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/IEC TIR62348:2012

ANSI/AAMI/IEC TIR62348:2012

Active Most Recent

Assessment of the impact of the most significant changes in Amendment 1 to IEC 60601-1:2005 and mapping of the clauses of IEC 60601-1:2005 to the previous edition

€520.00

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ANSI/AAMI EC57:2012/(R)2020

ANSI/AAMI EC57:2012/(R)2020

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Testing and reporting performance results of cardiac rhythm and ST segment measurement algorithms

€221.00

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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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AAMI/IEC TIR61289:2011

AAMI/IEC TIR61289:2011

Active Most Recent

High frequency surgical equipment—Operation and maintenance

€205.00

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AAMI/ISO TIR22442-4:2011/(R)2016

AAMI/ISO TIR22442-4:2011/(R)2016

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Medical devices utilizing animal tissues and their derivatives—Part 4: Principles for elimination and/or inactivation of transmissible spongiform encephalopathy (TSE) agents and validation assays for those processes

€178.00

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ANSI/AAMI/IEC 60601-2-25:2011/(R)2016

ANSI/AAMI/IEC 60601-2-25:2011/(R)2016

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Medical electrical equipment—Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs

€520.00

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ANSI/AAMI/IEC 60601-2-27:2011/(R)2016

ANSI/AAMI/IEC 60601-2-27:2011/(R)2016

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Medical electrical equipment—Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment

€488.00

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ANSI/AAMI/ISO 14160:2011/(R)2016

ANSI/AAMI/ISO 14160:2011/(R)2016

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Sterilization of health care products—Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives—Requirements for characterization, development, validation and routine control of a sterilization proces

€268.00

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ANSI/AAMI/ISO 25539-3:2011/(R)2015

ANSI/AAMI/ISO 25539-3:2011/(R)2015

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Cardiovascular implants—Endovascular devices—Part 3: Vena Cava Filters

€311.00

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ANSI/AAMI/ISO 10993-10:2010/(R)2014

ANSI/AAMI/ISO 10993-10:2010/(R)2014

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Biological evaluation of medical devices—Part 10: Tests for irritation and skin sensitization

€268.00

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ANSI/AAMI/IEC 60601-2-4:2010/A1:2018 (Consolidated Text)

ANSI/AAMI/IEC 60601-2-4:2010/A1:2018 (Consolidated Text)

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Medical electrical equipment—Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators, including Amendment 1

€1,014.00

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ANSI/AAMI/IEC 60601-2-4:2010/A1:2018 (Redline Version)

ANSI/AAMI/IEC 60601-2-4:2010/A1:2018 (Redline Version)

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Medical electrical equipment—Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators, including Amendment 1

€1,014.00

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ANSI/AAMI/IEC 80001-1:2010

ANSI/AAMI/IEC 80001-1:2010

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Application of risk management for IT Networks incorporating medical devices—Part 1: Roles, responsibilities and activities.

€379.00

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ANSI/AAMI/ISO 15223-2:2010/(R)2016

ANSI/AAMI/ISO 15223-2:2010/(R)2016

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Medical devices—Symbols to be used with medical device labels, labeling and information to be supplied—Part 2: Symbol development, selection and validation

€144.00

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ANSI/AAMI/ISO 20857:2010/(R)2015

ANSI/AAMI/ISO 20857:2010/(R)2015

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

€268.00

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