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 PC76:2021

ANSI/AAMI PC76:2021

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Active implantable medical devices— Requirements and test protocols for safety of patients with pacemakers and ICDs exposed to magnetic resonance imaging

€311.00

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AAMI TIR43:2021/(R)2025

AAMI TIR43:2021/(R)2025

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Ultrapure dialysis fluid for hemodialysis and related therapies

€251.00

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AAMI TIR76:2021

AAMI TIR76:2021

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Sterilization of health care products—Radiation—Substantiation of a selected sterilization dose at a specified sterility assurance level: Method VDmax SD-S

€251.00

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AAMI TIR100:2021

AAMI TIR100:2021

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End-to-end microbiological quality and sterility assurance

€178.00

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ANSI/AAMI/ISO 20417:2021

ANSI/AAMI/ISO 20417:2021

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Medical devices—Information to be supplied by the manufacturer

€311.00

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AAMI TIR105:2020

AAMI TIR105:2020

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Risk management guidance for combination products

€251.00

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AAMI TIR12:2020/(R)2023

AAMI TIR12:2020/(R)2023

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Designing, testing, and labeling medical devices intended for processing by health care facilities: A guide for device manufacturers

€268.00

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AAMI/ISO TIR20416:2020

AAMI/ISO TIR20416:2020

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Medical devices—Post-market surveillance for manufacturers

€251.00

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AAMI/ISO TIR24971:2020

AAMI/ISO TIR24971:2020

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Medical devices—Guidance on the application of ISO 14971

€311.00

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ANSI/AAMI RD47:2020

ANSI/AAMI RD47:2020

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Reprocessing of hemodialyzers

€268.00

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ANSI/AAMI MP80601-2-49:2020 (IEC 80601-2-49:2020, MOD)

ANSI/AAMI MP80601-2-49:2020 (IEC 80601-2-49:2020, MOD)

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Medical electrical equipment—Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitors

€379.00

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AAMI HIT1000-4(PS):2020

AAMI HIT1000-4(PS):2020

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

€21.00

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AAMI RT3:2020

AAMI RT3:2020

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Radiation therapy machine characterization

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

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ANSI/AAMI/IEC 80601-2-77:2020

ANSI/AAMI/IEC 80601-2-77:2020

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Medical electrical equipment—Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment

€421.00

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ANSI/AAMI/IEC 80601-2-78:2020

ANSI/AAMI/IEC 80601-2-78:2020

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Medical electrical equipment—Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation

€482.00

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