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 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Withdrawn Most Recent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 CR500:2019

AAMI CR500:2019

Active Most Recent

Basic Introduction to the IEC 60601 Series

€178.00

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AAMI CR510:2021

AAMI CR510:2021

Active Most Recent

Appropriate Use of Public Cloud Computing for Quality Systems and Medical Devices

€126.00

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AAMI CR513:2024

AAMI CR513:2024

Active Most Recent

Guidance on radiation validation and routine maintenance for single-use systems used for pharmaceutical and biopharmaceutical manufacturing

€144.00

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AAMI CR515:2025

AAMI CR515:2025

Active Most Recent

Cybersecurity considerations unique to machine learning–enabled medical devices

€205.00

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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 HIT1000-4(PS):2020

AAMI HIT1000-4(PS):2020

Active Most Recent

Safety and effectiveness of health IT software and systems—Part 4: Application of human factors engineering

€21.00

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AAMI RT2:2017

AAMI RT2:2017

Active Most Recent

Radiation therapy readiness check

This product is not for sale, please contact us for more information

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AAMI RT3:2020

AAMI RT3:2020

Active Most Recent

Radiation therapy machine characterization

This product is not for sale, please contact us for more information

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AAMI TIR100:2021

AAMI TIR100:2021

Active Most Recent

End-to-end microbiological quality and sterility assurance

€178.00

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AAMI TIR101:2021

AAMI TIR101:2021

Active Most Recent

Fluid delivery performance testing for infusion pumps

€268.00

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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 TIR104:2022

AAMI TIR104:2022

Active Most Recent

Guidance on transferring health care products between radiation sterilization sources

€221.00

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AAMI TIR105:2020

AAMI TIR105:2020

Active Most Recent

Risk management guidance for combination products

€251.00

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AAMI TIR106:2024

AAMI TIR106:2024

Active Most Recent

Microbiological methods—Understanding and use of product bioburden data

€221.00

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