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 HA60601-1-11:2015 & A1:2021 Redline

ANSI/AAMI HA60601-1-11:2015 & A1:2021 Redline

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Medical electrical equipment—Part 1-11: General requirements for basic safety and essential performance— Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment

€853.00

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AAMI TIR62:2014/(R)2025

AAMI TIR62:2014/(R)2025

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Generating reports for the purpose of submitting defibrillation waveform data for evaluation

€126.00

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AAMI TIR52:2014/(R)2022

AAMI TIR52:2014/(R)2022

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Environmental monitoring for terminally sterilized healthcare products

€126.00

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AAMI TIR55:2014/(R)2017

AAMI TIR55:2014/(R)2017

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Human factors engineering for processing medical devices

€178.00

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AAMI/IEC TIR80001-2-5:2014

AAMI/IEC TIR80001-2-5:2014

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Application of risk management for IT-networks incorporating medical devices—Part 2-5: Application guidance—Guidance for distributed alarm systems

€334.00

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AAMI TIR60:2014/(R)2019

AAMI TIR60:2014/(R)2019

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Common mode rejection in ECG monitoring

€144.00

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AAMI TIR61:2014/(R)2025

AAMI TIR61:2014/(R)2025

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Generating reports for human factors design validation results for external cardiac defibrillator

€144.00

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AAMI/IEC TIR80001-2-7:2014

AAMI/IEC TIR80001-2-7:2014

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Application of risk management for IT-networks incorporating medical devices—Part 2-7: Application guidance—Guidance for Healthcare Delivery Organizations (HDOs) on how to self-assess their conformance with IEC 80001-1

€311.00

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AAMI/ISO TIR17665-3:2014/(R)2016

AAMI/ISO TIR17665-3:2014/(R)2016

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Sterilization of health care products—Moist Heat—Guidance on the designation of a medical product to a product family and processing category for steam sterilization

€268.00

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ANSI/AAMI/ISO 10993-3:2014/(R)2023

ANSI/AAMI/ISO 10993-3:2014/(R)2023

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Biological evaluation of medical devices—Part 3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity

€268.00

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ANSI/AAMI/ISO 11135:2014

ANSI/AAMI/ISO 11135:2014

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Sterilization of health care products—Ethylene oxide—Requirements for development, validation and routine control of a sterilization process for medical devices

€311.00

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ANSI/AAMI/ISO 11135:2014/A1:2018

ANSI/AAMI/ISO 11135:2014/A1:2018

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Sterilization of health-care products— Ethylene oxide—Requirements for the development, validation and routine control of a sterilization process for medical devices—Amendment 1: Revision of Annex E, Single batch release

€289.00

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ANSI/AAMI/ISO 11140-1:2014/(R)2025

ANSI/AAMI/ISO 11140-1:2014/(R)2025

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Sterilization of health care products—Chemical indicators—Part 1: General requirements

€204.00

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ANSI/AAMI/ISO 14708-1:2014

ANSI/AAMI/ISO 14708-1:2014

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Implants for surgery—Active implantable medical devices—Part 1: General requirements for safety, marking and for information to be provided by the manufacturer

€268.00

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ANSI/AAMI/ISO TIR37137:2014

ANSI/AAMI/ISO TIR37137:2014

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Cardiovascular biological evaluation of medical devices—Guidance for absorbable implants

€144.00

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