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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AAMI TIR9:1992/(R)2019
Evaluation of clinical systems for invasive blood pressure monitoring
01.01.1992 - PDF - Englisch - AAMI
mehr dazu285,00 € -
153,00 € -
234,00 € -
AAMI TIR24:1999/(R)2025
Acquisition and use of physiologic waveform databases for testing of medical devices
01.01.1999 - PDF - Englisch - AAMI
mehr dazu267,00 € -
153,00 € -
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 dazu134,00 € -
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 dazu189,00 € -
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 dazu267,00 € -
189,00 € -
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 dazu234,00 € -
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 dazu153,00 € -
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 dazu153,00 € -
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 dazu285,00 € -
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 dazu1.205,00 € -
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 dazu153,00 € -
ANSI/AAMI BE83:2006/(R)2011
Biological evaluation of medical devices—Part 18: Chemical characterization of materials
01.01.2006 - PDF - Englisch - AAMI
mehr dazu153,00 € -
330,00 € -
285,00 € -
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 dazu285,00 € -
ANSI/AAMI/ISO 13408-3:2006/(R)2015
Aseptic processing of health care products—Part 3: Lyophilization
01.01.2006 - PDF - Englisch - AAMI
mehr dazu153,00 € -
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 dazu153,00 € -
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 dazu267,00 € -
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 dazu189,00 € -
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 dazu285,00 € -
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 dazu982,00 € -
ANSI/AAMI/ISO 11140-3:2007/(R)2025
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 dazu189,00 € -
ANSI/AAMI/ISO 11140-4:2007/(R)2025
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 dazu234,00 € -
ANSI/AAMI/ISO 11140-5:2007/(R)2025
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 dazu189,00 € -
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 dazu189,00 € -
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 dazu267,00 € -
AAMI TIR31:2008
Process challenge devices/test packs for use in health care facilities
01.01.2008 - PDF - Englisch - AAMI
mehr dazu234,00 € -
ANSI/AAMI ST65:2008/(R)2018
Processing of reusable surgical textiles for use in health care facilities
01.01.2008 - PDF - Englisch - AAMI
mehr dazu285,00 € -
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 dazu285,00 € -
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 dazu267,00 € -
ANSI/AAMI/ISO 15882:2008/(R)2025
Sterilization of health care products—Chemical indicators—Guidance for selection, use and interpretation of results
01.01.2008 - PDF - Englisch - AAMI
mehr dazu211,00 € -
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 dazu153,00 € -
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 dazu285,00 € -
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 dazu285,00 € -
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 dazu330,00 € -
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 dazu234,00 € -
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 dazu267,00 € -
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 dazu234,00 € -
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 dazu189,00 € -
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 dazu189,00 € -
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 dazu153,00 € -
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 dazu285,00 € -
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 dazu285,00 € -
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 dazu285,00 € -
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 dazu330,00 € -
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 dazu330,00 € -
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 dazu285,00 € -
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 dazu153,00 € -
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 dazu285,00 € -
AAMI TIR18:2010
Guidance on electromagnetic compatibility of medical devices in healthcare facilities
01.01.2010 - PDF - Englisch - AAMI
mehr dazu285,00 € -
AAMI TIR41:2011/(R)2025
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 dazu138,00 € -
AAMI/IEC TIR61289:2011
High frequency surgical equipment—Operation and maintenance
01.01.2011 - PDF - Englisch - AAMI
mehr dazu189,00 € -
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 dazu189,00 € -
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 dazu396,00 € -
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 dazu285,00 € -
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 dazu285,00 € -
ANSI/AAMI/ISO 25539-3:2011/(R)2015
Cardiovascular implants—Endovascular devices—Part 3: Vena Cava Filters
01.01.2011 - PDF - Englisch - AAMI
mehr dazu330,00 € -
AAMI TIR44:2012
Non-invasive blood pressure motion artifact—Testing and evaluation of NIBP device performance in the presence of motion artifact
01.01.2012 - PDF - Englisch - AAMI
mehr dazu189,00 € -
AAMI/IEC TIR80001-2-3:2012
Application of risk management for IT-networks incorporating medical devices—Part 2-3: Guidance for wireless networks
01.01.2012 - PDF - Englisch - AAMI
mehr dazu267,00 € -
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.
