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AAMI

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  • AAMI Standards online

    1/1/2017 - CD-Rom - English - USA - AAMI - - AAMI Standards online
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    €2,150.50

  • AAMI Standards - Dialysis (PDF Format)

    1/1/2015 - PDF sécurisé - English - USA - AAMI - - AAMI Standards - Dialysis
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    €486.90

  • AAMI TIR12:2010

    10/26/2010 - PDF sécurisé - English - USA - AAMI - - Designing, testing and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers
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    €204.24

  • AAMI TIR15:2009/(R) 2013

    9/3/2009 - PDF sécurisé - English - USA - AAMI - - Physical aspects of ethylene oxide sterilization
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    €121.50

  • AAMI TIR17:2008

    11/20/2008 - PDF sécurisé - English - USA - AAMI - - Compatibility of materials subject to sterilization
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    €223.56

  • AAMI TIR30:2011

    9/15/2011 - PDF sécurisé - English - USA - AAMI - - A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices
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    €191.36

  • AAMI TIR31:2008

    6/1/2008 - PDF sécurisé - English - USA - AAMI - - Process challenge devices/test packs for use in health care facilities
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    €168.36

  • AAMI TIR36:2007

    3/17/2007 - PDF sécurisé - English - USA - AAMI - - Validation of Software for Regulated Processes
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    €237.36

  • AAMI TIR39:2009

    11/23/2009 - PDF sécurisé - English - USA - AAMI - - Guidance on selecting a microbial challenge and inoculation sites for sterilization validation of medical devices
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    €90.16

  • AAMI TIR52:2014

    3/10/2014 - PDF sécurisé - English - USA - AAMI - - Environmental monitoring for terminally sterilized healthcare products
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    €95.68

  • Sterilization in Health Care Facilities, 2015 Edition

    5/1/2015 - CD-Rom et pdf - English - USA - AAMI - - Sterilization Part 1: Sterilization in Health Care Facilities, 2015 edition (PDF Format on CD)
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    €575.00

  • ANSI/AAMI BP 22:1994

    1/1/1994 - PDF sécurisé - English - USA - AAMI - - Blood pressure transducers
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    €101.20

  • ANSI/AAMI NS 28:1988

    1/1/1988 - PDF sécurisé - English - USA - AAMI - - Intracranial pressure monitoring devices
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    €109.48

  • ANSI/AAMI ST 24:1999

    1/1/1999 - PDF sécurisé - English - USA - AAMI - - Automatic, general-purpose ethylene oxide sterilizers and ethylene oxide sterilant sources intended for use in health care facilities
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    €124.20

  • ANSI/AAMI/ISO 10993-9:1999

    1/1/1999 - PDF sécurisé - English - USA - AAMI - - Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products
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    €101.20

  • ANSI/AAMI/ISO 10993-15:2000

    1/1/2000 - PDF sécurisé - English - USA - AAMI - - Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys
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    €109.48

  • ANSI/AAMI/ISO 10993-14:2001

    1/1/2001 - PDF sécurisé - English - USA - AAMI - - Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics
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    €95.68

  • ANSI/AAMI/ISO 10993-17:2002

    1/1/2002 - PDF sécurisé - English - USA - AAMI - - Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances
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    €136.16

  • ANSI/AAMI/ISO 10993-4:2002

    1/1/2002 - PDF sécurisé - English - USA - AAMI - - Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood
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    €124.20

  • ANSI/AAMI/ISO 25539-1:2003

    1/1/2003 - PDF sécurisé - English - USA - AAMI - - Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses
    Learn More
    €151.80

  • ANSI/AAMI ST 50:2004

    1/1/2004 - PDF sécurisé - English - USA - AAMI - - Dry heat (heated air) sterilizers
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    €136.16

  • ANSI/AAMI ST 40:2004

    1/1/2004 - PDF sécurisé - English - USA - AAMI - - Table-top dry heat (heated air) sterilization and sterility assurance in health care facilities
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    €170.20

  • ANSI/AAMI ST 81:2004

    1/1/2004 - PDF sécurisé - English - USA - AAMI - - Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices
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    €136.16

  • ANSI/AAMI/ISO 25539-1/A1:2005

    1/1/2005 - PDF sécurisé - English - USA - AAMI - - Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses, Amendment 1: Test methods
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    €151.80

  • ANSI/AAMI/ISO 17665-1:2005

    1/1/2005 - PDF sécurisé - English - USA - AAMI - - Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
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    €170.20

  • ANSI/AAMI/ISO 11137-1:2006

    1/1/2006 - PDF sécurisé - English - USA - AAMI - - Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
    Learn More
    €180.32

  • ANSI/AAMI/ISO 11137-3:2006

    1/1/2006 - PDF sécurisé - English - USA - AAMI - - Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects
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    €109.48

  • ANSI/AAMI/ISO 11737-1:2006

    1/1/2006 - PDF sécurisé - English - USA - AAMI - - Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products
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    €145.36

