Association for the Advancement of Medical Instrumentation (AAMI)

Association for the Advancement of Medical Instrumentation (AAMI)
ANSI/AAMI/ISO 5840-1:2022

ANSI/AAMI/ISO 5840-1:2022

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Cardiovascular implants—Cardiac valve prostheses—Part 1: General requirements

€311.00

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ANSI/AAMI/ISO 5840-2:2022

ANSI/AAMI/ISO 5840-2:2022

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Cardiovascular implants—Cardiac valve prostheses—Part 2: Surgically implanted heart valve substitutes

€268.00

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ANSI/AAMI/ISO 5840-3:2022

ANSI/AAMI/ISO 5840-3:2022

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Cardiovascular implants—Cardiac valve prostheses—Part 3: Heart valve substitutes implanted by transcatheter techniques

€268.00

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ANSI/AAMI/ISO 15223-1:2022

ANSI/AAMI/ISO 15223-1:2022

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Medical devices—Symbols to be used with information to be supplied by the manufacturer— Part 1: General requirements

€251.00

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ANSI/AAMI SW96:2023

ANSI/AAMI SW96:2023

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Standard for medical device security—Security risk management for device manufacturers

€268.00

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AAMI TIR45:2023 Redline

AAMI TIR45:2023 Redline

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Guidance on the use of AGILE practices in the development of medical device software

€311.00

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ANSI/AAMI/IEC 60601-1-8:2006 & A1:2013 & A2:2021 Redline

ANSI/AAMI/IEC 60601-1-8:2006 & A1:2013 & A2:2021 Redline

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Medical electrical equipment—Part 1-8: General requirements for basic safety and essential performance—Collateral standard: General requirements, test and guidance for alarm systems in medical electrical equipment and medical electrical systems

€1,989.00

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ANSI/AAMI/IEC 60601-1-2:2014 & A1:2021 Redline

ANSI/AAMI/IEC 60601-1-2:2014 & A1:2021 Redline

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Medical electrical equipment—Part 1-2: General requirements for basic safety and essential performance—Collateral standard: Electromagnetic disturbances—Requirements and tests Consolidated Text, Redline Version

€1,476.00

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ANSI/AAMI ES60601-1:2005/(R)2012 & A1:2012 & A2:2021 Redline

ANSI/AAMI ES60601-1:2005/(R)2012 & A1:2012 & A2:2021 Redline

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Medical electrical equipment—Part 1: General requirements for basic safety and essential performance

€2,644.00

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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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ANSI/AAMI/IEC 60601-1-12:2016 & A1:2021 Redline

ANSI/AAMI/IEC 60601-1-12:2016 & A1:2021 Redline

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Medical electrical equipment—Part 1-12: General requirements for basic safety and essential performance— Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in emergency medical services envi

€732.00

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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 TIR48:2024

AAMI TIR48:2024

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Quality Management System (QMS) guidance on compliance with FDA's Final Rule on combination products

€251.00

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ANSI/AAMI ST24:2024

ANSI/AAMI ST24:2024

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General-purpose ethylene oxide sterilizers with automated process control and ethylene oxide sterilant sources intended for use in health care facilities

€221.00

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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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