01.01.2012 - PDF - Englisch - AAMI
mehr dazu189,00 € -
AAMI/ISO TIR23810:2012/(R)2015
Cardiovascular implants and artificial organs—Checklist for preoperative extracorporeal circulation equipment setup
01.01.2012 - PDF - Englisch - AAMI
mehr dazu234,00 € -
ANSI/AAMI PB70:2012 Red-Line
Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities
01.01.2012 - PDF - Englisch - AAMI
mehr dazu285,00 € -
ANSI/AAMI ST15883-3:2012/(R)2023
Washer-disinfectors—Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers
01.01.2012 - PDF - Englisch - AAMI
mehr dazu153,00 € -
ANSI/AAMI/ISO 10993-12:2012
Biological evaluation of medical devices—Part 12: Sample preparation and reference materials
01.01.2012 - PDF - Englisch - AAMI
mehr dazu189,00 € -
ANSI/AAMI/IEC 60601-2-47:2012/(R)2016
Medical electrical equipment—Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems
01.01.2012 - PDF - Englisch - AAMI
mehr dazu285,00 € -
ANSI/AAMI/IEC TIR80001-2-1:2012
Application of risk management for IT-networks incorporating medical devices—Part 2-1: Step by step risk management of medical IT-networks, Practical applications and examples.
01.01.2012 - PDF - Englisch - AAMI
mehr dazu285,00 € -
ANSI/AAMI/IEC TIR80001-2-2:2012
Application of risk management for IT-networks incorporating medical devices—Part 2-2: Guidance for the disclosure and communication of medical device security needs, risks and controls
01.01.2012 - PDF - Englisch - AAMI
mehr dazu285,00 € -
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 dazu189,00 € -
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 dazu134,00 € -
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 dazu285,00 € -
ANSI/AAMI/ISO 25539-2:2012
Cardiovascular implants—Endovascular devices—Part 2: Vascular stents
01.01.2012 - PDF - Englisch - AAMI
mehr dazu330,00 € -
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 dazu285,00 € -
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 dazu398,00 € -
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 dazu234,00 € -
153,00 € -
ANSI/AAMI ST15883-2:2013/(R)2023 (ISO 15883-2:2006 MOD)
Washer-disinfectors—Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc.
01.01.2013 - PDF - Englisch - AAMI
mehr dazu153,00 € -
ANSI/AAMI ST77:2013/(R)2018
Containment devices for reusable medical device sterilization
01.01.2013 - PDF - Englisch - AAMI
mehr dazu189,00 € -
ANSI/AAMI/ISO 11137-2:2013/(R)2019
Sterilization of health care products—Radiation—Part 2: Establishing the sterilization dose
01.01.2013 - PDF - Englisch - AAMI
mehr dazu285,00 € -
234,00 € -
AAMI TIR49:2013/(R)2020
Design of training and instructional materials for medical devices used in non-clinical environments
01.01.2013 - PDF - Englisch - AAMI
mehr dazu267,00 € -
AAMI TIR56:2013/(R)2024
Guidance for the development, validation and routine control of an ethylene oxide sterilization process utilizing flexible bag systems for the sterilization of medical devices
01.01.2013 - PDF - Englisch - AAMI
mehr dazu189,00 € -
153,00 € -
AAMI TIR62:2014/(R)2025
Generating reports for the purpose of submitting defibrillation waveform data for evaluation
01.01.2014 - PDF - Englisch - AAMI
mehr dazu134,00 € -
AAMI TIR52:2014/(R)2022
Environmental monitoring for terminally sterilized healthcare products
01.01.2014 - PDF - Englisch - AAMI
mehr dazu134,00 € -
AAMI TIR55:2014/(R)2017
Human factors engineering for processing medical devices