  • ANSI/AAMI/ISO 11138-1:2006

    1/1/2006 - PDF sécurisé - English - USA - AAMI - - Sterilization of health care products - Biological indicators - Part 1: General requirements
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    €170.20

  • ANSI/AAMI/ISO 11138-4:2006

    1/1/2006 - PDF sécurisé - English - USA - AAMI - - Sterilization Of Health Care Products - Biological Indicators - Part 4: Biological Indicators For Dry Heat Sterilization Processes
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    €87.40

  • ANSI/AAMI/ISO 11138-5:2006

    1/1/2006 - PDF sécurisé - English - USA - AAMI - - Sterilization Of Health Care Products - Biological Indicators - Part 5: Biological Indicators For Low-Temperature Steam And Formaldehyde Sterilization Processes
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    €87.40

  • ANSI/AAMI BE 83:2006

    1/1/2006 - PDF sécurisé - English - USA - AAMI - - Biological evaluation of medical devices - Part 18: Chemical characterization of materials
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    €109.48

  • ANSI/AAMI/ISO 10993-2:2006

    1/1/2006 - PDF sécurisé - English - USA - AAMI - - Biological evaluation of medical devices - Part 2: Animal welfare requirements
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    €101.20

  • ANSI/AAMI/ISO 10993-4 AMD 1:2006

    1/1/2006 - PDF sécurisé - English - USA - AAMI - - Biological evaluation of medical devices - Part 4: Selection of test for interactions with blood (Amendment 1)
    Learn More
    €124.20

  • ANSI/AAMI/ISO 14971:2007

    1/1/2007 - PDF sécurisé - English - USA - AAMI - - Medical devices - Risk management - Application of risk management to medical devices
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    €207.00

  • ANSI/AAMI/ISO 10993-11:2006

    1/1/2006 - PDF sécurisé - English - USA - AAMI - - Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
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    €124.20

  • ANSI/AAMI/ISO 22442-3:2007

    1/1/2007 - PDF sécurisé - English - USA - AAMI - - Medical devices utilizing animal tissues and their derivatives - Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents
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    €124.20

  • ANSI/AAMI RD 47:2008

    1/1/2008 - PDF sécurisé - English - USA - AAMI - - Reprocessing of hemodialyzers
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    €179.40

  • ANSI/AAMI ST 41:2008

    1/1/2008 - PDF sécurisé - English - USA - AAMI - - Ethylene oxide sterilization in health care facilities: Safety and effectiveness
    Learn More
    €222.64

  • ANSI/AAMI/ISO 13408-1:2008

    1/1/2008 - PDF sécurisé - English - USA - AAMI - - Aseptic processing of health care products - Part 1: General requirements
    Learn More
    €204.24

  • ANSI/AAMI/ISO 13408-6:2005

    1/1/2005 - PDF sécurisé - English - USA - AAMI - - Aseptic processing of health care products - Part 6: Isolator systems
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    €101.20

  • ANSI/AAMI/ISO 13408-2:2003

    1/1/2003 - PDF sécurisé - English - USA - AAMI - - Aseptic processing of health care products - Part 2: Filtration
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    €101.20

  • ANSI/AAMI/ISO 13408-4:2005

    1/1/2005 - PDF sécurisé - English - USA - AAMI - - Aseptic processing of health care products - Part 4: Clean-in-place technologies
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    €101.20

  • ANSI/AAMI/ISO 10993-7:2008

    1/1/2008 - PDF sécurisé - English - USA - AAMI - - Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
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    €179.40

  • ANSI/AAMI ST 65:2008

    1/1/2008 - PDF sécurisé - English - USA - AAMI - - Processing of reusable surgical textiles for use in health care facilities
    Learn More
    €179.40

  • ANSI/AAMI/ISO 15882:2008

    1/1/2008 - PDF sécurisé - English - USA - AAMI - - Sterilization of health care products - Chemical indicators - Guidance for selection, use and interpretation of results
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    €151.80

  • ANSI/AAMI/IEC 60601-2-19:2009

    1/1/2009 - PDF sécurisé - English - USA - AAMI - - Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators
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    €151.80

  • ANSI/AAMI/IEC 60601-2-20:2009

    1/1/2009 - PDF sécurisé - English - USA - AAMI - - Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators
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    €151.80

  • ANSI/AAMI/IEC 60601-2-2:2009

    1/1/2009 - PDF sécurisé - English - USA - AAMI - - 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
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    €179.40

  • ANSI/AAMI/IEC 60601-2-50:2009

    1/1/2009 - PDF sécurisé - English - USA - AAMI - - Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment
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    €119.60

  • ANSI/AAMI/ISO 14708-3:2008

    1/1/2008 - PDF sécurisé - English - USA - AAMI - - Implants for surgery - Active implantable medical devices - Part 3: Implantable neurostimulators
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    €170.20

  • ANSI/AAMI/ISO 14708-4:2008

    1/1/2008 - PDF sécurisé - English - USA - AAMI - - Implants for surgery - Active implantable medical devices - Part 4: Implantable infusion pumps
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    €191.36

