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AAMI

187 article(s)

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  • AAMI TIR17:2017

    Compatibility of materials subject to sterilization
    01/05/2018 - PDF - Anglais - AAMI
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    257,28 €

  • AAMI TIR45:2012/(R)2018 (R2018)

    Guidance on the use of agile practices in the development of medical device software
    05/04/2018 - PDF - Anglais - AAMI
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    236,00 €

  • 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
    01/01/2018 - PDF sécurisé - Anglais - AAMI
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    154,56 €

  • AAMI/ISO 13408-2:2018

    Aseptic processing of health care products - Part 2: Sterilizing filtration
    01/01/2018 - PDF sécurisé - Anglais - AAMI
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    113,16 €

  • AAMI Standards online

    AAMI Standards online
    01/01/2018 - CD-Rom - Anglais - AAMI
    En savoir plus
    1 798,60 €

  • AAMI TIR16:2017

    Microbiological aspects of ethylene oxide sterilization
    17/11/2017 - PDF - Anglais - AAMI
    En savoir plus
    157,00 €

  • AAMI TIR69:2017

    Risk Management of Radio-Frequency Wireless Coexistence for Medical Devices and Systems
    28/04/2017 - PDF - Anglais - AAMI
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    236,00 €

  • AAMI/ISO 14708-3:2017

    Implants for surgery - Active implantable medical devices - Part 3: Implantable neurostimulators
    01/01/2017 - PDF sécurisé - Anglais - AAMI
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    191,36 €

  • AAMI CI 86:2017

    Cochlear implant systems - Safety, performance and reliability
    01/01/2017 - PDF sécurisé - Anglais - AAMI
    En savoir plus
    237,36 €

  • AAMI/ISO 25539-1:2017

    Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses
    01/01/2017 - PDF sécurisé - Anglais - AAMI
    En savoir plus
    237,36 €

  • AAMI/ISO 10993-6:2017

    Biological evaluation of medical devices -- Part 6: Tests for local effects after implantation
    01/01/2017 - PDF sécurisé - Anglais - AAMI
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    136,16 €

  • 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 sécurisé - Anglais - AAMI
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    237,36 €

  • AAMI ST 90:2017

    Processing of health care products - Quality management systems for processing in health care facilities
    01/01/2017 - PDF sécurisé - Anglais - AAMI
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    191,36 €

  • AAMI ST 79:2017

    Guide complet stérilisation à la vapeur et l'assurance de la stérilité dans les établissements de soins de santé
    01/01/2017 - PDF sécurisé - Anglais - AAMI
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    364,32 €

  • 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
    01/01/2017 - PDF sécurisé - Anglais - AAMI
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    204,24 €

  • AAMI/ISO 17664:2017

    Sterilization of health care products - Information to be provided by the device manufacturer for the processing of medical devices
    01/01/2017 - PDF sécurisé - Anglais - AAMI
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    168,36 €

  • AAMI/ISO 11138-4:2017

    Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization processes
    01/01/2017 - PDF sécurisé - Anglais - AAMI
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    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
    01/01/2017 - PDF sécurisé - Anglais - AAMI
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    109,48 €

  • AAMI/ISO 11138-1:2017

    Sterilization of health care products - Biological indicators - Part 1: General requirements
    01/01/2017 - PDF sécurisé - Anglais - AAMI
    En savoir plus
    191,36 €

  • AAMI/ISO 11138-3:2017

    Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes
    01/01/2017 - PDF sécurisé - Anglais - AAMI
    En savoir plus
    109,48 €

  • AAMI/ISO 11138-2:2017

    Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes
    01/01/2017 - PDF sécurisé - Anglais - AAMI
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    109,48 €

  • AAMI/ISO 11137-3:2017

    Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control
    01/01/2017 - PDF sécurisé - Anglais - AAMI
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    168,36 €

  • AAMI TIR15:2016

    Physical aspects of ethylene oxide sterilization
    18/11/2016 - PDF - Anglais - AAMI
    En savoir plus
    157,00 €

  • AAMI TIR28:2016

    Product adoption and process equivalency for ethylene oxide sterilization
    18/11/2016 - PDF - Anglais - AAMI
    En savoir plus
    127,00 €

  • AAMI TIR57:2016

    Principles for medical device security - Risk management
    05/06/2016 - PDF - Anglais - AAMI
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    274,00 €

