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  • AAMI HIT1000-4 (PS):2020

    Safety and effectiveness of health IT software and systems - Part 4: Application of human factors engineering
    7/7/2020 - PDF - English - AAMI
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    €21.53

  • AAMI/ISO 10993-4:2017

    Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood
    4/27/2020 - PDF - English - AAMI
    Learn More
    €249.08

  • AAMI/ISO 10993-1:2018

    Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
    4/27/2020 - PDF - English - AAMI
    Learn More
    €249.08

  • AAMI/ISO 10993-11:2017

    Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
    4/27/2020 - PDF - English - AAMI
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    €205.00

  • AAMI MP80601-2-49:2020

    Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitors
    3/24/2020 - PDF - English - AAMI
    Learn More
    €233.70

  • AAMI RT3: 2020

    Radiation therapy machine characterization
    2/21/2020 - Paper - English - AAMI
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    €39.52

  • AAMI RD47:2020

    Reprocessing of hemodialyzers
    1/23/2020 - Paper - English - AAMI
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    €294.32

  • AAMI RD47:2020

    Reprocessing of hemodialyzers
    1/23/2020 - PDF - English - AAMI
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    €249.08

  • Medical Devices - A Practical Guide, Advice from ISO/TC 210 (13485:2016)

    Test methods for electrical steel strip and sheet -- Part 3: Methods of measurement of the magnetic properties of electrical steel strip and sheet at medium frequencies
    1/22/2020 - Paper - English - AAMI
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    €197.60

  • Medical Devices - A Practical Guide, Advice from ISO/TC 210 (13485:2016)

    Test methods for electrical steel strip and sheet -- Part 3: Methods of measurement of the magnetic properties of electrical steel strip and sheet at medium frequencies
    1/22/2020 - PDF - English - AAMI
    Learn More
    €137.35

  • AAMI/ISO 80369-1:2018

    Small-bore connectors for liquids and gases in healthcare applications - Part 1: General requirements
    12/30/2019 - Paper - English - AAMI
    Learn More
    €163.28

  • AAMI/ISO 80369-1:2018

    Small-bore connectors for liquids and gases in healthcare applications - Part 1: General requirements
    12/30/2019 - PDF - English - AAMI
    Learn More
    €134.28

  • AAMI/ISO 80369-3:2016/A1:2019

    Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications - Amendment
    12/30/2019 - PDF - English - AAMI
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    €134.28

  • AAMI/ISO 23500-1:2019

    Preparation and quality management of fluids for haemodialysis and related therapies - Part 1: General requirements
    12/23/2019 - Paper - English - AAMI
    Learn More
    €334.88

  • AAMI/ISO 23500-1:2019

    Preparation and quality management of fluids for haemodialysis and related therapies - Part 1: General requirements
    12/23/2019 - PDF - English - AAMI
    Learn More
    €289.05

  • AAMI/ISO 23500-3:2019

    Preparation and quality management of fluids for haemodialysis and related therapies - Part 3: Water for haemodialysis and related therapies
    12/23/2019 - Paper - English - AAMI
    Learn More
    €195.52

  • AAMI/ISO 23500-3:2019

    Preparation and quality management of fluids for haemodialysis and related therapies - Part 3: Water for haemodialysis and related therapies
    12/23/2019 - PDF - English - AAMI
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    €166.05

  • AAMI/ISO 23500-5:2019

    Preparation and quality management of fluids for haemodialysis and related therapies - Part 5: Quality of dialysis fluid for haemodialysis and related therapies
    12/23/2019 - Paper - English - AAMI
    Learn More
    €195.52

  • AAMI/ISO 23500-5:2019

    Preparation and quality management of fluids for haemodialysis and related therapies - Part 5: Quality of dialysis fluid for haemodialysis and related therapies
    12/23/2019 - PDF - English - AAMI
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    €166.05

  • AAMI/ISO 23500-4:2019

    Preparation and quality management of fluids for haemodialysis and related therapies - Part 4: Concentrates for haemodialysis and related therapies
    12/23/2019 - Paper - English - AAMI
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    €235.04

  • AAMI/ISO 23500-4:2019

    Preparation and quality management of fluids for haemodialysis and related therapies - Part 4: Concentrates for haemodialysis and related therapies
    12/23/2019 - PDF - English - AAMI
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    €205.00

  • AAMI/ISO 23500-2:2019

    Preparation and quality management of fluids for haemodialysis and related therapies - Part 2: Water treatment equipment for haemodialysis applications and related therapies
    12/23/2019 - Paper - English - AAMI
    Learn More
    €264.16