  • ANSI/AAMI/ISO 10993-5:2009

    1/1/2009 - PDF sécurisé - English - USA - AAMI - - Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
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    €124.20

  • ANSI/AAMI/IEC 80601-2-30:2009

    1/1/2009 - PDF sécurisé - English - USA - AAMI - - Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
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    €204.24

  • ANSI/AAMI/ISO 10993-1:2009

    1/1/2009 - PDF sécurisé - English - USA - AAMI - - Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
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    €124.20

  • ANSI/AAMI/ISO 11737-2:2009

    1/1/2009 - PDF sécurisé - English - USA - AAMI - - Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
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    €101.20

  • ANSI/AAMI/IEC 80601-2-30/C1:2009

    1/1/2009 - PDF sécurisé - English - USA - AAMI - - Medical electrical equipment - Part 2-30: Particular requirements for basic safety and essential performance of automated type non-invasive sphygmomanometers
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    €179.40

  • ANSI/AAMI/ISO 14161:2009

    1/1/2009 - PDF sécurisé - English - USA - AAMI - - Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of results
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    €179.40

  • ANSI/AAMI/ISO 14708-5:2010

    1/1/2010 - PDF sécurisé - English - USA - AAMI - - Implants for surgery - Active implantable medical devices - Part 5: Circulatory support devices
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    €192.28

  • ANSI/AAMI/ISO 10993-10:2010

    1/1/2010 - PDF sécurisé - English - USA - AAMI - - Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
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    €179.40

  • ANSI/AAMI/ISO 8638:2010

    1/1/2010 - PDF sécurisé - English - USA - AAMI - - Cardiovascular implants and extracorporeal systems - Extracorporeal blood circuit for hemodialyzers, hemodiafilters and hemofilters
    Learn More
    €101.20

  • ANSI/AAMI ST 79:2010

    1/1/2010 - PDF sécurisé - English - USA - AAMI - - Comprehensive guide to steam sterilization and sterility assurance in health care facilities
    Learn More
    €285.20

  • ANSI/AAMI/IEC 80001-1:2010

    1/1/2010 - PDF sécurisé - English - USA - AAMI - - Application of risk management for IT Networks incorporating medical devices - Part 1: Roles, responsibilities and activities
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    €168.36

  • ANSI/AAMI/IEC 60601-2-4:2010

    1/1/2010 - PDF sécurisé - English - USA - AAMI - - Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators
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    €204.24

  • ANSI/AAMI/ISO 10993-13:2010

    1/1/2010 - PDF sécurisé - English - USA - AAMI - - Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices
    Learn More
    €87.40

  • ANSI/AAMI/ISO 14155:2010

    1/1/2010 - PDF sécurisé - English - USA - AAMI - - Clinical investigation of medical devices for human subjects - Good clinical practice
    Learn More
    €204.24

  • ANSI/AAMI/ISO 20857:2010

    1/1/2010 - PDF sécurisé - English - USA - AAMI - - Sterilization of health care products - Dry heat: Requirements for the development, validation and routine control of a sterilization process for medical devices
    Learn More
    €204.24

  • ANSI/AAMI ST 67:2011

    1/1/2011 - PDF sécurisé - English - USA - AAMI - - Sterilization of health care products - Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled sterile
    Learn More
    €109.48

  • ANSI/AAMI/IEC 60601-2-27:2011

    1/1/2011 - PDF sécurisé - English - USA - AAMI - - Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment
    Learn More
    €179.40

  • ANSI/AAMI ST 79/A 2.1:2011

    1/1/2011 - PDF sécurisé - English - USA - AAMI - - Comprehensive guide to steam sterilization and sterility assurance in health care facilities
    Learn More
    €87.40

  • ANSI/AAMI/ISO 27186:2010

    1/1/2010 - PDF sécurisé - English - USA - AAMI - - Active implantable medical devices - Four-pole connector system for implantable cardiac rhythm management devices - Dimensional and test requirements
    Learn More
    €237.36

  • ANSI/AAMI/ISO 14160:2011

    1/1/2011 - PDF sécurisé - English - USA - AAMI - - 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 process for medical devices
    Learn More
    €179.40

  • ANSI/AAMI/ISO 27185:2012

    1/1/2012 - PDF sécurisé - English - USA - AAMI - - Cardiac rhythm management devices - Symbols to be used with cardiac rhythm management device labels, and information to be supplied - General requirements
    Learn More
    €199.80

  • ANSI/AAMI/ISO 7199/A1:2011

    1/1/2011 - PDF sécurisé - English - USA - AAMI - - Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) Amendment 1
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    €101.20

  • ANSI/AAMI ES 60601-1 C 1 and A2:2009

    1/1/2009 - PDF sécurisé - English - USA - AAMI - - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    Learn More
    €844.56

  • ANSI/AAMI/IEC 60601-2-25:2011

    1/1/2011 - PDF sécurisé - English - USA - AAMI - - Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs
    Learn More
    €207.00

