AAMI
AAMI (Association for the Advancement of Medical Instrumentation) is a non-profit organization that accredits medical device manufacturers and suppliers. AAMI's accreditation program evaluates compliance with quality and performance standards for medical devices. It also provides guidelines and recommendations for the design, testing, and labeling of medical devices.
By using AAMI-accredited devices, healthcare providers can ensure that their patients receive safe and effective care.
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ANSI/AAMI ST15883-3:2012/(R)2023
Washer-disinfectors—Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers
1/1/2012 - PDF - English -
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AAMI TIR44:2012
Non-invasive blood pressure motion artifact—Testing and evaluation of NIBP device performance in the presence of motion artifact
1/1/2012 - PDF - English -
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AAMI/IEC TIR80001-2-4:2012
Application of risk management for IT-networks incorporating medical devices—Part 2-4: General implementation guidance for healthcare delivery organizations.
1/1/2012 - PDF - English -
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ANSI/AAMI/ISO 13022:2012
Medical products containing viable human cells—Application of risk management and requirements for processing practices
1/1/2012 - PDF - English -
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AAMI/ISO TIR23810:2012/(R)2015
Cardiovascular implants and artificial organs—Checklist for preoperative extracorporeal circulation equipment setup
1/1/2012 - PDF - English -
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ANSI/AAMI/IEC TIR62348:2012
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
1/1/2012 - PDF - English -
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AAMI/IEC TIR80001-2-3:2012
Application of risk management for IT-networks incorporating medical devices—Part 2-3: Guidance for wireless networks
1/1/2012 - PDF - English -
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ANSI/AAMI/ISO 14160:2011/(R)2016
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
1/1/2011 - PDF - English -
Learn More€261.00 -
€174.00
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ANSI/AAMI/IEC 60601-2-27:2011/(R)2016
Medical electrical equipment—Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment
1/1/2011 - PDF - English -
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ANSI/AAMI/ISO 25539-3:2011/(R)2015
Cardiovascular implants—Endovascular devices—Part 3: Vena Cava Filters
1/1/2011 - PDF - English -
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AAMI/ISO TIR22442-4:2011/(R)2016
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
1/1/2011 - PDF - English -
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AAMI TIR41:2011/(R)2020
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
1/1/2011 - PDF - English -
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ANSI/AAMI/IEC 60601-2-25:2011/(R)2016
Medical electrical equipment—Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs
1/1/2011 - PDF - English -
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ANSI/AAMI/ISO 20857:2010/(R)2015
Sterilization of health care products—Dry heat: Requirements for the development, validation and routine control of a sterilization process for medical devices
1/1/2010 - PDF - English -
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ANSI/AAMI/IEC 80001-1:2010
Application of risk management for IT Networks incorporating medical devices—Part 1: Roles, responsibilities and activities.
1/1/2010 - PDF - English -
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ANSI/AAMI/ISO 10993-10:2010/(R)2014
Biological evaluation of medical devices—Part 10: Tests for irritation and skin sensitization
1/1/2010 - PDF - English -
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AAMI TIR18:2010
Guidance on electromagnetic compatibility of medical devices in healthcare facilities
1/1/2010 - PDF - English -
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ANSI/AAMI/ISO 15223-2:2010/(R)2016
Medical devices—Symbols to be used with medical device labels, labeling and information to be supplied—Part 2: Symbol development, selection and validation
1/1/2010 - PDF - English -
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ANSI/AAMI/IEC 60601-2-4:2010/A1:2018 (Redline Version)
Medical electrical equipment—Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators, including Amendment 1
1/1/2010 - PDF - English -
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ANSI/AAMI/IEC 60601-2-4:2010/A1:2018 (Consolidated Text)
Medical electrical equipment—Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators, including Amendment 1
1/1/2010 - PDF - English -
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ANSI/AAMI/IEC 60601-2-19:2009/(R)2014 & A1:2016
