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.
ANSI/AAMI/IEC 80601-2-58:2024

ANSI/AAMI/IEC 80601-2-58:2024

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

€334.00

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AAMI TIR17:2024

AAMI TIR17:2024

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Compatibility of materials subject to sterilization

€311.00

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AAMI TIR34971:2023

AAMI TIR34971:2023

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Application of ISO 14971 to machine learning in artificial intelligence—Guide

€221.00

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AAMI TIR45:2023

AAMI TIR45:2023

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

€311.00

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ANSI/AAMI/ISO 10993-13-2010/(R)2019:2023

ANSI/AAMI/ISO 10993-13-2010/(R)2019:2023

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Biological evaluation of medical devices—Part 13: Identification and quantification of degradation products from polymeric devices

€129.00

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ANSI/AAMI SW96:2023

ANSI/AAMI SW96:2023

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Standard for medical device security—Security risk management for device manufacturers

€268.00

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AAMI TIR45:2023 Redline

AAMI TIR45:2023 Redline

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

€311.00

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ANSI/AAMI/ISO 11138-8:2023

ANSI/AAMI/ISO 11138-8:2023

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Sterilization of health care products—Biological indicators—Part 8: Method for validation of a reduced incubation item for a biological indicator

€144.00

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AAMI/ISO TIR16775:2023

AAMI/ISO TIR16775:2023

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

€373.00

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ANSI/AAMI ST108:2023

ANSI/AAMI ST108:2023

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Water for the processing of medical devices

€311.00

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AAMI/ISO TIR21387:2023

AAMI/ISO TIR21387:2023

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Sterilization of health care products—Guidance on the requirements for the validation and routine processing of ethylene oxide sterilization processes using parametric release

€178.00

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AAMI TIR16:2023

AAMI TIR16:2023

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Microbiological aspects of ethylene oxide sterilization

€268.00

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ANSI/AAMI/ISO 13408-1:2023

ANSI/AAMI/ISO 13408-1:2023

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Aseptic processing of health care products—Part 1: General requirements

€311.00

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AAMI TIR104:2022

AAMI TIR104:2022

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Guidance on transferring health care products between radiation sterilization sources

€221.00

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ANSI/AAMI ST98:2022

ANSI/AAMI ST98:2022

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Cleaning validation of health care products—Requirements for development and validation of a cleaning process for medical devices

€251.00

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