  • ANSI/AAMI ST 15883-1:2009

    1/1/2009 - PDF sécurisé - English - USA - AAMI - - Washer-disinfectors, Part 1: General requirements, terms and definitions and tests
    Learn More
    €204.24

  • ANSI/AAMI/ISO 25539-3:2012

    1/1/2012 - PDF sécurisé - English - USA - AAMI - - Cardiovascular Implants - Endovascular Devices - Part 3: Vena Cava Filters
    Learn More
    €237.36

  • ANSI/AAMI SW 87:2012

    1/1/2012 - PDF sécurisé - English - USA - AAMI - - Application of Quality Management System concepts to Medical Device Data Systems (MDDS)
    Learn More
    €124.20

  • ANSI/AAMI PB 70:2012

    1/1/2012 - PDF sécurisé - English - USA - AAMI - - Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities
    Learn More
    €136.16

  • ANSI/AAMI/ISO 11658:2012

    1/1/2012 - PDF sécurisé - English - USA - AAMI - - Cardiovascular implants and extracorporeal systems - Blood/tissue contact surface modifications for extracorporeal perfusion systems
    Learn More
    €95.68

  • ANSI/AAMI/IEC 60601-2-47:2012

    1/1/2012 - PDF sécurisé - English - USA - AAMI - - Medical electrical equipment - Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems.
    Learn More
    €179.40

  • ANSI/AAMI/ISO 10993-12:2012

    1/1/2012 - PDF sécurisé - English - USA - AAMI - - Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
    Learn More
    €124.20

  • ANSI/AAMI ES 60601-1/Amendment 1:2012

    1/1/2012 - PDF sécurisé - English - USA - AAMI - - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance Amendment 1
    Learn More
    €224.00

  • ANSI/AAMI ST 79/A 3.1:2012

    1/1/2012 - PDF sécurisé - English - USA - AAMI - - Comprehensive guide to steam sterilization and sterility assurance in health care facilities
    Learn More
    €285.20

  • ANSI/AAMI ST 79/A 3.2:2012

    1/1/2012 - PDF sécurisé - English - USA - AAMI - - Comprehensive guide to steam sterilization and sterility assurance in health care facilities
    Learn More
    €220.80

  • ANSI/AAMI/ISO 13408-7:2012

    1/1/2012 - PDF sécurisé - English - USA - AAMI - - Aseptic processing of health care products - Part 7: Alternative processes for atypical medical devices and combination products
    Learn More
    €124.20

  • ANSI/AAMI ST 15883-1/A2:2012

    1/1/2012 - PDF sécurisé - English - USA - AAMI - - Washer-disinfectors - Part 1: General requirements, terms and definitions and tests, Amendment 2
    Learn More
    €32.20

  • ANSI/AAMI/IEC 60601-2-16:2012

    1/1/2012 - PDF sécurisé - English - USA - AAMI - - Medical electrical equipment - Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
    Learn More
    €204.24

  • ANSI/AAMI ST 15883-3:2012

    1/1/2012 - PDF sécurisé - English - USA - AAMI - - Washer-disinfectors, Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers
    Learn More
    €109.48

  • ANSI/AAMI/ISO 5840-3:2012

    1/1/2012 - PDF sécurisé - English - USA - AAMI - - Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by minimally invasive techniques
    Learn More
    €235.52

  • ANSI/AAMI/ISO 8637 AMD 1:2013

    1/1/2013 - PDF sécurisé - English - USA - AAMI - - Cardiovascular Implants and Extracorporeal Systems - Hemodialyzers, Hemodiafilters, Hemofilters and Hemoconcentrators
    Learn More
    €32.20

  • ANSI/AAMI EC 57:2012

    1/1/2012 - PDF sécurisé - English - USA - AAMI - - Testing and reporting performance results of cardiac rhythm and ST segment measurement algorithms
    Learn More
    €168.36

  • ANSI/AAMI BF 7:2012

    1/1/2012 - PDF sécurisé - English - USA - AAMI - - Blood transfusion microfilters
    Learn More
    €101.20

  • ANSI/AAMI/ISO 14117:2012

    1/1/2012 - PDF sécurisé - English - USA - AAMI - - Active implantable medical devices - Electromagnetic compatibility - EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices
    Learn More
    €207.00

  • ANSI/AAMI BF 64:2012

    1/1/2012 - PDF sécurisé - English - USA - AAMI - - Leukocyte reduction filters
    Learn More
    €101.20

  • ANSI/AAMI/ISO 25539-2:2012

    1/1/2012 - PDF sécurisé - English - USA - AAMI - - Cardiovascular implants - Endovascular devices - Part 2: Vascular stents
    Learn More
    €237.36

  • ANSI/AAMI ST 15883-2:2013

    1/1/2013 - PDF sécurisé - English - USA - AAMI - - Washer-disinfectors, Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc
    Learn More
    €109.48

  • ANSI/AAMI EQ 56:2013

    1/1/2013 - PDF sécurisé - English - USA - AAMI - - Recommended practice for a medical equipment management program
    Learn More
    €168.36

