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 TIR18:2010

AAMI TIR18:2010

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Guidance on electromagnetic compatibility of medical devices in healthcare facilities

€268.00

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AAMI TIR39:2009/(R)2022

AAMI TIR39:2009/(R)2022

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Guidance on selecting a microbial challenge and inoculation sites for sterilization validation of medical devices

€144.00

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AAMI/IEC TIR80002-1:2009

AAMI/IEC TIR80002-1:2009

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Medical device software—Part 1: Guidance on the application of ISO 14971 to medical device software

€488.00

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AAMI/ISO TIR17665-2:2009/(R)2016

AAMI/ISO TIR17665-2:2009/(R)2016

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Sterilization of health care products—Moist Heat—Part 2: Guidance on the application of AAMI/ISO 17665-1

€268.00

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ANSI/AAMI ST15883-1:2009/(R)2023 & A1:2014 & A2:2012

ANSI/AAMI ST15883-1:2009/(R)2023 & A1:2014 & A2:2012

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(Consolidated Text) (ISO 15883-1:2006, MOD) Washer-disinfectors—Part 1: General requirements, terms and definitions and tests

€311.00

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ANSI/AAMI/IEC 60601-2-19:2009/(R)2014 & A1:2016

ANSI/AAMI/IEC 60601-2-19:2009/(R)2014 & A1:2016

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Medical Electrical Equipment—Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators

€360.00

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ANSI/AAMI/IEC 60601-2-20:2009/(R)2014 & A1:2016

ANSI/AAMI/IEC 60601-2-20:2009/(R)2014 & A1:2016

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Medical Electrical Equipment—Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators

€430.00

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ANSI/AAMI/IEC 60601-2-21:2009/(R)2014 & A1:2016

ANSI/AAMI/IEC 60601-2-21:2009/(R)2014 & A1:2016

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Medical Electrical Equipment—Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers

€360.00

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ANSI/AAMI/IEC 60601-2-50:2009/(R)2014 & A1:2016

ANSI/AAMI/IEC 60601-2-50:2009/(R)2014 & A1:2016

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Medical electrical equipment—Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment

€282.00

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ANSI/AAMI/ISO 10993-5:2009/(R)2022

ANSI/AAMI/ISO 10993-5:2009/(R)2022

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Biological evaluation of medical devices—Part 5: Tests for in vitro cytotoxicity

€230.00

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ANSI/AAMI/ISO 10993-9:2009/(R)2014

ANSI/AAMI/ISO 10993-9:2009/(R)2014

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Biological evaluation of medical devices—Part 9: Framework for identification and quantification of potential degradation products

€144.00

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ANSI/AAMI/ISO 14937:2009/(R)2013

ANSI/AAMI/ISO 14937:2009/(R)2013

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Sterilization of health care products—General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices

€268.00

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AAMI/IEC TIR62296:2009

AAMI/IEC TIR62296:2009

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Considerations of Unaddressed Safety Aspects in the Second Edition of IEC 60601-1 and Proposals for New Requirements

€488.00

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AAMI TIR31:2008

AAMI TIR31:2008

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Process challenge devices/test packs for use in health care facilities

€221.00

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ANSI/AAMI ST65:2008/(R)2018

ANSI/AAMI ST65:2008/(R)2018

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Processing of reusable surgical textiles for use in health care facilities

€268.00

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