturer for the processing of medical devices.

€221.00

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ANSI/AAMI/ISO 15223-1:2016 [HISTORICAL]

ANSI/AAMI/ISO 15223-1:2016 [HISTORICAL]

Withdrawn Most Recent

Medical devices—Symbols to be used with medical device labels, labelling and information to be supplied—Part 1: General requirements

€178.00

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AAMI TIR74:2016/(R)2021 [HISTORICAL]

AAMI TIR74:2016/(R)2021 [HISTORICAL]

Withdrawn Most Recent

Change summary for ISO 11135:2014, Sterilization of health care products—Ethylene oxide—Requirements for the development, validation and routine control of a sterilization process for medical devices

€144.00

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ANSI/AAMI/ISO 5840-1:2015 [HISTORICAL]

ANSI/AAMI/ISO 5840-1:2015 [HISTORICAL]

Superseded Historical

Cardiovascular implants—Cardiac valve prostheses—Part 1: General requirements

€268.00

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ANSI/AAMI/ISO 5840-2:2015 [HISTORICAL]

ANSI/AAMI/ISO 5840-2:2015 [HISTORICAL]

Superseded Historical

Cardiovascular implants—Cardiac valve prostheses—Part 2: Surgically implanted heart valve substitutes

€268.00

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AAMI TIR48:2015/(R)2021

AAMI TIR48:2015/(R)2021

Superseded Historical

Quality Management System (QMS) Recommendations on the Application of the U.S. FDA—s CGMP Final Rule on Combination Products

€178.00

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AAMI/ISO TIR16775:2014 [HISTORICAL]

AAMI/ISO TIR16775:2014 [HISTORICAL]

Superseded Historical

Packaging for terminally sterilized medical devices—Guidance on the application of ISO 11607-1 and ISO 11607-2

€311.00

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ANSI/AAMI/IEC 80601-2-58:2014 [HISTORICAL]

ANSI/AAMI/IEC 80601-2-58:2014 [HISTORICAL]

Superseded Historical

Medical electrical equipment—Part 2-58: Particular requirements for basic safety and essential performance of lens removal and vitrectomy devices for ophthalmic surgery

€178.00

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ANSI/AAMI/IEC 80601-2-58:2014/A1:2016 [HISTORICAL]

ANSI/AAMI/IEC 80601-2-58:2014/A1:2016 [HISTORICAL]

Superseded Historical

Amendment 1 to Medical Electrical Equipment Part 2-58

€144.00

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AAMI TIR34:2014/(R)2021 [HISTORICAL]

AAMI TIR34:2014/(R)2021 [HISTORICAL]

Superseded Historical

Water for the reprocessing of medical devices

€268.00

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