  • ANSI/AAMI ST 77:2013

    1/1/2013 - PDF sécurisé - English - USA - AAMI - - Containment devices for reusable medical device sterilization
    Learn More
    €136.16

  • ANSI/AAMI NS 4:2013

    1/1/2013 - PDF sécurisé - English - USA - AAMI - - Transcutaneous electrical stimulators
    Learn More
    €101.20

  • ANSI/AAMI/ISO 13408-1/A1:2013

    1/1/2013 - PDF sécurisé - English - USA - AAMI - - Aseptic processing of health care products - Part 1: General requirements
    Learn More
    €175.50

  • ANSI/AAMI/IEC 60601-1-8:2013

    1/1/2013 - PDF sécurisé - English - USA - AAMI - - 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
    Learn More
    €634.80

  • ANSI/AAMI/IEC 80601-2-30/A1:2013

    1/1/2013 - PDF sécurisé - English - USA - AAMI - - Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated type non-invasive sphygmomanometers and Amendment 1
    Learn More
    €32.20

  • ANSI/AAMI EC 53:2013

    1/1/2013 - PDF sécurisé - English - USA - AAMI - - ECG trunk cables and patient leadwires
    Learn More
    €101.20

  • ANSI/AAMI/ISO 11137-1 AMD 1:2013

    1/1/2013 - PDF sécurisé - English - USA - AAMI - - Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices - Amendment 1
    Learn More
    €32.20

  • ANSI/AAMI/ISO 14937:2009

    1/1/2009 - PDF sécurisé - English - USA - AAMI - - 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
    Learn More
    €151.80

  • ANSI/AAMI ST 15883-1/A1:2014

    1/1/2014 - PDF sécurisé - English - USA - AAMI - - Washer-disinfectors - Part 1: General requirements, terms and definitions and tests - Amendment 1
    Learn More
    €179.40

  • ANSI/AAMI/ISO 5841-2:2014

    1/1/2014 - PDF sécurisé - English - USA - AAMI - - Implants for surgery - Cardiac pacemakers - Part 2: Reporting of clinical performance of populations of pulse generators or leads
    Learn More
    €136.16

  • ANSI/AAMI 13958:2014

    1/1/2014 - PDF sécurisé - English - USA - AAMI - - Concentrates for haemodialysis and related therapies
    Learn More
    €124.20

  • ANSI/AAMI 11663:2014

    1/1/2014 - PDF sécurisé - English - USA - AAMI - - Quality of dialysis fluid for haemodialysis and related therapies
    Learn More
    €101.20

  • ANSI/AAMI 13959:2014

    1/1/2014 - PDF sécurisé - English - USA - AAMI - - Water for haemodialysis and related therapies
    Learn More
    €124.20

  • ANSI/AAMI 26722:2014

    1/1/2014 - PDF sécurisé - English - USA - AAMI - - Water treatment equipment for haemodialysis applications and related therapies
    Learn More
    €151.80

  • ANSI/AAMI 23500:2014

    1/1/2014 - PDF sécurisé - English - USA - AAMI - - Guidance for the preparation and quality management of fluids for haemodialysis and related therapies
    Learn More
    €207.00

  • ANSI/AAMI/ISO 11607-1 AMD 1:2014

    1/1/2014 - PDF sécurisé - English - USA - AAMI - - Amendment 1 to ANSI/AAMI/ISO 11607-1:2006, Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems, and packaging
    Learn More
    €32.20

  • ANSI/AAMI/ISO 11607-2 AMD 1:2014

    1/1/2014 - PDF sécurisé - English - USA - AAMI - - Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
    Learn More
    €32.20

  • ANSI/AAMI/ISO 10993-3:2014

    1/1/2014 - PDF sécurisé - English - USA - AAMI - - Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
    Learn More
    €109.48

  • ANSI/AAMI/ISO 11140-1:2014

    1/1/2014 - PDF sécurisé - English - USA - AAMI - - Sterilization of health care products - Chemical indicators - Part 1: General requirements
    Learn More
    €136.16

  • ANSI/AAMI ST 72:2011 (R2016)

    1/1/2011 - PDF sécurisé - English - USA - AAMI - - Bacterial endotoxin - Test methods, routine monitoring and alternatives to batch testing
    Learn More
    €199.00

  • ANSI/AAMI/IEC 80601-2-58:2014

    1/1/2014 - PDF sécurisé - English - USA - AAMI - - Medical electrical equipment - Part 2-58: Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery
    Learn More
    €136.16

  • ANSI/AAMI/ISO 14708-1:2014

    1/1/2014 - PDF sécurisé - English - USA - AAMI - - Implants for surgery - Active implantable medical devices - Part 1: General requirements for safety, marking and for information to be provided by the manufacturer
    Learn More
    €204.24

  • ANSI/AAMI EQ 89:2015

    1/1/2015 - PDF sécurisé - English - USA - AAMI - - Guidance for the use of medical equipment maintenance strategies and procedures
    Learn More
    €168.36