  • AAMI/ISO 23500-2:2019

    Preparation and quality management of fluids for haemodialysis and related therapies - Part 2: Water treatment equipment for haemodialysis applications and related therapies
    12/23/2019 - PDF - English - AAMI
    Learn More
    €233.70

  • AAMI CR500:2019

    Basic Introduction to the IEC 60601 Series
    12/18/2019 - Paper - English - AAMI
    Learn More
    €195.52

  • AAMI CR500:2019

    Basic Introduction to the IEC 60601 Series
    12/18/2019 - PDF - English - AAMI
    Learn More
    €166.05

  • AAMI ST72:2019

    Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testing
    11/1/2019 - Paper - English - AAMI
    Learn More
    €294.32

  • AAMI ST72:2019

    Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testing
    11/1/2019 - PDF - English - AAMI
    Learn More
    €249.08

  • AAMI/ISO 11138-7:2019

    Sterilization of health care products - Biological indicators - Guidance for the selection, use, and interpretation of results
    11/1/2019 - Paper - English - AAMI
    Learn More
    €294.32

  • AAMI/ISO 11138-7:2019

    Sterilization of health care products - Biological indicators - Guidance for the selection, use, and interpretation of results
    11/1/2019 - PDF - English - AAMI
    Learn More
    €249.08

  • AAMI TIR97:2019

    Principles for medical device security - Postmarket risk management for device manufacturers
    9/27/2019 - Paper - English - AAMI
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    €294.32

  • AAMI TIR97:2019

    Principles for medical device security - Postmarket risk management for device manufacturers
    9/27/2019 - PDF - English - AAMI
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    €249.08

  • AAMI/ISO 14117:2019

    Active implantable medical devices - Electromagnetic compatibility - EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices
    9/27/2019 - Paper - English - AAMI
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    €351.52

  • AAMI/ISO 14117:2019

    Active implantable medical devices - Electromagnetic compatibility - EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices
    9/27/2019 - PDF - English - AAMI
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    €289.05

  • AAMI TIR102:2019

    U.S. FDA 21 CFR mapping to the applicable regulatory requirement references in ISO 13485:2016 Quality Management Systems
    8/30/2019 - Paper - English - AAMI
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    €351.52

  • AAMI TIR102:2019

    U.S. FDA 21 CFR mapping to the applicable regulatory requirement references in ISO 13485:2016 Quality Management Systems
    8/30/2019 - PDF - English - AAMI
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    €289.05

  • AAMI ST67:2019

    Sterilization of health care products - Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled "sterile"
    7/29/2019 - Paper - English - AAMI
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    €163.28

  • AAMI ST67:2019

    Sterilization of health care products - Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled "sterile"
    7/29/2019 - PDF - English - AAMI
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    €134.28

  • AAMI/ISO 11737-2: 2019

    Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
    7/11/2019 - Paper - English - AAMI
    Learn More
    €195.52

  • AAMI/ISO 11737-2: 2019

    Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
    7/11/2019 - PDF - English - AAMI
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    €166.05

  • 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
    7/1/2019 - Paper - English - AAMI
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    €235.04

  • 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
    7/1/2019 - PDF - English - AAMI
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    €205.00

  • AAMI TIR75:2019

    Factors to consider when multi-vendor devices interact via an electronic interface: Practical applications and examples
    6/1/2019 - Paper - English - AAMI
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    €235.04

  • AAMI TIR75:2019

    Factors to consider when multi-vendor devices interact via an electronic interface: Practical applications and examples
    6/1/2019 - PDF - English - AAMI
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    €205.00

  • AAMI/ISO 14971:2019

    Medical devices - Application of risk management to medical devices
    5/1/2019 - Paper - English - AAMI
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    €279.76

  • AAMI/ISO 14971:2019

    Medical devices - Application of risk management to medical devices
    5/1/2019 - PDF - English - AAMI
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    €249.08

  • AAMI/ISO 11137-1:2006 (R2015) A2:2019

    A2:2019 to Sterilization of health care products - Radiation - Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices
    5/1/2019 - PDF - English - AAMI
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    €113.78

  • AAMI EQ93:2019

    Medical equipment management - Vocabulary used in medical equipment programs
    4/18/2019 - Paper - English - AAMI
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    €145.60

  • AAMI EQ93:2019

    Medical equipment management - Vocabulary used in medical equipment programs
    4/18/2019 - PDF - English - AAMI
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    €116.85

  • AAMI/ISO 81060-2:2019

    Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type
    3/22/2019 - Paper - English - AAMI
    Learn More
    €264.16

