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/ISO 23500-3:2019

ANSI/AAMI/ISO 23500-3:2019

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Preparation and quality management of fluids for haemodialysis and related therapies—Part 3: Water for haemodialysis and related therapies

€178.00

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ANSI/AAMI/ISO 23500-4:2019

ANSI/AAMI/ISO 23500-4:2019

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Preparation and quality management of fluids for haemodialysis and related therapies—Part 4: Concentrates for haemodialysis and related therapies

€221.00

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ANSI/AAMI/ISO 23500-5:2019

ANSI/AAMI/ISO 23500-5:2019

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Preparation and quality management of fluids for haemodialysis and related therapies—Part 5: Quality of dialysis fluid for haemodialysis and related therapies

€178.00

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ANSI/AAMI/ISO 81060-2:2019

ANSI/AAMI/ISO 81060-2:2019

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Non-invasive sphygmomanometers—Clinical investigation of intermittent automated measurement type

€251.00

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AAMI CR500:2019

AAMI CR500:2019

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Basic Introduction to the IEC 60601 Series

€178.00

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ANSI/AAMI/ISO 10993-15:2019

ANSI/AAMI/ISO 10993-15:2019

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Biological evaluation of medical devices—Part 15: Identification and quantification of degradation products from metals and alloys

€144.00

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ANSI/AAMI/ISO 11607-1:2019/A1:2023

ANSI/AAMI/ISO 11607-1:2019/A1:2023

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Packaging for terminally sterilized medical devices—Part 1: Requirements for materials, sterile barrier systems and packaging systems Amendment 1: Application of risk management

€178.00

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ANSI/AAMI/ISO 11607-2:2019/A1:2023

ANSI/AAMI/ISO 11607-2:2019/A1:2023

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Packaging for terminally sterilized medical devices—Part 2: Validation requirements for forming, sealing and assembly processes Amendment 1: Application of risk management

€144.00

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ANSI/AAMI/ISO 11737-1:2018

ANSI/AAMI/ISO 11737-1:2018

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Sterilization of health care products—Microbiological methods—Part 1: Determination of a population of microorganisms on products

€268.00

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AAMI TIR40:2018/(R)2022

AAMI TIR40:2018/(R)2022

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Sterilization of health care products—Radiation—Guidance on dose setting utilizing a Modified Method 2

€178.00

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AAMI TIR77:2018/(R)2025

AAMI TIR77:2018/(R)2025

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Sorbent-based regenerative hemodialysis systems

€178.00

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AAMI/ISO TIR10974:2018

AAMI/ISO TIR10974:2018

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Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device

€333.00

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AAMI/ISO TIR21900:2018

AAMI/ISO TIR21900:2018

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Guidance for uncertainty analysis regarding the application of ISO/TS 10974

€144.00

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ANSI/AAMI SW91:2018

ANSI/AAMI SW91:2018

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Classification of defects in health software

€268.00

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ANSI/AAMI/ISO 10993-1:2018

ANSI/AAMI/ISO 10993-1:2018

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Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process

€268.00

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