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 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

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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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ANSI/AAMI/ISO 10993-16:2020/(R)2022

ANSI/AAMI/ISO 10993-16:2020/(R)2022

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Biological evaluation of medical devices—Part 16: Toxicokinetic study design for degradation products and leachables

€144.00

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ANSI/AAMI/ISO 14155:2020

ANSI/AAMI/ISO 14155:2020

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Clinical investigation of medical devices for human subjects—Good clinical practice

€311.00

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AAMI/ISO TIR10993-19:2020

AAMI/ISO TIR10993-19:2020

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Biological evaluation of medical devices—Part 19: Physico-chemical, morphological and topographical characterization of materials

€178.00

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AAMI TIR97:2019/(R)2023

AAMI TIR97:2019/(R)2023

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Principles for medical device security—Postmarket risk management for device manufacturers

€268.00

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ANSI/AAMI ST72:2019

ANSI/AAMI ST72:2019

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Bacterial endotoxins—Test methods, routine monitoring, and alternatives to batch testing

€268.00

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ANSI/AAMI/ISO 11737-2:2019

ANSI/AAMI/ISO 11737-2:2019

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Sterilization of medical devices—Microbiological methods—Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process

€178.00

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