  • AAMI/ISO 81060-2:2019

    Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type
    3/22/2019 - PDF - English - AAMI
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    €233.70

  • AAMI 2800-1:2019

    Standard for Safety for Medical Device Interoperability (ANSI/AAMI/UL 2800-1:2019)
    2/25/2019 - Paper - English - AAMI
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    €488.80

  • AAMI 2800-1:2019

    Standard for Safety for Medical Device Interoperability (ANSI/AAMI/UL 2800-1:2019)
    2/25/2019 - PDF - English - AAMI
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    €424.35

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

    Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators, including Amendment 1
    1/30/2019 - PDF - English - AAMI
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    €289.05

  • AAMI TIR38:2019

    Medical device safety assurance case report guidance
    1/25/2019 - Paper - English - AAMI
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    €294.32

  • AAMI TIR38:2019

    Medical device safety assurance case report guidance
    1/25/2019 - PDF - English - AAMI
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    €249.08

  • AAMI/ISO 11607-1: 2019

    Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
    1/1/2019 - Paper - English - AAMI
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    €210.08

  • AAMI/ISO 11607-1: 2019

    Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
    1/1/2019 - PDF - English - AAMI
    Learn More
    €166.05

  • AAMI/ISO 11607-2: 2019

    Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
    1/1/2019 - Paper - English - AAMI
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    €163.28

  • AAMI/ISO 11607-2: 2019

    Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
    1/1/2019 - PDF - English - AAMI
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    €134.28

  • AAMI SW91:2018

    Classification of defects in health software
    11/2/2018 - Paper - English - AAMI
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    €294.32

  • AAMI SW91:2018

    Classification of defects in health software
    11/2/2018 - PDF - English - AAMI
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    €249.08

  • AAMI TIR68:2018

    Low and intermediate-level disinfection in healthcare settings for medical devices and patient care equipment and sterile processing environmental surfaces
    9/30/2018 - Paper - English - AAMI
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    €195.52

  • AAMI/IEC 60601-2-20:2009 (R2014) & A1:2016

    Medical Electrical Equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators
    9/1/2018 - PDF - English - AAMI
    Learn More
    €233.70

  • AAMI/IEC 60601-2-19:2009 (R2014) & A1:2016

    Medical Electrical Equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators
    9/1/2018 - PDF - English - AAMI
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    €205.00

  • AAMI/IEC 60601-2-21:2009 (R2014) & A1:2016

    Medical Electrical Equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers
    9/1/2018 - PDF - English - AAMI
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    €205.00

  • AAMI/ISO TI(R2190)0:2018

    Guidance for uncertainty analysis regarding the application of ISO/TS 10974
    7/19/2018 - Paper - English - AAMI
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    €163.28

  • AAMI/ISO TI(R2190)0:2018

    Guidance for uncertainty analysis regarding the application of ISO/TS 10974
    7/19/2018 - PDF - English - AAMI
    Learn More
    €134.28

  • AAMI TIR77:2018

    Technical Information Report Sorbent-based regenerative hemodialysis systems
    6/8/2018 - Paper - English - AAMI
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    €195.52

  • AAMI TIR77:2018

    Technical Information Report Sorbent-based regenerative hemodialysis systems
    6/8/2018 - PDF - English - AAMI
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    €166.05

  • AAMI/ISO TI(R1097)4:2018

    Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device
    5/1/2018 - Paper - English - AAMI
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    €372.32

  • AAMI/ISO TI(R1097)4:2018

    Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device
    5/1/2018 - PDF - English - AAMI
    Learn More
    €309.55

  • AAMI TIR67:2018

    Promoting safe practices pertaining to the use of sterilant and disinfectant chemicals in health care facilities
    4/25/2018 - Paper - English - AAMI
    Learn More
    €294.32

  • AAMI TIR67:2018

    Promoting safe practices pertaining to the use of sterilant and disinfectant chemicals in health care facilities
    4/25/2018 - PDF - English - AAMI
    Learn More
    €249.08

  • AAMI TIR40:2018

    Sterilization of health care products - Radiation - Guidance on dose setting utilizing a Modified Method 2
    1/31/2018 - Paper - English - AAMI
    Learn More
    €195.52

  • AAMI TIR40:2018

    Sterilization of health care products - Radiation - Guidance on dose setting utilizing a Modified Method 2
    1/31/2018 - PDF - English - AAMI
    Learn More
    €166.05