01.01.2014 - PDF - Englisch - AAMI
mehr dazu189,00 € -
AAMI/IEC TIR80001-2-5:2014
Application of risk management for IT-networks incorporating medical devices—Part 2-5: Application guidance—Guidance for distributed alarm systems
01.01.2014 - PDF - Englisch - AAMI
mehr dazu234,00 € -
153,00 € -
AAMI TIR61:2014/(R)2025
Generating reports for human factors design validation results for external cardiac defibrillator
01.01.2014 - PDF - Englisch - AAMI
mehr dazu153,00 € -
AAMI/IEC TIR80001-2-7:2014
Application of risk management for IT-networks incorporating medical devices—Part 2-7: Application guidance—Guidance for Healthcare Delivery Organizations (HDOs) on how to self-assess their conformance with IEC 80001-1
01.01.2014 - PDF - Englisch - AAMI
mehr dazu330,00 € -
AAMI/ISO TIR17665-3:2014/(R)2016
Sterilization of health care products—Moist Heat—Guidance on the designation of a medical product to a product family and processing category for steam sterilization
01.01.2014 - PDF - Englisch - AAMI
mehr dazu285,00 € -
ANSI/AAMI/ISO 10993-3:2014/(R)2023
Biological evaluation of medical devices—Part 3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity
01.01.2014 - PDF - Englisch - AAMI
mehr dazu285,00 € -
ANSI/AAMI/ISO 11135:2014
Sterilization of health care products—Ethylene oxide—Requirements for development, validation and routine control of a sterilization process for medical devices
01.01.2014 - PDF - Englisch - AAMI
mehr dazu330,00 € -
ANSI/AAMI/ISO 11135:2014/A1:2018
Sterilization of health-care products— Ethylene oxide—Requirements for the development, validation and routine control of a sterilization process for medical devices—Amendment 1: Revision of Annex E, Single batch release
01.01.2014 - PDF - Englisch - AAMI
mehr dazu153,00 € -
ANSI/AAMI/ISO 11140-1:2014/(R)2025
Sterilization of health care products—Chemical indicators—Part 1: General requirements
01.01.2014 - PDF - Englisch - AAMI
mehr dazu189,00 € -
ANSI/AAMI/ISO 14708-1:2014
Implants for surgery—Active implantable medical devices—Part 1: General requirements for safety, marking and for information to be provided by the manufacturer
01.01.2014 - PDF - Englisch - AAMI
mehr dazu285,00 € -
ANSI/AAMI/ISO TIR37137:2014
Cardiovascular biological evaluation of medical devices—Guidance for absorbable implants
01.01.2014 - PDF - Englisch - AAMI
mehr dazu153,00 € -
234,00 € -
AAMI TIR51:2014/(R)2017
Human factors engineering—Guidance for contextual inquiry
01.01.2014 - PDF - Englisch - AAMI
mehr dazu153,00 € -
ANSI/AAMI/IEC 60601-1-2:2014
Medical electrical equipment—Part 1-2: General requirements for basic safety and essential performance—Collateral standard: Electromagnetic disturbances—Requirements and tests
01.01.2014 - PDF - Englisch - AAMI
mehr dazu396,00 € -
AAMI/ISO TIR80001-2-6:2014
Application of risk management for IT-networks incorporating medical—Application guidance—Part 2-6: Guidance for responsibility agreements
01.01.2014 - PDF - Englisch - AAMI
mehr dazu153,00 € -
AAMI TIR63:2014/(R)2023
Management of loaned critical and semi-critical medical devices that require sterilization or high-level disinfection
01.01.2014 - PDF - Englisch - AAMI
mehr dazu153,00 € -
ANSI/AAMI/IEC 60601-1-2:2014/A1:2021
Medical electrical equipment—Part 1-2: General requirements for basic safety and essential performance—Collateral standard: Electromagnetic disturbances—Requirements and tests, Amendment 1