  • 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 sécurisé - Anglais - AAMI
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    204,24 €

  • AAMI/IEC 62304 AMD 1:2016

    Medical device software - Software life cycle processes, Amendment 1
    01/01/2016 - PDF sécurisé - Anglais - AAMI
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    191,36 €

  • AAMI/ISO 15223-2:2016

    Medical devices - Symbols to be used with medical device labels, labeling and information to be supplied - Part 2: Symbol development, selection and validation
    01/01/2016 - PDF sécurisé - Anglais - AAMI
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    109,48 €

  • AAMI/ISO 13485:2016

    Medical devices - Quality management systems - Requirements for regulatory purposes
    01/01/2016 - PDF sécurisé - Anglais - AAMI
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    204,24 €

  • AAMI/ISO 80369-5:2016

    Small-bore connectors for liquids and gases in healthcare application - Part 5: Connectors for limb cuff inflation applications
    01/01/2016 - PDF sécurisé - Anglais - AAMI
    En savoir plus
    168,36 €

  • 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
    01/01/2016 - PDF sécurisé - Anglais - AAMI
    En savoir plus
    204,24 €

  • 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 and medical electrical systems intended for use in the emergency medical services environment
    01/01/2016 - PDF sécurisé - Anglais - AAMI
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    204,24 €

  • 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 sécurisé - Anglais - AAMI
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    204,24 €

  • AAMI/ISO 18242:2016

    Cardiovascular implants and extracorporeal systems - Centrifugal blood pumps
    01/01/2016 - PDF sécurisé - Anglais - AAMI
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    109,48 €

  • AAMI/ISO 18241:2016

    Cardiovascular implants and extracorporeal systems - Cardiopulmonary bypass systems - Venous bubble traps
    01/01/2016 - PDF sécurisé - Anglais - AAMI
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    136,16 €

  • AAMI/ISO 15674:2016

    Cardiovascular implants and artificial organs - Hardshell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags
    01/01/2016 - PDF sécurisé - Anglais - AAMI
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    95,68 €

  • AAMI/ISO 15675:2016

    Cardiovascular implants and artificial organs - Cardiopulmonary bypass systems - Arterial blood line filters
    01/01/2016 - PDF sécurisé - Anglais - AAMI
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    95,68 €

  • 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 sécurisé - Anglais - AAMI
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    109,48 €

  • 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 sécurisé - Anglais - AAMI
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    109,48 €

  • AAMI/ISO 22442-1:2016

    Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management
    01/01/2016 - PDF sécurisé - Anglais - AAMI
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    168,36 €

  • AAMI/IEC 60601-2-21/A1:2016

    Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers, Amendment 1
    01/01/2016 - PDF sécurisé - Anglais - AAMI
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    109,48 €

  • AAMI/IEC 60601-2-20/A1:2016

    Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of transport infant incubators, Amendment 1
    01/01/2016 - PDF sécurisé - Anglais - AAMI
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    109,48 €

  • AAMI/ISO 7198:2016

    Cardiovascular implants and extracorporeal systems - Vascular Prostheses - Tubular vascular grafts and vascular patches
    01/01/2016 - PDF sécurisé - Anglais - AAMI
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    204,24 €

  • AAMI/IEC 80601-2-58/A1:2016

    Medical electrical equipment - Part 2-58: Particular requirements for the basic safety and essential performance of lens removal and vitrectomy devices for ophthalmic surgery (Amendment 1)
    01/01/2016 - PDF sécurisé - Anglais - AAMI
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    109,48 €

  • AAMI/IEC 60601-2-50/A1:2016

    Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment, Amendment 1
    01/01/2016 - PDF sécurisé - Anglais - AAMI
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    95,68 €

  • AAMI ST 55:2016

    Table-top steam sterilizers
    01/01/2016 - PDF sécurisé - Anglais - AAMI
    En savoir plus
    168,36 €

  • AAMI/ISO 7199:2016

    Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators)
    01/01/2016 - PDF sécurisé - Anglais - AAMI
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    109,48 €

  • AAMI/ISO 80369-7:2016

    Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors with 6% (Luer) taper for intravascular or hypodermic applications
    01/01/2016 - PDF sécurisé - Anglais - AAMI
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    204,24 €

  • AAMI/ISO 15223-1:2016 (R2017)

    Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
    01/01/2016 - PDF sécurisé - Anglais - AAMI
    En savoir plus
    168,36 €

  • AAMI/IEC 80601-2-35/A1:2016

    Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads and mattresses intended for heating in medical use, Amendment 1
    01/01/2016 - PDF sécurisé - Anglais - AAMI
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    95,68 €

  • AAMI/IEC 60601-2-19/A1:2016

    Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators, Amendment 1
    01/01/2016 - PDF sécurisé - Anglais - AAMI
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    109,48 €

  • AAMI EQ 89:2015

    Guidance for the use of medical equipment maintenance strategies and procedures
    01/01/2015 - PDF sécurisé - Anglais - AAMI
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    109,48 €

  • AAMI/IEC 62366-1:2015

    Medical devices - Application of usability Engineering to medical devices
    01/01/2015 - PDF sécurisé - Anglais - AAMI
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    191,36 €

  • AAMI/ISO 80369-20:2015

    Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods
    01/01/2015 - PDF sécurisé - Anglais - AAMI
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    191,36 €

  • AAMI ST 91:2015

    Flexible and semi-rigid endoscope reprocessing in health care facilities
    01/01/2015 - PDF sécurisé - Anglais - AAMI
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    204,24 €

  • ANSI/AAMI/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
    01/01/2015 - PDF sécurisé - Anglais - AAMI
    En savoir plus
    252,08 €

  • AAMI HA 60601-1-11:2015

    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 sécurisé - Anglais - AAMI
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    285,20 €

  • AAMI/ISO 5840-2:2015

    Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes
    01/01/2015 - PDF sécurisé - Anglais - AAMI
    En savoir plus
    204,24 €

  • AAMI/ISO 12417-1:2015

    Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 1: General requirements
    01/01/2015 - PDF sécurisé - Anglais - AAMI
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    204,24 €

  • AAMI/ISO 5840-1:2015

    Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements
    01/01/2015 - PDF sécurisé - Anglais - AAMI
    En savoir plus
    204,24 €

  • AAMI/ISO 23747:2015

    Anaesthetic and respiratory equipment - Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans
    01/01/2015 - PDF sécurisé - Anglais - AAMI
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    126,96 €

  • AAMI/ISO 5367:2015

    Anaesthetic and respiratory equipment - Breathing sets and connectors
    01/01/2015 - PDF sécurisé - Anglais - AAMI
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    191,36 €

  • AAMI/ISO 26782:2015

    Anaesthetic and respiratory equipment - Spirometers intended for the measurement of time forced expired volumes in humans
    01/01/2015 - PDF sécurisé - Anglais - AAMI
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    168,36 €

  • AAMI/ISO 8836:2015

    Suction catheters for use in the respiratory tract
    01/01/2015 - PDF sécurisé - Anglais - AAMI
    En savoir plus
    168,36 €

  • AAMI Standards - Dialysis (PDF Format)

    The 2015 collection consists of 11 AAMI Hemodialysis standards, six of which were published in 2014
    01/01/2015 - PDF sécurisé - Anglais - AAMI
    En savoir plus
    497,72 €

  • AAMI TIR34:2014

    Water for the reprocessing of medical devices
    08/04/2014 - PDF sécurisé - Anglais - AAMI
    En savoir plus
    204,24 €

  • AAMI TIR52:2014/(R)2017

    Environmental Monitoring For Terminally Sterilized Healthcare Products
    10/03/2014 - PDF - Anglais - AAMI
    En savoir plus
    111,00 €

  • AAMI ST 15883-1/A1:2014

    Washer-disinfectors - Part 1: General requirements, terms and definitions and tests - Amendment 1
    01/01/2014 - PDF sécurisé - Anglais - AAMI
    En savoir plus
    204,24 €

  • AAMI/ISO 5841-2:2014

    Implants for surgery - Cardiac pacemakers - Part 2: Reporting of clinical performance of populations of pulse generators or leads
    01/01/2014 - PDF sécurisé - Anglais - AAMI
    En savoir plus
    136,16 €

  • AAMI 13958:2014

    Concentrates for haemodialysis and related therapies
    01/01/2014 - PDF sécurisé - Anglais - AAMI
    En savoir plus
    136,16 €

  • AAMI 11663:2014

    Quality of dialysis fluid for haemodialysis and related therapies
    01/01/2014 - PDF sécurisé - Anglais - AAMI
    En savoir plus
    109,48 €