  • AAMI/ISO 11737-1:2018

    Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products
    1/24/2018 - Paper - English - AAMI
    Learn More
    €221.52

  • AAMI/ISO 11737-1:2018

    Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products
    1/24/2018 - PDF - English - AAMI
    Learn More
    €177.33

  • ANSI/AAMI/IEC 80601-2-30:2018

    Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
    1/1/2018 - PDF sécurisé - English - AAMI
    Learn More
    €228.42

  • AAMI/ISO 13408-2:2018

    Aseptic processing of health care products - Part 2: Sterilizing filtration
    1/1/2018 - PDF sécurisé - English - AAMI
    Learn More
    €113.16

  • AAMI/ISO 11737-1:2018

    AAMI/ISO CDV-3 11737-1, Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on product
    1/1/2018 - PDF sécurisé - English - AAMI
    Learn More
    €154.56

  • AAMI TIR16:2017

    162
    11/17/2017 - Paper - English - AAMI
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    €195.52

  • AAMI TIR16:2017

    162
    11/17/2017 - PDF - English - AAMI
    Learn More
    €166.05

  • AAMI/ISO 13408-2:2018

    Aseptic processing of health care products - Part 2:Sterilizing filtration
    11/17/2017 - Paper - English - AAMI
    Learn More
    €163.28

  • AAMI/ISO 13408-2:2018

    Aseptic processing of health care products - Part 2:Sterilizing filtration
    11/17/2017 - PDF - English - AAMI
    Learn More
    €134.28

  • AAMI/ISO 11137-3:2017

    Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine
    10/6/2017 - Paper - English - AAMI
    Learn More
    €163.28

  • AAMI/ISO 11137-3:2017

    Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine
    10/6/2017 - PDF - English - AAMI
    Learn More
    €134.28

  • AAMI ST79:2017

    Comprehensive guide to steam sterilization and sterility assurance in health care facilities
    10/1/2017 - Paper - English - AAMI
    Learn More
    €482.56

  • AAMI ST79:2017

    Comprehensive guide to steam sterilization and sterility assurance in health care facilities
    10/1/2017 - PDF - English - AAMI
    Learn More
    €418.20

  • AAMI/ISO 80369-7:2016

    Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications
    9/27/2017 - Paper - English - AAMI
    Learn More
    €294.32

  • AAMI/ISO 80369-7:2016

    Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications
    9/27/2017 - PDF - English - AAMI
    Learn More
    €249.08

  • AAMI TIR72:2017

    Dialysis fluid chemical composition
    9/8/2017 - Paper - English - AAMI
    Learn More
    €163.28

  • AAMI TIR72:2017

    Dialysis fluid chemical composition
    9/8/2017 - PDF - English - AAMI
    Learn More
    €134.28

  • AAMI/ISO TI(R1549)9:2017

    Biological evaluation of medical devices - Guidance on the conduct of biological evaluation within a risk management process
    8/27/2017 - Paper - English - AAMI
    Learn More
    €190.32

  • AAMI/ISO TI(R1549)9:2017

    Biological evaluation of medical devices - Guidance on the conduct of biological evaluation within a risk management process
    8/27/2017 - PDF - English - AAMI
    Learn More
    €160.93

  • AAMI/ISO 17664:2017

    Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices.
    8/18/2017 - Paper - English - AAMI
    Learn More
    €235.04

  • AAMI/ISO 17664:2017

    Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices.
    8/18/2017 - PDF - English - AAMI
    Learn More
    €205.00

  • AAMI/ISO TIR80002-2:2017

    Medical device software - Part 2: Validation of software for medical device quality systems
    8/18/2017 - PDF - English, French - AAMI
    Learn More
    €289.05

  • AAMI TIR71:2017

    Guidance for logging of alarm system data
    8/11/2017 - Paper - English - AAMI
    Learn More
    €163.28

  • AAMI TIR71:2017

    Guidance for logging of alarm system data
    8/11/2017 - PDF - English - AAMI
    Learn More
    €134.28

  • AAMI TIR59:2017

    Integrating human factors into design controls
    8/4/2017 - Paper - English - AAMI
    Learn More
    €235.04

  • AAMI TIR59:2017

    Integrating human factors into design controls
    8/4/2017 - PDF - English - AAMI
    Learn More
    €205.00

  • AAMI/ISO 11138-1:2017

    Sterilization of health care products - Biological indicators - Part 1: General requirements
    8/1/2017 - Paper - English - AAMI
    Learn More
    €294.32

  • AAMI/ISO 11138-1:2017

    Sterilization of health care products - Biological indicators - Part 1: General requirements
    8/1/2017 - PDF - English - AAMI
    Learn More
    €249.08