01.01.2014 - PDF - Englisch - AAMI
mehr dazu267,00 € -
ANSI/AAMI/IEC 60601-1-2:2014 & A1:2021 Redline
Medical electrical equipment—Part 1-2: General requirements for basic safety and essential performance—Collateral standard: Electromagnetic disturbances—Requirements and tests Consolidated Text, Redline Version
01.01.2014 - PDF - Englisch - AAMI
mehr dazu330,00 € -
AAMI TIR65:2015/(R)2022
Sustainability of medical devices—Elements of a responsible product life cycle
01.01.2015 - PDF - Englisch - AAMI
mehr dazu267,00 € -
AAMI/IEC TIR60878:2015
Graphic symbols for electrical equipment in medical practice
01.01.2015 - PDF - Englisch - AAMI
mehr dazu510,00 € -
ANSI/AAMI EQ89:2015/(R)2023
Guidance for the use of medical equipment maintenance strategies and procedures
01.01.2015 - PDF - Englisch - AAMI
mehr dazu153,00 € -
ANSI/AAMI/ISO 80369-20:2015
Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods
01.01.2015 - PDF - Englisch - AAMI
mehr dazu267,00 € -
ANSI/AAMI/IEC TIR62354:2015
General testing procedures for medical electrical equipment
01.01.2015 - PDF - Englisch - AAMI
mehr dazu537,00 € -
ANSI/AAMI HA60601-1-11:2015 (IEC 60601-1-11:2015, MOD)
MEDICAL ELECTRICAL EQUIPMENT—Part 1-11: General requirements for basic safety and essential performance—Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.
01.01.2015 - PDF - Englisch - AAMI
mehr dazu396,00 € -
ANSI/AAMI/IEC 62366-1:2015/(R)2021+AMD1:2020 (Consolidated Text)
Medical devices—Part 1: Application of usability engineering to medical devices + Amendment 1
01.01.2015 - PDF - Englisch - AAMI
mehr dazu285,00 € -
ANSI/AAMI HA60601-1-11:2015/A1:2021
Medical electrical equipment—Part 1-11: General requirements for basic safety and essential performance—Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment, Amendment 1
01.01.2015 - PDF - Englisch - AAMI
mehr dazu134,00 € -
ANSI/AAMI HA60601-1-11:2015 & A1:2021 Redline
Medical electrical equipment—Part 1-11: General requirements for basic safety and essential performance— Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
01.01.2015 - PDF - Englisch - AAMI
mehr dazu396,00 € -
AAMI TIR35:2016/(R)2021
Sterilization of health care products—Radiation sterilization—Product adoption and alternative sampling plans for verification dose experiments and sterilization dose audits
01.01.2016 - PDF - Englisch - AAMI
mehr dazu234,00 € -
330,00 € -
AAMI/IEC TIR80001-2-8:2016
Application of risk management for IT networks incorporating medical devices—Part 2-8: Application guidance—Guidance on standards for establishing the security capabilities identified in IEC 80001-2-2
01.01.2016 - PDF - Englisch - AAMI
mehr dazu285,00 € -
AAMI/IEC TIR80002-3:2016
Medical Device Software—Part 3: Process reference model of medical device software life cycle processes (IEC 62304)
01.01.2016 - PDF - Englisch - AAMI
mehr dazu234,00 € -
234,00 € -
ANSI/AAMI/ISO 10993-6:2016
Biological evaluation of medical devices—Part 6: Tests for local effects after implantation
01.01.2016 - PDF - Englisch - AAMI
mehr dazu189,00 € -
ANSI/AAMI/ISO 13485:2016/(R)2019
Medical devices—Quality management systems—Requirements for regulatory purposes
01.01.2016 - PDF - Englisch - AAMI
mehr dazu285,00 € -
ANSI/AAMI/ISO 15674:2016
Cardiovascular implants and artificial organs—Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags
01.01.2016 - PDF - Englisch - AAMI
mehr dazu134,00 € -