Medical Electrical Equipment—Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators
1/1/2009 - PDF - English -
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ANSI/AAMI/IEC 60601-2-21:2009/(R)2014 & A1:2016
Medical Electrical Equipment—Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers
1/1/2009 - PDF - English -
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ANSI/AAMI/IEC 60601-2-50:2009/(R)2014 & A1:2016
Medical electrical equipment—Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment
1/1/2009 - PDF - English -
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ANSI/AAMI/IEC 60601-2-20:2009/(R)2014 & A1:2016
Medical Electrical Equipment—Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators
1/1/2009 - PDF - English -
Learn More€245.00 -
€459.00
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ANSI/AAMI/ISO 10993-9:2009/(R)2014
Biological evaluation of medical devices—Part 9: Framework for identification and quantification of potential degradation products
1/1/2009 - PDF - English -
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ANSI/AAMI/ISO 14937:2009/(R)2013
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
1/1/2009 - PDF - English -
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AAMI TIR39:2009/(R)2022
Guidance on selecting a microbial challenge and inoculation sites for sterilization validation of medical devices
1/1/2009 - PDF - English -
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ANSI/AAMI/ISO 10993-5:2009/(R)2022
Biological evaluation of medical devices—Part 5: Tests for in vitro cytotoxicity
1/1/2009 - PDF - English -
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AAMI/IEC TIR80002-1:2009
Medical device software—Part 1: Guidance on the application of ISO 14971 to medical device software
1/1/2009 - PDF - English -
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AAMI/ISO TIR17665-2:2009/(R)2016
Sterilization of health care products—Moist Heat—Part 2: Guidance on the application of AAMI/ISO 17665-1
1/1/2009 - PDF - English -
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AAMI/IEC TIR62296:2009
Considerations of Unaddressed Safety Aspects in the Second Edition of IEC 60601-1 and Proposals for New Requirements
1/1/2009 - PDF - English -
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ANSI/AAMI ST15883-1:2009/(R)2023 & A1:2014 & A2:2012
(Consolidated Text) (ISO 15883-1:2006, MOD) Washer-disinfectors—Part 1: General requirements, terms and definitions and tests
1/1/2009 - PDF - English -
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AAMI TIR31:2008
Process challenge devices/test packs for use in health care facilities
1/1/2008 - PDF - English -
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ANSI/AAMI ST65:2008/(R)2018
Processing of reusable surgical textiles for use in health care facilities
1/1/2008 - PDF - English -
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ANSI/AAMI/ISO 10993-7:2008/(R)2012
Biological evaluation of medical devices—Part 7: Ethylene oxide sterilization residuals
1/1/2008 - PDF - English -
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ANSI/AAMI/ISO 13408-1:2008/(R)2017 & A1:2013/(R)2017
Aseptic processing of health care products—Part 1: General requirements (includes Amendment 1)
1/1/2008 - PDF - English -
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ANSI/AAMI/ISO 15882:2008/(R)2013
Sterilization of health care products—Chemical indicators—Guidance for selection, use and interpretation of results
1/1/2008 - PDF - English -
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ANSI/AAMI ST41:2008/(R)2018
Ethylene oxide sterilization in health care facilities: Safety and effectiveness
1/1/2008 - PDF - English -
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ANSI/AAMI/ISO 14708-4:2008/(R)2011
Implants for surgery—Active implantable medical devices—Part 4: Implantable infusion pumps
1/1/2008 - PDF - English -
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ANSI/AAMI/ISO 81060-1:2007/(R)2013
Non invasive sphygmomanometers—Part 1: Requirements and test methods for nonautomated measurement type
1/1/2007 - PDF - English -
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ANSI/AAMI/ISO 11140-3:2007/(R)2015
Sterilization of health care products—Chemical indicators—Part 3: Class 2 indicator systems for use in the Bowie and Dick steam penetration test
1/1/2007 - PDF - English -
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ANSI/AAMI/ISO 11140-5:2007/(R)2015
Sterilization of health care products—Chemical indicators—Part 5: Class 2 indicators for Bowie and Dick air removal test sheets and packs
1/1/2007 - PDF - English -
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ANSI/AAMI/ISO 11140-4:2007/(R)2015
Sterilization of health care products—Chemical indicators—Part 4: Class 2 indicators as an alternative to Bowie and Dick test for detection of steam penetration
1/1/2007 - PDF - English -