  • AAMI/ISO 11138-5:2017

    Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes
    8/1/2017 - Paper - English - AAMI
    Learn More
    €145.60

  • AAMI/ISO 11138-5:2017

    Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes
    8/1/2017 - PDF - English - AAMI
    Learn More
    €116.85

  • AAMI/ISO 11138-2:2017

    Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes
    8/1/2017 - Paper - English - AAMI
    Learn More
    €145.60

  • AAMI/ISO 11138-2:2017

    Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes
    8/1/2017 - PDF - English - AAMI
    Learn More
    €116.85

  • AAMI/ISO 11138-4:2017

    Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization processes
    8/1/2017 - Paper - English - AAMI
    Learn More
    €145.60

  • AAMI/ISO 11138-4:2017

    Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization processes
    8/1/2017 - PDF - English - AAMI
    Learn More
    €116.85

  • AAMI/ISO 11138-3:2017

    Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes
    8/1/2017 - Paper - English - AAMI
    Learn More
    €145.60

  • AAMI/ISO 11138-3:2017

    Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes
    8/1/2017 - PDF - English - AAMI
    Learn More
    €116.85

  • AAMI/ISO 16142-2:2017

    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
    7/31/2017 - Paper - English - AAMI
    Learn More
    €294.32

  • AAMI/ISO 16142-2:2017

    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
    7/31/2017 - PDF - English - AAMI
    Learn More
    €249.08

  • AAMI ST90:2017

    Processing of health care products - Quality management systems for processing in health care facilities
    7/18/2017 - Paper - English - AAMI
    Learn More
    €278.72

  • AAMI ST90:2017

    Processing of health care products - Quality management systems for processing in health care facilities
    7/18/2017 - PDF - English - AAMI
    Learn More
    €233.70

  • AAMI/IEC 60601-2-2:2017

    Medical electrical equipment - Part 2-2: Particular requirements for basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
    6/30/2017 - PDF - English - AAMI
    Learn More
    €249.08

  • AAMI TIR17:2017

    Compatibility of materials subject to sterilization
    6/11/2017 - Paper - English - AAMI
    Learn More
    €327.60

  • AAMI TIR17:2017

    Compatibility of materials subject to sterilization
    6/11/2017 - PDF - English - AAMI
    Learn More
    €265.48

  • AAMI TIR21:2017

    Systems Used to Forecast Remaining Pacemaker Battery Service Life
    6/11/2017 - Paper - English - AAMI
    Learn More
    €287.04

  • AAMI TIR21:2017

    Systems Used to Forecast Remaining Pacemaker Battery Service Life
    6/11/2017 - PDF - English - AAMI
    Learn More
    €241.90

  • AAMI/ISO 25539-1:2017

    Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses
    5/25/2017 - Paper - English - AAMI
    Learn More
    €266.24

  • AAMI/ISO 25539-1:2017

    Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses
    5/25/2017 - PDF - English - AAMI
    Learn More
    €205.00

  • AAMI TIR69:2017

    Risk Management of Radio-Frequency Wireless Coexistence for Medical Devices and Systems
    4/28/2017 - Paper - English - AAMI
    Learn More
    €294.32

  • AAMI TIR69:2017

    Risk Management of Radio-Frequency Wireless Coexistence for Medical Devices and Systems
    4/28/2017 - PDF - English - AAMI
    Learn More
    €249.08

  • AAMI/ISO 14708-3:2017

    Implants for surgery - Active implantable medical devices - Part 3: Implantable neurostimulators
    3/2/2017 - Paper - English - AAMI
    Learn More
    €278.72

  • AAMI/ISO 14708-3:2017

    Implants for surgery - Active implantable medical devices - Part 3: Implantable neurostimulators
    3/2/2017 - PDF - English - AAMI
    Learn More
    €233.70

  • AAMI TIR66:2017

    Guidance for the creation of physiologic data and waveform databases to demonstrate reasonable assurance of the safety and effectiveness of alarm system algorithms
    2/28/2017 - Paper - English - AAMI
    Learn More
    €235.04

  • AAMI TIR66:2017

    Guidance for the creation of physiologic data and waveform databases to demonstrate reasonable assurance of the safety and effectiveness of alarm system algorithms
    2/28/2017 - PDF - English - AAMI
    Learn More
    €205.00

  • ANSI/AAMI/ISO 10993-6:2016

    Biological evaluation of medical devices - Part 6: Tests for local effects after implantation
    1/10/2017 - Paper - English - AAMI
    Learn More
    €195.52