  • ANSI/AAMI/IEC 62366-1:2015

    1/1/2015 - PDF sécurisé - English - USA - AAMI - - Medical devices - Application of usability Engineering to medical devices
    Learn More
    €191.36

  • ANSI/AAMI/ISO 80369-20:2015

    1/1/2015 - PDF sécurisé - English - USA - AAMI - - Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods
    Learn More
    €191.36

  • ANSI/AAMI ST 91:2015

    1/1/2015 - PDF sécurisé - English - USA - AAMI - - Flexible and semi-rigid endoscope reprocessing in health care facilities
    Learn More
    €204.24

  • ANSI/AAMI/ISO 10993-16:2010

    1/1/2010 - PDF sécurisé - English - USA - AAMI - - Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables
    Learn More
    €95.68

  • ANSI/AAMI/ISO 13408-3:2012

    1/1/2012 - PDF sécurisé - English - USA - AAMI - - Aseptic processing of health care products - Part 3: Lyophilization
    Learn More
    €109.48

  • ANSI/AAMI/ISO 11135:2015

    1/1/2015 - PDF sécurisé - English - USA - AAMI - - Sterilization of health care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
    Learn More
    €237.36

  • ANSI/AAMI HA 60601-1-11:2015

    1/1/2015 - PDF sécurisé - English - USA - AAMI - - 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
    Learn More
    €285.20

  • ANSI/AAMI/ISO 13408-5:2012

    1/1/2012 - PDF sécurisé - English - USA - AAMI - - Aseptic processing of health care products - Part 5: Sterilization in place
    Learn More
    €109.48

  • AAMI TIR29:2012

    1/1/2012 - PDF sécurisé - English - USA - AAMI - - Guide for process characterization and control in radiation sterilization of medical devices
    Learn More
    €191.36

  • ANSI/AAMI/ISO 5840-2:2015

    1/1/2015 - PDF sécurisé - English - USA - AAMI - - Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes
    Learn More
    €204.24

  • ANSI/AAMI/ISO 12417-1:2015

    1/1/2015 - PDF sécurisé - English - USA - AAMI - - Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 1: General requirements
    Learn More
    €179.40

  • ANSI/AAMI/ISO 5840-1:2015

    1/1/2015 - PDF sécurisé - English - USA - AAMI - - Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements
    Learn More
    €204.24

  • ANSI/AAMI/ISO 80369-6:2016

    1/1/2016 - PDF sécurisé - English - USA - AAMI - - Small-bore connectors for liquids and gases in healthcare applications -- Part 6: Connectors for neuraxial applications
    Learn More
    €204.24

  • ANSI/AAMI/IEC 62304 AMD 1:2016

    1/1/2016 - PDF sécurisé - English - USA - AAMI - - Medical device software - Software life cycle processes, Amendment 1
    Learn More
    €180.32

  • ANSI/AAMI/ISO 15223-2:2016

    1/1/2016 - PDF sécurisé - English - USA - AAMI - - Medical devices - Symbols to be used with medical device labels, labeling and information to be supplied - Part 2: Symbol development, selection and validation
    Learn More
    €109.48

  • ANSI/AAMI/ISO 13485:2016

    1/1/2016 - PDF sécurisé - English - USA - AAMI - - Medical devices - Quality management systems - Requirements for regulatory purposes
    Learn More
    €199.80

  • ANSI/AAMI/ISO 80369-5:2016

    1/1/2016 - PDF sécurisé - English - USA - AAMI - - Small-bore connectors for liquids and gases in healthcare application - Part 5: Connectors for limb cuff inflation applications
    Learn More
    €168.36

  • ANSI/AAMI/ISO 16142-1:2016

    1/1/2016 - PDF sécurisé - English - USA - AAMI - - 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
    Learn More
    €204.24

  • ANSI/AAMI/ISO 15225:2016

    1/1/2016 - PDF sécurisé - English - USA - AAMI - - Medical devices - Quality management - Medical device nomenclature data structure
    Learn More
    €136.16

  • ANSI/AAMI/IEC 60601-1-12:2016

    1/1/2016 - PDF sécurisé - English - USA - AAMI - - 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 the emergency medical services environment
    Learn More
    €204.24

  • ANSI/AAMI/ISO 13408-6/A1:2013

    1/1/2013 - PDF sécurisé - English - USA - AAMI - - Aseptic processing of health care products - Part 6: Isolator systems - Amendment 1
    Learn More
    €55.20

  • ANSI/AAMI ST 8:2013

    1/1/2013 - PDF sécurisé - English - USA - AAMI - - Hospital steam sterilizers
    Learn More
    €159.16

  • ANSI/AAMI/ISO 5841-3:2013

    1/1/2013 - PDF sécurisé - English - USA - AAMI - - Implants for surgery - Cardiac pacemakers - Part 3: Low-profile connectors (IS-1) for implantable pacemakers
    Learn More
    €109.48

