AAMI
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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/ISO 13408-7:2012/(R)2018
Aseptic processing of health care products—Part 7: Alternative processes for medical devices and combination products
01.01.2012 - PDF - Englisch - AAMI
mehr dazu174,00 € -
ANSI/AAMI/ISO 11658:2012
Cardiovascular implants and extracorporeal systems—Blood/tissue contact surface modifications for extracorporeal perfusion systems
01.01.2012 - PDF - Englisch - AAMI
mehr dazu123,00 € -
ANSI/AAMI/ISO 13022:2012
Medical products containing viable human cells—Application of risk management and requirements for processing practices
01.01.2012 - PDF - Englisch - AAMI
mehr dazu261,00 € -
ANSI/AAMI/ISO 25539-2:2012
Cardiovascular implants—Endovascular devices—Part 2: Vascular stents
01.01.2012 - PDF - Englisch - AAMI
mehr dazu303,00 € -
ANSI/AAMI/ISO 27185:2012/(R)2017
Cardiac rhythm management devices—Symbols to be used with cardiac rhythm management device labels, and information to be supplied—General requirements
01.01.2012 - PDF - Englisch - AAMI
mehr dazu261,00 € -
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
01.01.2012 - PDF - Englisch - AAMI
mehr dazu366,00 € -
ANSI/AAMI EC57:2012/(R)2020
Testing and reporting performance results of cardiac rhythm and ST segment measurement algorithms
01.01.2012 - PDF - Englisch - AAMI
mehr dazu215,00 € -
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
01.01.2011 - PDF - Englisch - AAMI
mehr dazu141,00 € -
AAMI/IEC TIR61289:2011
High frequency surgical equipment—Operation and maintenance
01.01.2011 - PDF - Englisch - AAMI
mehr dazu174,00 € -
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
01.01.2011 - PDF - Englisch - AAMI
mehr dazu174,00 € -
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
01.01.2011 - PDF - Englisch - AAMI
mehr dazu364,00 € -
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
01.01.2011 - PDF - Englisch - AAMI
mehr dazu261,00 € -
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
01.01.2011 - PDF - Englisch - AAMI
mehr dazu261,00 € -
ANSI/AAMI/ISO 25539-3:2011/(R)2015
Cardiovascular implants—Endovascular devices—Part 3: Vena Cava Filters
01.01.2011 - PDF - Englisch - AAMI
mehr dazu303,00 € -
ANSI/AAMI/ISO 10993-10:2010/(R)2014
Biological evaluation of medical devices—Part 10: Tests for irritation and skin sensitization
01.01.2010 - PDF - Englisch - AAMI
mehr dazu261,00 € -
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
01.01.2010 - PDF - Englisch - AAMI
mehr dazu303,00 € -
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
01.01.2010 - PDF - Englisch - AAMI
mehr dazu303,00 € -
ANSI/AAMI/IEC 80001-1:2010
Application of risk management for IT Networks incorporating medical devices—Part 1: Roles, responsibilities and activities.
01.01.2010 - PDF - Englisch - AAMI
mehr dazu261,00 € -
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
01.01.2010 - PDF - Englisch - AAMI
mehr dazu141,00 € -
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
01.01.2010 - PDF - Englisch - AAMI
mehr dazu261,00 € -
AAMI TIR18:2010
Guidance on electromagnetic compatibility of medical devices in healthcare facilities
01.01.2010 - PDF - Englisch - AAMI
mehr dazu261,00 € -
AAMI TIR39:2009/(R)2022
Guidance on selecting a microbial challenge and inoculation sites for sterilization validation of medical devices
01.01.2009 - PDF - Englisch - AAMI
mehr dazu141,00 € -
AAMI/IEC TIR80002-1:2009
Medical device software—Part 1: Guidance on the application of ISO 14971 to medical device software
01.01.2009 - PDF - Englisch - AAMI
mehr dazu261,00 € -
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
01.01.2009 - PDF - Englisch - AAMI
mehr dazu261,00 € -
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
01.01.2009 - PDF - Englisch - AAMI
mehr dazu303,00 € -
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
01.01.2009 - PDF - Englisch - AAMI
mehr dazu215,00 € -
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
01.01.2009 - PDF - Englisch - AAMI
mehr dazu245,00 € -
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
01.01.2009 - PDF - Englisch - AAMI
mehr dazu215,00 € -
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
01.01.2009 - PDF - Englisch - AAMI
mehr dazu174,00 € -
ANSI/AAMI/ISO 10993-5:2009/(R)2022
Biological evaluation of medical devices—Part 5: Tests for in vitro cytotoxicity
01.01.2009 - PDF - Englisch - AAMI
mehr dazu174,00 € -
ANSI/AAMI/ISO 10993-9:2009/(R)2014
Biological evaluation of medical devices—Part 9: Framework for identification and quantification of potential degradation products
01.01.2009 - PDF - Englisch - AAMI
mehr dazu141,00 € -
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
01.01.2009 - PDF - Englisch - AAMI
mehr dazu261,00 € -
459,00 € -
AAMI/IEC TIR62296:2009
Considerations of Unaddressed Safety Aspects in the Second Edition of IEC 60601-1 and Proposals for New Requirements
01.01.2009 - PDF - Englisch - AAMI
mehr dazu261,00 € -
AAMI TIR31:2008
Process challenge devices/test packs for use in health care facilities