  • ANSI/AAMI/ISO 10993-6:2016

    Biological evaluation of medical devices - Part 6: Tests for local effects after implantation
    1/10/2017 - PDF - English - AAMI
    Learn More
    €166.05

  • AAMI CI86:2017

    Cochlear implant systems: Requirements for safety, functional verification, labeling and reliability reporting
    1/6/2017 - Paper - English - AAMI
    Learn More
    €351.52

  • AAMI CI86:2017

    Cochlear implant systems: Requirements for safety, functional verification, labeling and reliability reporting
    1/6/2017 - PDF - English - AAMI
    Learn More
    €289.05

  • AAMI/ISO 14708-3:2017

    Implants for surgery - Active implantable medical devices - Part 3: Implantable neurostimulators
    1/1/2017 - PDF sécurisé - English - AAMI
    Learn More
    €191.36

  • AAMI/ISO 25539-1:2017

    Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses
    1/1/2017 - PDF sécurisé - English - AAMI
    Learn More
    €237.36

  • 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
    1/1/2017 - PDF sécurisé - English - AAMI
    Learn More
    €237.36

  • AAMI/ISO 11138-3:2017

    Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes
    1/1/2017 - PDF sécurisé - English - AAMI
    Learn More
    €109.48

  • AAMI/ISO 11138-2:2017

    Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes
    1/1/2017 - PDF sécurisé - English - AAMI
    Learn More
    €109.48

  • AAMI/ISO 11138-4:2017

    Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization processes
    1/1/2017 - PDF sécurisé - English - AAMI
    Learn More
    €109.48

  • AAMI/ISO 11138-5:2017

    Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes
    1/1/2017 - PDF sécurisé - English - AAMI
    Learn More
    €109.48

  • AAMI/ISO 15223-1:2016

    Medical devices - Symbols to be used with medical device labels, labeling, and information to be supplied - Part 1: General requirements
    12/15/2016 - Paper - English - AAMI
    Learn More
    €195.52

  • AAMI/ISO 15223-1:2016

    Medical devices - Symbols to be used with medical device labels, labeling, and information to be supplied - Part 1: General requirements
    12/15/2016 - PDF - English - AAMI
    Learn More
    €166.05

  • AAMI TIR15:2016

    Physical aspects of ethylene oxide sterilization
    11/18/2016 - Paper - English - AAMI
    Learn More
    €195.52

  • AAMI TIR15:2016

    Physical aspects of ethylene oxide sterilization
    11/18/2016 - PDF - English - AAMI
    Learn More
    €166.05

  • 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
    11/18/2016 - Paper - English - AAMI
    Learn More
    €336.96

  • 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
    11/18/2016 - PDF - English - AAMI
    Learn More
    €249.08

  • AAMI/ISO 7199:2016

    Cardiovascular Implants and Artificial Organs - Blood-Gas Exchangers (Oxygenators)
    11/18/2016 - Paper - English - AAMI
    Learn More
    €163.28

  • AAMI/ISO 7199:2016

    Cardiovascular Implants and Artificial Organs - Blood-Gas Exchangers (Oxygenators)
    11/18/2016 - PDF - English - AAMI
    Learn More
    €134.28

  • AAMI/ISO 15676:2016

    Cardiovascular implants and artificial organs - Requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO)
    11/18/2016 - Paper - English - AAMI
    Learn More
    €163.28

  • AAMI/ISO 15675:2016

    Cardiovascular implants and artificial organs - Cardiopulmonary bypass systems - Arterial blood line filters
    11/18/2016 - Paper - English - AAMI
    Learn More
    €145.60

  • AAMI/ISO 15675:2016

    Cardiovascular implants and artificial organs - Cardiopulmonary bypass systems - Arterial blood line filters
    11/18/2016 - PDF - English - AAMI
    Learn More
    €116.85

  • AAMI/ISO 18242:2016

    Cardiovascular implants and extracorporeal systems - Cardiopulmonary bypass systems - Venous bubble traps
    11/18/2016 - Paper - English - AAMI
    Learn More
    €163.28

  • AAMI/ISO 18242:2016

    Cardiovascular implants and extracorporeal systems - Cardiopulmonary bypass systems - Venous bubble traps
    11/18/2016 - PDF - English - AAMI
    Learn More
    €134.28

  • AAMI TIR28:2016

    Product adoption and process equivalency for ethylene oxide sterilization
    11/18/2016 - Paper - English - AAMI
    Learn More
    €163.28