  • ANSI/AAMI ST 58:2013

    1/1/2013 - PDF sécurisé - English - USA - AAMI - - Chemical sterilization and high-level disinfection in health care facilities
    Learn More
    €223.56

  • ANSI/AAMI/ISO 11137-2:2013

    1/1/2013 - PDF sécurisé - English - USA - AAMI - - Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
    Learn More
    €192.28

  • ANSI/AAMI/ISO 11140-4:2012

    1/1/2012 - PDF sécurisé - English - USA - AAMI - - 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
    Learn More
    €168.36

  • ANSI/AAMI/ISO 11140-3:2012

    1/1/2012 - PDF sécurisé - English - USA - AAMI - - Sterilization Of Health Care Products - Chemical Indicators - Part 3: Class 2 Indicator Systems For Use In The Bowie And Dick-Type Steam Penetration Test
    Learn More
    €168.36

  • ANSI/AAMI/ISO 11140-5:2012

    1/1/2012 - PDF sécurisé - English - USA - AAMI - - Sterilization of Health Care Products - Chemical Indicators - Part 5: Class 2 Indicators for Bowie and Dick Air Removal Test Sheets and Packs
    Learn More
    €136.16

  • ANSI/AAMI ST 79/A 2.2:2011

    1/1/2011 - PDF sécurisé - English - USA - AAMI - - Comprehensive guide to steam sterilization and sterility assurance in health care facilities
    Learn More
    €0.00
  • ANSI/AAMI ST 79/A 2.3:2011

    1/1/2011 - PDF sécurisé - English - USA - AAMI - - Comprehensive guide to steam sterilization and sterility assurance in health care facilities
    Learn More
    €0.00
  • ANSI/AAMI ST 79/A 2.5:2011

    1/1/2011 - PDF sécurisé - English - USA - AAMI - - Comprehensive guide to steam sterilization and sterility assurance in health care facilities
    Learn More
    €0.00
  • ANSI/AAMI/ISO 13022:2012

    1/1/2012 - PDF sécurisé - English - USA - AAMI - - Medical products containing viable human cells -- Application of risk management and requirements for processing practices
    Learn More
    €192.28

  • ANSI/AAMI ST 79/A 3.3:2012

    1/1/2012 - PDF sécurisé - English - USA - AAMI - - Comprehensive guide to steam sterilization and sterility assurance in health care facilities
    Learn More
    €0.00
  • ANSI/AAMI ST 79/A 3.4:2012

    1/1/2012 - PDF sécurisé - English - USA - AAMI - - Comprehensive guide to steam sterilization and sterility assurance in health care facilities
    Learn More
    €0.00
  • ANSI/AAMI ST 79/A 3.5:2012

    1/1/2012 - PDF sécurisé - English - USA - AAMI - - Comprehensive guide to steam sterilization and sterility assurance in health care facilities
    Learn More
    €0.00
  • ANSI/AAMI ST 79/A 3.6:2012

    1/1/2012 - PDF sécurisé - English - USA - AAMI - - Comprehensive guide to steam sterilization and sterility assurance in health care facilities
    Learn More
    €0.00
  • ANSI/AAMI ST 79/A 3.7:2012

    1/1/2012 - PDF sécurisé - English - USA - AAMI - - Comprehensive guide to steam sterilization and sterility assurance in health care facilities
    Learn More
    €0.00
  • ANSI/AAMI ST 79/A 4.1:2013

    1/1/2013 - PDF sécurisé - English - USA - AAMI - - Comprehensive guide to steam sterilization and sterility assurance in health care facilities
    Learn More
    €0.00
  • ANSI/AAMI ST 79/A 4.2:2013

    1/1/2013 - PDF sécurisé - English - USA - AAMI - - Comprehensive guide to steam sterilization and sterility assurance in health care facilities
    Learn More
    €0.00
  • ANSI/AAMI/ISO 18472:2010

    1/1/2010 - PDF sécurisé - English - USA - AAMI - - Sterilization of Health Care Products - Biological and Chemical Indicators - Test Equipment
    Learn More
    €191.36

  • ANSI/AAMI/ISO 81060-1:2007

    1/1/2007 - PDF sécurisé - English - USA - AAMI - - Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated meaasurement type
    Learn More
    €180.32

  • ANSI/AAMI/ISO 80369-1:2010

    1/1/2010 - PDF sécurisé - English - USA - AAMI - - Small bore connectors for liquids and gases in healthcare applications - Part 1: General requirements
    Learn More
    €168.36

  • AAMI TIR33:2005

    10/25/2006 - PDF sécurisé - English - USA - AAMI - - Sterilization of health care products - Radiation - Substantiation of a selected sterilization dose - Method VDmax
    Learn More
    €204.24

  • ANSI/AAMI/ISO 23747:2015

    1/1/2015 - PDF sécurisé - English - USA - AAMI - - Anaesthetic and respiratory equipment - Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans
    Learn More
    €124.20

  • ANSI/AAMI/ISO 5359:2015

    1/1/2015 - PDF sécurisé - English - USA - AAMI - - Anaesthetic and respiratory equipment - Low-pressure hose assemblies for use with medical gases
    Learn More
    €130.64