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ANSI/AAMI/ISO 22442-3:2007/(R)2016
Medical devices utilizing animal tissues and their derivatives—Part 3: Validation of the elimination and/or inactivation of viruses and transimissible spongiform encephalopathy (TSE) agents
1/1/2007 - PDF - English -
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ANSI/AAMI/IEC 60601-1-8:2006 & A1:2013 & A2:2021 Redline
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
1/1/2006 - PDF - English -
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ANSI/AAMI/ISO 10993-2:2006/(R)2014
Biological evaluation of medical devices—Part 2: Animal welfare requirements
1/1/2006 - PDF - English -
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ANSI/AAMI/ISO 13408-3:2006/(R)2015
Aseptic processing of health care products—Part 3: Lyophilization
1/1/2006 - PDF - English -
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ANSI/AAMI/ISO 13408-5:2006/(R)2015
Aseptic processing of health care products—Part 5: Sterilization in place
1/1/2006 - PDF - English -
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€261.00
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ANSI/AAMI/ISO 11137-1:2006/(R)2015 & A1:2013 & A2:2019
Sterilization of health care products—Radiation—Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices
1/1/2006 - PDF - English -
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AAMI/ISO TIR10993-20:2006/(R)2021
Biological evaluation of medical devices—Part 20: Principles and methods for immunotoxicology testing of medical devices
1/1/2006 - PDF - English -
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ANSI/AAMI/IEC 60601-1-8:2006/A2:2021
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
1/1/2006 - PDF - English -
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ANSI/AAMI/ISO 17665-1:2006/(R)2013
Sterilization of health care products—Moist heat—Part 1 Requirements for the development, validation and routine control of a sterilization process for medical devices
1/1/2006 - PDF - English -
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€303.00
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ANSI/AAMI BE83:2006/(R)2011
Biological evaluation of medical devices—Part 18: Chemical characterization of materials
1/1/2006 - PDF - English -
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ANSI/AAMI/ISO 13408-6:2005/(R)2013 & A1:2013
Aseptic processing of health care products—Part 6: Isolator systems (Includes Amendment 1)
1/1/2005 - PDF - English -
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AAMI TIR11:2005/(R)2021
Selection and use of protective apparel and surgical drapes in health care facilities
1/1/2005 - PDF - English -
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ANSI/AAMI/ISO 13408-4:2005/(R)2014
Aseptic processing of health care products—Part 4: Clean-in-place technologies
1/1/2005 - PDF - English -
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ANSI/AAMI ES60601-1:2005/(R)2012/A2:2021
Medical electrical equipment—Part 1: General requirements for basic safety and essential performance, Amendment 2
1/1/2005 - PDF - English -
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ANSI/AAMI ES60601-1:2005/(R)2012 & A1:2012 & A2:2021 Redline
Medical electrical equipment—Part 1: General requirements for basic safety and essential performance
1/1/2005 - PDF - English -
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€174.00
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ANSI/AAMI ST40:2004/(R)2018
Table-top dry heat (heated air) sterilization and sterility assurance in health care facilities
1/1/2004 - PDF - English -
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ANSI/AAMI/ISO 10993-17:2002/(R)2012
Biological evaluation of medical devices—Part 17: Establishment of allowable limits for leachable substances
1/1/2002 - PDF - English -
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ANSI/AAMI/ISO 10993-14:2001/(R)2019
Biological evaluation of medical devices—Part 14: Identification and quantification of degradation products from ceramics
1/1/2001 - PDF - English -
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€141.00
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ANSI/AAMI ST24:1999/(R)2018
Automatic, general purpose ethylene oxide sterilizers and ethylene oxide sterilant sources intended for use in health care facilities
1/1/1999 - PDF - English -
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€215.00
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AAMI TIR24:1999/(R)2019
Acquisition and use of physiologic waveform databases for testing of medical devices
1/1/1999 - PDF - English -
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€141.00
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AAMI TIR9:1992/(R)2019
Evaluation of clinical systems for invasive blood pressure monitoring
1/1/1992 - PDF - English -
Learn More€261.00