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 TIR66:2017/(R)2025

AAMI TIR66:2017/(R)2025

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Guidance for the creation of physiologic data and waveform databases to demonstrate reasonable assurance of the safety and effectiveness of alarm system algorithms

€221.00

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AAMI TIR71:2017/(R)2020

AAMI TIR71:2017/(R)2020

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Guidance for logging of alarm system data

€144.00

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ANSI/AAMI/ISO 8637-1:2017

ANSI/AAMI/ISO 8637-1:2017

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Extracorporeal systems for blood purification—Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators

€221.00

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AAMI RT2:2017

AAMI RT2:2017

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Radiation therapy readiness check

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

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ANSI/AAMI ST79:2017/(R)2022 w/ AMDs A1:2020, A2:2020, A3:2020, A4:2020

ANSI/AAMI ST79:2017/(R)2022 w/ AMDs A1:2020, A2:2020, A3:2020, A4:2020

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Comprehensive guide to steam sterilization and sterility assurance in health care facilities

€450.00

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AAMI TIR17:2017/(R)2023

AAMI TIR17:2017/(R)2023

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Compatibility of materials subject to sterilization

€311.00

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AAMI TIR57:2016/(R)2023

AAMI TIR57:2016/(R)2023

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Principles for medical device security—Risk management

€311.00

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AAMI/ISO 13485:2016

AAMI/ISO 13485:2016

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Medical Devices: A Practical Guide

€174.00

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ANSI/AAMI/ISO 7198:2016

ANSI/AAMI/ISO 7198:2016

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Cardiovascular implants—Tubular vascular prostheses

€268.00

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AAMI TIR14:2016/(R)2024

AAMI TIR14:2016/(R)2024

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Contract sterilization using ethylene oxide

€144.00

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AAMI TIR28:2016/(R)2024

AAMI TIR28:2016/(R)2024

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Product adoption and process equivalence for ethylene oxide sterilization

€144.00

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AAMI TIR15:2016/(R)2024

AAMI TIR15:2016/(R)2024

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Physical aspects of ethylene oxide sterilization

€178.00

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AAMI TIR35:2016/(R)2021

AAMI TIR35:2016/(R)2021

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Sterilization of health care products—Radiation sterilization—Product adoption and alternative sampling plans for verification dose experiments and sterilization dose audits

€221.00

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AAMI/IEC TIR80001-2-8:2016

AAMI/IEC TIR80001-2-8:2016

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Application of risk management for IT networks incorporating medical devices—Part 2-8: Application guidance—Guidance on standards for establishing the security capabilities identified in IEC 80001-2-2

€430.00

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AAMI/IEC TIR80002-3:2016

AAMI/IEC TIR80002-3:2016

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Medical Device Software—Part 3: Process reference model of medical device software life cycle processes (IEC 62304)

€269.00

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