ANSI/AAMI/ISO 15675:2016
Cardiovascular implants and artificial organs—Cardiopulmonary bypass systems—Arterial blood line filters
01.01.2016 - PDF - Englisch - AAMI
mehr dazu134,00 € -
ANSI/AAMI/ISO 15676:2016
Cardiovascular implants and artificial organs—Requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO)
01.01.2016 - PDF - Englisch - AAMI
mehr dazu153,00 € -
![ANSI/AAMI/ISO 16142-1:2016 [HISTORICAL]](https://www.normadoc.com/media/catalog/product/cache/3/small_image/95x95/9df78eab33525d08d6e5fb8d27136e95/a/1/a152e000006j63yqaa.png)
ANSI/AAMI/ISO 16142-1:2016 [HISTORICAL]
Medical devices—Recognized essential principles of safety and performance of medical devices—Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
01.01.2016 - PDF - Englisch - AAMI
mehr dazu285,00 € -
ANSI/AAMI/ISO 18241:2016
Cardiovascular implants and extracorporeal systems—Cardiopulmonary bypass systems—Venous bubble traps
01.01.2016 - PDF - Englisch - AAMI
mehr dazu189,00 € -
ANSI/AAMI/ISO 18242:2016
Cardiovascular implants and extracorporeal systems—Centrifugal blood pumps
01.01.2016 - PDF - Englisch - AAMI
mehr dazu153,00 € -
ANSI/AAMI/ISO 22442-1:2016
Medical devices utilizing animal tissues and their derivatives—Part 1: Application of risk management
01.01.2016 - PDF - Englisch - AAMI
mehr dazu234,00 € -
ANSI/AAMI/ISO 22442-2:2016
Medical devices utilizing animal tissues and their derivatives—Part 2: Controls on sourcing, collection and handling
01.01.2016 - PDF - Englisch - AAMI
mehr dazu153,00 € -
ANSI/AAMI/ISO 80369-3:2016
Small-bore connectors for liquids and gases in healthcare applications—Part 3: connectors for enteral applications
01.01.2016 - PDF - Englisch - AAMI
mehr dazu285,00 € -
ANSI/AAMI/ISO 80369-3:2016/A1:2019
Small-bore connectors for liquids and gases in healthcare applications—Part 3: Connectors for enteral applications—Amendment 1
01.01.2016 - PDF - Englisch - AAMI
mehr dazu153,00 € -
ANSI/AAMI/ISO 80369-5:2016
Small-bore connectors for liquids and gases in healthcare applications—Part 5: Connectors for limb cuff inflation applications
01.01.2016 - PDF - Englisch - AAMI
mehr dazu234,00 € -
ANSI/AAMI/ISO 80369-6:2016
Small-bore connectors for liquids and gases in healthcare applications—Part 6: Connectors for neuraxial applications
01.01.2016 - PDF - Englisch - AAMI
mehr dazu285,00 € -
ANSI/AAMI/ISO 80369-7:2016
Small-bore connectors for liquids and gases in healthcare applications—Part 7: Connectors for intravascular or hypodermic applications
01.01.2016 - PDF - Englisch - AAMI
mehr dazu285,00 € -
ANSI/AAMI/ISO TIR19024:2016
Evaluation of CPB devices relative to their capabilities of reducing the transmission of gaseous microemboli (GME) to a patient during cardiopulmonary bypass
01.01.2016 - PDF - Englisch - AAMI
mehr dazu189,00 € -
285,00 € -
ANSI/AAMI/ISO 7199:2016
Cardiovascular implants and artificial organs—Blood-gas exchangers (oxygenators)
01.01.2016 - PDF - Englisch - AAMI
mehr dazu153,00 € -
AAMI/IEC TIR62366-2:2016
Medical devices—Part 2: Guidance on the application of usability engineering to medical devices
01.01.2016 - PDF - Englisch - AAMI
mehr dazu330,00 € -
ANSI/AAMI/IEC 60601-1-12:2016
Medical electrical equipment—Part 1-12: General requirements for basic safety and essential performance—Collateral standard: Requirements for medical electrical equipment & medical electrical systems intended for use in emergency medical services environ.