01.01.2008 - PDF - Englisch - AAMI
mehr dazu215,00 € -
ANSI/AAMI ST41:2008/(R)2018
Ethylene oxide sterilization in health care facilities: Safety and effectiveness
01.01.2008 - PDF - Englisch - AAMI
mehr dazu319,00 € -
ANSI/AAMI ST65:2008/(R)2018
Processing of reusable surgical textiles for use in health care facilities
01.01.2008 - PDF - Englisch - AAMI
mehr dazu261,00 € -
ANSI/AAMI/ISO 10993-7:2008/(R)2012
Biological evaluation of medical devices—Part 7: Ethylene oxide sterilization residuals
01.01.2008 - PDF - Englisch - AAMI
mehr dazu261,00 € -
ANSI/AAMI/ISO 14708-4:2008/(R)2011
Implants for surgery—Active implantable medical devices—Part 4: Implantable infusion pumps
01.01.2008 - PDF - Englisch - AAMI
mehr dazu245,00 € -
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)
01.01.2008 - PDF - Englisch - AAMI
mehr dazu261,00 € -
ANSI/AAMI/ISO 15882:2008/(R)2013
Sterilization of health care products—Chemical indicators—Guidance for selection, use and interpretation of results
01.01.2008 - PDF - Englisch - AAMI
mehr dazu215,00 € -
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
01.01.2007 - PDF - Englisch - AAMI
mehr dazu174,00 € -
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
01.01.2007 - PDF - Englisch - AAMI
mehr dazu215,00 € -
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
01.01.2007 - PDF - Englisch - AAMI
mehr dazu174,00 € -
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
01.01.2007 - PDF - Englisch - AAMI
mehr dazu174,00 € -
ANSI/AAMI/ISO 81060-1:2007/(R)2013
Non invasive sphygmomanometers—Part 1: Requirements and test methods for nonautomated measurement type
01.01.2007 - PDF - Englisch - AAMI
mehr dazu245,00 € -
ANSI/AAMI/ISO 10993-2:2006/(R)2014
Biological evaluation of medical devices—Part 2: Animal welfare requirements
01.01.2006 - PDF - Englisch - AAMI
mehr dazu141,00 € -
ANSI/AAMI BE83:2006/(R)2011
Biological evaluation of medical devices—Part 18: Chemical characterization of materials
01.01.2006 - PDF - Englisch - AAMI
mehr dazu141,00 € -
303,00 € -
261,00 € -
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
01.01.2006 - PDF - Englisch - AAMI
mehr dazu261,00 € -
ANSI/AAMI/ISO 13408-3:2006/(R)2015
Aseptic processing of health care products—Part 3: Lyophilization
01.01.2006 - PDF - Englisch - AAMI
mehr dazu141,00 € -
ANSI/AAMI/ISO 13408-5:2006/(R)2015
Aseptic processing of health care products—Part 5: Sterilization in place
01.01.2006 - PDF - Englisch - AAMI
mehr dazu141,00 € -
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
01.01.2006 - PDF - Englisch - AAMI
mehr dazu245,00 € -
AAMI/ISO TIR10993-20:2006/(R)2021
Biological evaluation of medical devices—Part 20: Principles and methods for immunotoxicology testing of medical devices
01.01.2006 - PDF - Englisch - AAMI
mehr dazu174,00 € -
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
01.01.2006 - PDF - Englisch - AAMI
mehr dazu261,00 € -
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
01.01.2006 - PDF - Englisch - AAMI
mehr dazu902,00 € -
AAMI TIR11:2005/(R)2021
Selection and use of protective apparel and surgical drapes in health care facilities
01.01.2005 - PDF - Englisch - AAMI
mehr dazu215,00 € -
ANSI/AAMI/ISO 13408-4:2005/(R)2014
Aseptic processing of health care products—Part 4: Clean-in-place technologies
01.01.2005 - PDF - Englisch - AAMI
mehr dazu141,00 € -
ANSI/AAMI/ISO 13408-6:2005/(R)2013 & A1:2013
Aseptic processing of health care products—Part 6: Isolator systems (Includes Amendment 1)
01.01.2005 - PDF - Englisch - AAMI
mehr dazu141,00 € -
ANSI/AAMI ES60601-1:2005/(R)2012/A2:2021
Medical electrical equipment—Part 1: General requirements for basic safety and essential performance, Amendment 2
01.01.2005 - PDF - Englisch - AAMI
mehr dazu261,00 € -
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
01.01.2005 - PDF - Englisch - AAMI
mehr dazu1.106,00 € -
ANSI/AAMI ST40:2004/(R)2018
Table-top dry heat (heated air) sterilization and sterility assurance in health care facilities
01.01.2004 - PDF - Englisch - AAMI
mehr dazu245,00 € -
174,00 € -
ANSI/AAMI/ISO 10993-17:2002/(R)2012
Biological evaluation of medical devices—Part 17: Establishment of allowable limits for leachable substances
01.01.2002 - PDF - Englisch - AAMI
mehr dazu174,00 € -
ANSI/AAMI/ISO 10993-14:2001/(R)2019
Biological evaluation of medical devices—Part 14: Identification and quantification of degradation products from ceramics
01.01.2001 - PDF - Englisch - AAMI
mehr dazu123,00 € -
141,00 € -
215,00 € -
AAMI TIR24:1999/(R)2019
Acquisition and use of physiologic waveform databases for testing of medical devices
01.01.1999 - PDF - Englisch - AAMI
mehr dazu245,00 € -
ANSI/AAMI ST24:1999/(R)2018
Automatic, general purpose ethylene oxide sterilizers and ethylene oxide sterilant sources intended for use in health care facilities
01.01.1999 - PDF - Englisch - AAMI
mehr dazu174,00 € -
141,00 € -
AAMI TIR9:1992/(R)2019
Evaluation of clinical systems for invasive blood pressure monitoring
01.01.1992 - PDF - Englisch - AAMI
mehr dazu261,00 €