  • AAMI TIR28:2016

    Product adoption and process equivalency for ethylene oxide sterilization
    11/18/2016 - PDF - English - AAMI
    Learn More
    €134.28

  • AAMI/ISO 15676:2016

    Cardiovascular implants and artificial organs - Requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO)
    11/18/2016 - PDF - English - AAMI
    Learn More
    €134.28

  • AAMI/ISO 22442-1:2016

    Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management
    11/17/2016 - Paper - English - AAMI
    Learn More
    €206.96

  • AAMI/ISO 22442-1:2016

    Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management
    11/17/2016 - PDF - English - AAMI
    Learn More
    €177.33

  • AAMI/ISO 22442-2:2016

    Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling
    11/17/2016 - Paper - English - AAMI
    Learn More
    €163.28

  • AAMI/ISO 22442-2:2016

    Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling
    11/17/2016 - PDF - English - AAMI
    Learn More
    €134.28

  • AAMI/ISO 15674:2016

    Cardiovascular implants and artificial organs - Hard shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags
    11/16/2016 - Paper - English - AAMI
    Learn More
    €145.60

  • AAMI/ISO 15674:2016

    Cardiovascular implants and artificial organs - Hard shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags
    11/16/2016 - PDF - English - AAMI
    Learn More
    €116.85

  • AAMI/ISO 18241:2016

    Cardiovascular implants and extracorporeal systems - Cardiopulmonary bypass systems - Venous bubble traps
    11/7/2016 - Paper - English - AAMI
    Learn More
    €195.52

  • AAMI/ISO 18241:2016

    Cardiovascular implants and extracorporeal systems - Cardiopulmonary bypass systems - Venous bubble traps
    11/7/2016 - PDF - English - AAMI
    Learn More
    €166.05

  • AAMI ST55:2016

    Table-Top Steam Sterilizers
    11/1/2016 - Paper - English - AAMI
    Learn More
    €235.04

  • AAMI ST55:2016

    Table-Top Steam Sterilizers
    11/1/2016 - PDF - English - AAMI
    Learn More
    €205.00

  • AAMI/ISO TI(R1902)4:2016

    Evaluation of CPB devices relative to their capabilities of reducing the transmition of gaseous microemboli (GME) to a patient during cardiopulmonary bypass
    10/9/2016 - Paper - English - AAMI
    Learn More
    €195.52

  • AAMI/ISO TI(R1902)4:2016

    Evaluation of CPB devices relative to their capabilities of reducing the transmition of gaseous microemboli (GME) to a patient during cardiopulmonary bypass
    10/9/2016 - PDF - English - AAMI
    Learn More
    €166.05

  • AAMI/IEC TIR80002-3:2016

    Technical Information Report Medical device software - Part 3: Process reference model of medical device software life cycle processes (IEC 62304)
    8/12/2016 - Paper - English, French - AAMI
    Learn More
    €277.68

  • AAMI/IEC TIR80002-3:2016

    Technical Information Report Medical device software - Part 3: Process reference model of medical device software life cycle processes (IEC 62304)
    8/12/2016 - PDF - English, French - AAMI
    Learn More
    €205.00

  • AAMI/ISO 16142-1:2016

    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
    8/10/2016 - Paper - English - AAMI
    Learn More
    €294.32

  • AAMI/ISO 16142-1:2016

    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
    8/10/2016 - PDF - English - AAMI
    Learn More
    €249.08

  • AAMI TIR74:2016

    Change summary for ISO 11135:2014, Sterilization of health care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
    8/9/2016 - Paper - English - AAMI
    Learn More
    €163.28

  • AAMI TIR74:2016

    Change summary for ISO 11135:2014, Sterilization of health care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
    8/9/2016 - PDF - English - AAMI
    Learn More
    €134.28

  • AAMI/ISO 80369-6:2016

    Small-bore connectors for liquids and gases in healthcare applications - Part 6: Connectors for neuraxial applications
    8/4/2016 - Paper - English - AAMI
    Learn More
    €294.32

  • AAMI/ISO 80369-6:2016

    Small-bore connectors for liquids and gases in healthcare applications - Part 6: Connectors for neuraxial applications
    8/4/2016 - PDF - English - AAMI
    Learn More
    €249.08

  • AAMI/ISO 80369-5:2016

    Small-bore connectors for liquids and gases in healthcare applications - Part 5: Connectors for limb cuff inflation applications
    8/4/2016 - Paper - English - AAMI
    Learn More
    €235.04