  • AAMI TIR42:2010

    12/13/2010 - PDF sécurisé - English - USA - AAMI - - Evaluation of particulates associated with vascular medical devices
    Learn More
    €191.36

  • AAMI TIR34:2014

    4/8/2014 - PDF sécurisé - English - USA - AAMI - - Water for the reprocessing of medical devices
    Learn More
    €201.00

  • AAMI TIR57:2016

    8/3/2016 - PDF sécurisé - English - USA - AAMI - - Principles for Medical Device Security - Risk Management
    Learn More
    €231.00

  • ANSI/AAMI/ISO 11138-3:2006

    1/1/2006 - PDF sécurisé - English - USA - AAMI - - Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes
    Learn More
    €87.40

  • ANSI/AAMI/ISO 11138-2:2006

    1/1/2006 - PDF sécurisé - English - USA - AAMI - - Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes
    Learn More
    €87.40

  • ANSI/AAMI/ISO 14708-3:2017

    1/1/2017 - PDF sécurisé - English - USA - AAMI - - Implants for surgery - Active implantable medical devices - Part 3: Implantable neurostimulators
    Learn More
    €192.28

  • ANSI/AAMI/ISO 5367:2015

    1/1/2015 - PDF sécurisé - English - USA - AAMI - - Anaesthetic and respiratory equipment - Breathing sets and connectors
    Learn More
    €191.36

  • ANSI/AAMI/ISO 26782:2015

    1/1/2015 - PDF sécurisé - English - USA - AAMI - - Anaesthetic and respiratory equipment - Spirometers intended for the measurement of time forced expired volumes in humans
    Learn More
    €168.36

  • ANSI/AAMI EC 12:2010

    1/1/2010 - PDF sécurisé - English - USA - AAMI - - Disposable ECG electrodes
    Learn More
    €109.48

  • ANSI/AAMI/ISO 8836:2015

    1/1/2015 - PDF sécurisé - English - USA - AAMI - - Suction catheters for use in the respiratory tract
    Learn More
    €168.36

  • ANSI/AAMI/ISO 80369-7:2016

    1/1/2016 - PDF sécurisé - English - USA - AAMI - - Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors with 6% (Luer) taper for intravascular or hypodermic applications
    Learn More
    €170.20

  • ANSI/AAMI/ISO 80369-3:2016

    1/1/2016 - PDF sécurisé - English - USA - AAMI - - Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications
    Learn More
    €204.24

  • ANSI/AAMI ID 54:1996

    1/1/1996 - PDF sécurisé - English - USA - AAMI - - Enteral feeding set adapters and connectors
    Learn More
    €58.88

  • ANSI/AAMI CI 86:2017

    1/1/2017 - PDF sécurisé - English - USA - AAMI - - Cochlear implant systems - Safety, performance and reliability
    Learn More
    €232.20

  • AAMI TIR28:2016

    1/1/2012 - PDF sécurisé - English - USA - AAMI - - Product adoption and process equivalence for ethylene oxide sterilization
    Learn More
    €107.00

  • ANSI/AAMI/ISO 15223-1:2016

    1/1/2016 - PDF sécurisé - English - USA - AAMI - - Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
    Learn More
    €223.20

  • ANSI/AAMI/ISO 18242:2016

    1/1/2016 - PDF sécurisé - English - USA - AAMI - - Cardiovascular implants and extracorporeal systems - Centrifugal blood pumps
    Learn More
    €144.90

  • ANSI/AAMI/ISO 18241:2016

    1/1/2016 - PDF sécurisé - English - USA - AAMI - - Cardiovascular implants and extracorporeal systems - Cardiopulmonary bypass systems - Venous bubble traps
    Learn More
    €180.00

  • ANSI/AAMI/ISO 15674:2016

    1/1/2016 - PDF sécurisé - English - USA - AAMI - - Cardiovascular implants and artificial organs - Hardshell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags
    Learn More
    €126.90

  • ANSI/AAMI/ISO 15675:2016

    1/1/2016 - PDF sécurisé - English - USA - AAMI - - Cardiovascular implants and artificial organs - Cardiopulmonary bypass systems - Arterial blood line filters
    Learn More
    €126.90

  • ANSI/AAMI/ISO 15676:2016

    1/1/2016 - PDF sécurisé - English - USA - AAMI - - Cardiovascular implants and artificial organs - Requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO)
    Learn More
    €144.90

  • ANSI/AAMI/ISO 25539-1:2017

    1/1/2017 - PDF sécurisé - English - USA - AAMI - - Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses
    Learn More
    €314.10

  • ANSI/AAMI/ISO 22442-2:2016

    1/1/2016 - PDF sécurisé - English - USA - AAMI - - Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling
    Learn More
    €144.90

  • ANSI/AAMI/ISO 22442-1:2016

    1/1/2016 - PDF sécurisé - English - USA - AAMI - - Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management
    Learn More
    €192.60

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