01.01.2016 - PDF - Englisch - AAMI
mehr dazu285,00 € -
153,00 € -
AAMI TIR28:2016/(R)2024
Product adoption and process equivalence for ethylene oxide sterilization
01.01.2016 - PDF - Englisch - AAMI
mehr dazu153,00 € -
189,00 € -
ANSI/AAMI/IEC 60601-1-12:2016/A1:2021
Medical electrical equipment—Part 1-12: General requirements—Collateral standard: Requirements for medical electrical equipment and medical electrical systems intended for use in emergency medical services environment—Amendment 1
01.01.2016 - PDF - Englisch - AAMI
mehr dazu134,00 € -
ANSI/AAMI/IEC 60601-1-12:2016 & A1:2021 Redline
Medical electrical equipment—Part 1-12: General requirements for basic safety and essential performance— Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in emergency medical services envi
01.01.2016 - PDF - Englisch - AAMI
mehr dazu285,00 € -
AAMI TIR21:2017/(R)2025
Systems used to forecast remaining pacemaker battery service life
01.01.2017 - PDF - Englisch - AAMI
mehr dazu257,00 € -
AAMI TIR69:2017/(R)2020
Risk management of radio-frequency wireless coexistence for medical devices and systems
01.01.2017 - PDF - Englisch - AAMI
mehr dazu285,00 € -
153,00 € -
ANSI/AAMI CI86:2017/(R)2025
Cochlear implant systems: Requirements for safety, functional verification, labeling and reliability reporting
01.01.2017 - PDF - Englisch - AAMI
mehr dazu330,00 € -
AAMI/ISO TIR15499:2017
Biological evaluation of medical devices—Guidance on the conduct of biological evaluation within a risk management process
01.01.2017 - PDF - Englisch - AAMI
mehr dazu189,00 € -
AAMI/ISO TIR80002-2:2017
Medical device software—Part 2: Validation of software for medical device quality systems
01.01.2017 - PDF - Englisch - AAMI
mehr dazu330,00 € -
ANSI/AAMI ST90:2017/(R)2024
Processing of health care products—Quality management systems for processing in health care facilities
01.01.2017 - PDF - Englisch - AAMI
mehr dazu267,00 € -
ANSI/AAMI/ISO 10993-11:2017/(R)2023
Biological evaluation of medical devices—Part 11: Tests for systemic toxicity
01.01.2017 - PDF - Englisch - AAMI
mehr dazu234,00 € -
ANSI/AAMI/IEC 60601-2-2:2017
Medical electrical equipment—Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
01.01.2017 - PDF - Englisch - AAMI
mehr dazu285,00 € -
ANSI/AAMI/ISO 10993-4:2017
Biological evaluation of medical devices—Part 4: Selection of tests for interactions with blood
01.01.2017 - PDF - Englisch - AAMI
mehr dazu285,00 € -
ANSI/AAMI/ISO 11137-3:2017/(R)2023
Sterilization of health care products—Radiation—Part 3: Guidance on dosimetric aspects of development, validation and routine control
01.01.2017 - PDF - Englisch - AAMI
mehr dazu153,00 € -
ANSI/AAMI/ISO 11138-1:2017/(R)2024
Sterilization of health care products—Biological indicators—Part 1: General requirements
01.01.2017 - PDF - Englisch - AAMI
mehr dazu285,00 € -
ANSI/AAMI/ISO 11138-2:2017/(R)2024
Sterilization of health care products—Biological indicators—Part 2: Biological indicators for ethylene oxide sterilization processes
01.01.2017 - PDF - Englisch - AAMI
mehr dazu134,00 € -
ANSI/AAMI/ISO 11138-3:2017/(R)2024
Sterilization of health care products—Biological indicators—Part 3: Biological indicators for moist heat sterilization processes
01.01.2017 - PDF - Englisch - AAMI
mehr dazu134,00 € -
ANSI/AAMI/ISO 11138-4:2017/(R)2024
Sterilization of health care products—Biological indicators—Part 4: Biological indicators for dry heat sterilization processes
