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 17665-1:2006/(R)2013

ANSI/AAMI/ISO 17665-1:2006/(R)2013

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Sterilization of health care products—Moist heat—Part 1 Requirements for the development, validation and routine control of a sterilization process for medical devices

€251.00

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AAMI/ISO TIR10993-20:2006/(R)2021

AAMI/ISO TIR10993-20:2006/(R)2021

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Biological evaluation of medical devices—Part 20: Principles and methods for immunotoxicology testing of medical devices

€178.00

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ANSI/AAMI/IEC 60601-1-8:2006/A2:2021

ANSI/AAMI/IEC 60601-1-8:2006/A2:2021

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Medical Electrical Equipment—Part 1-8: General requirements for basic safety and essential performance—Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems, Amend. 2

€430.00

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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/ISO 13408-4:2005/(R)2014

ANSI/AAMI/ISO 13408-4:2005/(R)2014

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Aseptic processing of health care products—Part 4: Clean-in-place technologies

€144.00

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ANSI/AAMI/ISO 13408-6:2005/(R)2013 & A1:2013

ANSI/AAMI/ISO 13408-6:2005/(R)2013 & A1:2013

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Aseptic processing of health care products—Part 6: Isolator systems (Includes Amendment 1)

€173.00

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

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

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Medical electrical equipment—Part 1: General requirements for basic safety and essential performance, Amendment 2

€430.00

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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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AAMI TIR11:2005/(R)2026

AAMI TIR11:2005/(R)2026

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Selection and use of protective apparel and surgical drapes in health care facilities

€221.00

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ANSI/AAMI ST40:2004/(R)2018

ANSI/AAMI ST40:2004/(R)2018

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Table-top dry heat (heated air) sterilization and sterility assurance in health care facilities

€251.00

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ANSI/AAMI ST50:2004/(R)2018

ANSI/AAMI ST50:2004/(R)2018

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Dry heat (heated air) sterilizers

€178.00

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ANSI/AAMI/ISO 10993-17:2002/(R)2012

ANSI/AAMI/ISO 10993-17:2002/(R)2012

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Biological evaluation of medical devices—Part 17: Establishment of allowable limits for leachable substances

€178.00

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ANSI/AAMI/ISO 10993-14:2001/(R)2019

ANSI/AAMI/ISO 10993-14:2001/(R)2019

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Biological evaluation of medical devices—Part 14: Identification and quantification of degradation products from ceramics

€126.00

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ANSI/AAMI EC12:2000/(R)2020

ANSI/AAMI EC12:2000/(R)2020

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Disposable ECG electrodes

€144.00

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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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