Association for the Advancement of Medical Instrumentation (AAMI)

Association for the Advancement of Medical Instrumentation (AAMI)
ANSI/AAMI/IEC 80601-2-58:2024

ANSI/AAMI/IEC 80601-2-58:2024

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Medical electrical equipment—Part 2-58: Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery

€334.00

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ANSI/AAMI EQ110:2024 Corrigendum 1

ANSI/AAMI EQ110:2024 Corrigendum 1

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Healthcare technology management (HTM) educational programs Corrigendum 1

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

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AAMI CR515:2025

AAMI CR515:2025

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Cybersecurity considerations unique to machine learning–enabled medical devices

€178.00

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ANSI/AAMI/ISO 10993-2:2006/(R)2014

ANSI/AAMI/ISO 10993-2:2006/(R)2014

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Biological evaluation of medical devices—Part 2: Animal welfare requirements

€144.00

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AAMI HIT1000-3(PS):2019

AAMI HIT1000-3(PS):2019

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Safety and effectiveness of health IT software and systems—Part 3: Application of risk management

€21.00

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AAMI TIR102:2019

AAMI TIR102:2019

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U.S. FDA 21 CFR mapping to the applicable regulatory requirement references in ISO 13485:2016 Quality Management Systems

€311.00

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AAMI TIR21:2017/(R)2025

AAMI TIR21:2017/(R)2025

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Systems used to forecast remaining pacemaker battery service life

€268.00

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AAMI TIR23:1999/(R)2019

AAMI TIR23:1999/(R)2019

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Signal averaging

€221.00

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AAMI TIR24:1999/(R)2025

AAMI TIR24:1999/(R)2025

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Acquisition and use of physiologic waveform databases for testing of medical devices

€251.00

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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 TIR65:2015/(R)2022

AAMI TIR65:2015/(R)2022

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Sustainability of medical devices—Elements of a responsible product life cycle

€251.00

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AAMI TIR38:2019

AAMI TIR38:2019

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Medical device safety assurance case guidance

€268.00

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AAMI TIR69:2017/(R)2020

AAMI TIR69:2017/(R)2020

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Risk management of radio-frequency wireless coexistence for medical devices and systems

€268.00

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AAMI TIR72:2017/(R)2025

AAMI TIR72:2017/(R)2025

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Dialysis fluid chemical composition

€144.00

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AAMI TIR41:2011/(R)2025

AAMI TIR41:2011/(R)2025

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Active implantable medical devices—Guidance for designation of left ventricle and implantable cardioverter defibrillator lead connectors and pulse generator connector cavities for implantable pacemakers and implantable cardioverter defibrillators

€144.00

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