01.01.2017 - PDF - Englisch - AAMI
mehr dazu134,00 € -
ANSI/AAMI/ISO 11138-5:2017/(R)2024
Sterilization of health care products—Biological indicators—Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes
01.01.2017 - PDF - Englisch - AAMI
mehr dazu134,00 € -
ANSI/AAMI/ISO 14708-3:2017
Implants for surgery—Active implantable medical devices—Part 3: Implantable neurostimulators
01.01.2017 - PDF - Englisch - AAMI
mehr dazu267,00 € -
![ANSI/AAMI/ISO 16142-2:2017 [HISTORICAL]](https://www.normadoc.com/media/catalog/product/cache/3/small_image/95x95/9df78eab33525d08d6e5fb8d27136e95/a/1/a152e000006j63zqaa.png)
ANSI/AAMI/ISO 16142-2:2017 [HISTORICAL]
Medical devices—Recognized essential principles of safety and performance of medical devices—Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards
01.01.2017 - PDF - Englisch - AAMI
mehr dazu285,00 € -
ANSI/AAMI/ISO 25539-1:2017
Cardiovascular implants— Endovascular devices—Part 1: Endovascular prostheses
01.01.2017 - PDF - Englisch - AAMI
mehr dazu234,00 € -
211,00 € -
AAMI TIR66:2017/(R)2025
Guidance for the creation of physiologic data and waveform databases to demonstrate reasonable assurance of the safety and effectiveness of alarm system algorithms
01.01.2017 - PDF - Englisch - AAMI
mehr dazu234,00 € -
153,00 € -
ANSI/AAMI/ISO 8637-1:2017
Extracorporeal systems for blood purification—Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
01.01.2017 - PDF - Englisch - AAMI
mehr dazu234,00 € -
ANSI/AAMI ST79:2017/(R)2022 w/ AMDs A1:2020, A2:2020, A3:2020, A4:2020
Comprehensive guide to steam sterilization and sterility assurance in health care facilities
01.01.2017 - PDF - Englisch - AAMI
mehr dazu478,00 € -
AAMI TIR40:2018/(R)2022
Sterilization of health care products—Radiation—Guidance on dose setting utilizing a Modified Method 2
01.01.2018 - PDF - Englisch - AAMI
mehr dazu189,00 € -
189,00 € -
AAMI/ISO TIR10974:2018
Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device
01.01.2018 - PDF - Englisch - AAMI
mehr dazu354,00 € -
AAMI/ISO TIR21900:2018
Guidance for uncertainty analysis regarding the application of ISO/TS 10974
01.01.2018 - PDF - Englisch - AAMI
mehr dazu153,00 € -
285,00 € -
ANSI/AAMI/ISO 10993-1:2018
Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process
01.01.2018 - PDF - Englisch - AAMI
mehr dazu285,00 € -
ANSI/AAMI/ISO 11737-1:2018
Sterilization of health care products—Microbiological methods—Part 1: Determination of a population of microorganisms on products
01.01.2018 - PDF - Englisch - AAMI
mehr dazu285,00 € -
ANSI/AAMI/ISO 13408-2:2018
Aseptic processing of health care products—Part 2: Sterilizing filtration
01.01.2018 - PDF - Englisch - AAMI
mehr dazu153,00 € -
ANSI/AAMI/ISO 80369-1:2018
Small-bore connectors for liquids and gases in healthcare applications—Part 1: General requirements
01.01.2018 - PDF - Englisch - AAMI
mehr dazu153,00 € -
ANSI/AAMI/IEC 80601-2-30:2018
Medical electrical equipment—Part 2-30: Particular requirements for basic safety and essential performance of automated type non-invasive sphygmomanometers
01.01.2018 - PDF - Englisch - AAMI
mehr dazu285,00 € -
ANSI/AAMI/ISO 8637-3:2018
Extracorporeal systems for blood purification—Part 3: Plasmafilters
01.01.2018 - PDF - Englisch - AAMI
mehr dazu189,00 € -
ANSI/AAMI/ISO 8637-2:2018
Extracorporeal systems for blood purification— Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