  • AAMI/ISO 80369-5:2016

    Small-bore connectors for liquids and gases in healthcare applications - Part 5: Connectors for limb cuff inflation applications
    8/4/2016 - PDF - English - AAMI
    Learn More
    €205.00

  • AAMI TIR57:2016

    Principles for medical device security - Risk management
    8/3/2016 - Paper - English - AAMI
    Learn More
    €334.88

  • AAMI TIR57:2016

    Principles for medical device security - Risk management
    8/3/2016 - PDF - English - AAMI
    Learn More
    €289.05

  • AAMI/ISO 7198:2016

    Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches
    8/2/2016 - Paper - English - AAMI
    Learn More
    €294.32

  • AAMI/ISO 7198:2016

    Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches
    8/2/2016 - PDF - English - AAMI
    Learn More
    €249.08

  • AAMI TIR14:2016

    Contract sterilization using ethylene oxide
    6/5/2016 - Paper - English - AAMI
    Learn More
    €163.28

  • AAMI TIR14:2016

    Contract sterilization using ethylene oxide
    6/5/2016 - PDF - English - AAMI
    Learn More
    €134.28

  • AAMI TIR35:2016

    Sterilization of health care products - Radiation sterilization - Product adoption and alternative sampling plans for verification dose experiments and sterilization dose audits
    6/5/2016 - Paper - English - AAMI
    Learn More
    €235.04

  • AAMI TIR35:2016

    Sterilization of health care products - Radiation sterilization - Product adoption and alternative sampling plans for verification dose experiments and sterilization dose audits
    6/5/2016 - PDF - English - AAMI
    Learn More
    €205.00

  • AAMI/ISO 80369-3:2016

    Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications
    6/5/2016 - Paper - English - AAMI
    Learn More
    €294.32

  • AAMI/ISO 80369-3:2016

    Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications
    6/5/2016 - PDF - English - AAMI
    Learn More
    €249.08

  • AAMI/IEC 62304:2006/A1:2016

    Medical device software - Software life cycle processes, Amendment 1
    4/7/2016 - Paper - English - AAMI
    Learn More
    €300.56

  • AAMI/IEC 62304:2006/A1:2016

    Medical device software - Software life cycle processes, Amendment 1
    4/7/2016 - PDF - English - AAMI
    Learn More
    €213.20

  • AAMI/IEC 62304:2006 & A1:2016

    Medical device software - Software life cycle processes - Consolidated Text
    4/7/2016 - Paper - English - AAMI
    Learn More
    €336.96

  • AAMI/IEC 62304:2006 & A1:2016

    Medical device software - Software life cycle processes - Consolidated Text
    4/7/2016 - PDF - English - AAMI
    Learn More
    €249.08

  • AAMI/ISO 13485:2016(R2019)

    Medical devices - Quality management systems - Requirements for regulatory purposes
    3/25/2016 - Paper - English - AAMI
    Learn More
    €294.32

  • AAMI/ISO 13485:2016(R2019)

    Medical devices - Quality management systems - Requirements for regulatory purposes
    3/25/2016 - PDF - English - AAMI
    Learn More
    €249.08

  • Checklist for ISO 13485:2016, Medical Devices - Quality Management Systems- Requ

    Test methods for electrical steel strip and sheet -- Part 3: Methods of measurement of the magnetic properties of electrical steel strip and sheet at medium frequencies
    3/1/2016 - Paper - English - AAMI
    Learn More
    €213.20

  • Checklist for ISO 13485:2016, Medical Devices - Quality Management Systems- Requ

    Test methods for electrical steel strip and sheet -- Part 3: Methods of measurement of the magnetic properties of electrical steel strip and sheet at medium frequencies
    3/1/2016 - PDF - English - AAMI
    Learn More
    €306.48

  • AAMI/IEC TIR60878:2015

    Graphical Symbols for Electrical Equipment in Medical Practice
    1/3/2016 - Paper - English, French - AAMI
    Learn More
    €537.68

  • AAMI/IEC TIR60878:2015

    Graphical Symbols for Electrical Equipment in Medical Practice
    1/3/2016 - PDF - English, French - AAMI
    Learn More
    €446.90

  • AAMI TIR65:2015

    Sustainability of medical devices--Elements of a responsible product life cycle
    1/1/2016 - Paper - English - AAMI
    Learn More
    €264.16

  • AAMI TIR65:2015

    Sustainability of medical devices--Elements of a responsible product life cycle
    1/1/2016 - PDF - English - AAMI
    Learn More
    €233.70

  • AAMI/ISO 80369-6:2016

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

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