01.01.2018 - PDF - Englisch - AAMI
mehr dazu189,00 € -
ANSI/AAMI/IEC 60601-2-16:2018
Medical electrical equipment—Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
01.01.2018 - PDF - Englisch - AAMI
mehr dazu285,00 € -
ANSI/AAMI/IEC 60601-2-39:2018
Medical electrical equipment—Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment
01.01.2018 - PDF - Englisch - AAMI
mehr dazu234,00 € -
AAMI TIR67:2018/(R)2022
Promoting safe practices pertaining to the use of sterilant and disinfectant chemicals in health care facilities
01.01.2018 - PDF - Englisch - AAMI
mehr dazu285,00 € -
AAMI TIR68:2018/(R)2022
Low and intermediate-level disinfection in healthcare settings for medical devices and patient care equipment and sterile processing environmental surfaces
01.01.2018 - PDF - Englisch - AAMI
mehr dazu234,00 € -
ANSI/AAMI/ISO 11737-1:2018/A1:2021
Sterilization of health care products—Microbiological methods—Part 1: Determination of a population of microorganisms on products—AMENDMENT 1
01.01.2018 - PDF - Englisch - AAMI
mehr dazu153,00 € -
AAMI TIR97:2019/(R)2023
Principles for medical device security—Postmarket risk management for device manufacturers
01.01.2019 - PDF - Englisch - AAMI
mehr dazu285,00 € -
AAMI HIT1000-3(PS):2019
Safety and effectiveness of health IT software and systems—Part 3: Application of risk management
01.01.2019 - PDF - Englisch - AAMI
mehr dazu23,00 € -
AAMI TIR102:2019
U.S. FDA 21 CFR mapping to the applicable regulatory requirement references in ISO 13485:2016 Quality Management Systems
01.01.2019 - PDF - Englisch - AAMI
mehr dazu330,00 € -
285,00 € -
AAMI TIR75:2019
Factors to consider when multi-vendor devices interact via an electronic interface: Practical applications and examples
01.01.2019 - PDF - Englisch - AAMI
mehr dazu234,00 € -
ANSI/AAMI EQ93:2019/(R)2025
Medical equipment management—Vocabulary used in medical equipment programs
01.01.2019 - PDF - Englisch - AAMI
mehr dazu134,00 € -
ANSI/AAMI 2700-1:2019
Medical Devices and Medical Systems—Essential safety and performance requirements for equipment comprising the patient-centric integrated clinical environment (ICE)—Part 1: General requirements and conceptual model
01.01.2019 - PDF - Englisch - AAMI
mehr dazu234,00 € -
ANSI/AAMI ST67:2019
Sterilization of health care products—Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled —sterile—
01.01.2019 - PDF - Englisch - AAMI
mehr dazu153,00 € -
ANSI/AAMI ST72:2019
Bacterial endotoxins—Test methods, routine monitoring, and alternatives to batch testing
01.01.2019 - PDF - Englisch - AAMI
mehr dazu285,00 € -
ANSI/AAMI/ISO 11138-7:2019
Sterilization of health care products—Biological indicators—Part 7: Guidance for the selection, use and interpretation of results
01.01.2019 - PDF - Englisch - AAMI
mehr dazu285,00 € -
ANSI/AAMI/ISO 14117:2019/(R)2025
Active implantable medical devices—Electromagnetic compatibility—EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices
01.01.2019 - PDF - Englisch - AAMI
mehr dazu330,00 € -
ANSI/AAMI/ISO 11607-1:2019
Packaging for terminally sterilized medical devices—Part 1: Requirements for materials, sterile barrier systems and packaging systems
01.01.2019 - PDF - Englisch - AAMI
mehr dazu189,00 € -
ANSI/AAMI/ISO 11607-2:2019
Packaging for terminally sterilized medical devices—Part 2: Validation requirements for forming, sealing and assembly processes
01.01.2019 - PDF - Englisch - AAMI
mehr dazu153,00 €