  • AAMI 13959:2014

    Water for haemodialysis and related therapies
    01/01/2014 - PDF sécurisé - Anglais - AAMI
    En savoir plus
    109,48 €

  • AAMI 26722:2014

    Water treatment equipment for haemodialysis applications and related therapies
    01/01/2014 - PDF sécurisé - Anglais - AAMI
    En savoir plus
    168,36 €

  • AAMI 23500:2014

    Guidance for the preparation and quality management of fluids for haemodialysis and related therapies
    01/01/2014 - PDF sécurisé - Anglais - AAMI
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    237,36 €

  • AAMI/ISO 11607-1 AMD 1:2014

    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
    01/01/2014 - PDF sécurisé - Anglais - AAMI
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    58,88 €

  • AAMI/ISO 10993-3:2014

    Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
    01/01/2014 - PDF sécurisé - Anglais - AAMI
    En savoir plus
    109,48 €

  • AAMI/ISO 11140-1:2014

    Sterilization of health care products - Chemical indicators - Part 1: General requirements
    01/01/2014 - PDF sécurisé - Anglais - AAMI
    En savoir plus
    136,16 €

  • AAMI/IEC 80601-2-58:2014

    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
    01/01/2014 - PDF sécurisé - Anglais - AAMI
    En savoir plus
    136,16 €

  • 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 sécurisé - Anglais - AAMI
    En savoir plus
    204,24 €

  • AAMI/ISO 11607-1/A1:2014 (R2016)

    Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging
    01/01/2014 - PDF sécurisé - Anglais - AAMI
    En savoir plus
    55,20 €

  • AAMI/ISO 11607-2 AMD 1:2014 (R2016)

    Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
    01/01/2014 - PDF sécurisé - Anglais - AAMI
    En savoir plus
    58,88 €

  • AAMI ST77:2013/(R)2018 (R2018)

    Containment devices for reusable medical device sterilization
    01/02/2013 - PDF - Anglais - AAMI
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    157,00 €

  • AAMI ST 15883-2:2013 (R2015)

    Washer-disinfectors, Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc
    01/01/2013 - PDF sécurisé - Anglais - AAMI
    En savoir plus
    109,48 €

  • AAMI EQ 56:2013

    Recommended practice for a medical equipment management program
    01/01/2013 - PDF sécurisé - Anglais - AAMI
    En savoir plus
    168,36 €

  • AAMI/ISO 13408-1/A1:2013 (R2017)

    Aseptic processing of health care products - Part 1: General requirements
    01/01/2013 - PDF sécurisé - Anglais - AAMI
    En savoir plus
    58,88 €

  • AAMI/IEC 60601-1-8:2013

    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
    01/01/2013 - PDF sécurisé - Anglais - AAMI
    En savoir plus
    707,48 €

  • AAMI/IEC 80601-2-30/A1:2013 (R2017)

    Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated type non-invasive sphygmomanometers and Amendment 1
    01/01/2013 - PDF sécurisé - Anglais - AAMI
    En savoir plus
    55,20 €

  • AAMI EC 53:2013

    ECG trunk cables and patient leadwires
    01/01/2013 - PDF sécurisé - Anglais - AAMI
    En savoir plus
    109,48 €

  • AAMI/ISO 11137-1 AMD 1:2013

    Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices - Amendment 1
    01/01/2013 - PDF sécurisé - Anglais - AAMI
    En savoir plus
    29,44 €

  • AAMI/ISO 13408-6/A1:2013

    Aseptic processing of health care products - Part 6: Isolator systems - Amendment 1
    01/01/2013 - PDF sécurisé - Anglais - AAMI
    En savoir plus
    58,88 €

  • AAMI ST 8:2013

    Hospital steam sterilizers
    01/01/2013 - PDF sécurisé - Anglais - AAMI
    En savoir plus
    168,36 €

  • AAMI/ISO 5841-3:2013

    Implants for surgery - Cardiac pacemakers - Part 3: Low-profile connectors (IS-1) for implantable pacemakers
    01/01/2013 - PDF sécurisé - Anglais - AAMI
    En savoir plus
    109,48 €

  • AAMI ST 58:2013

    Chemical sterilization and high-level disinfection in health care facilities
    01/01/2013 - PDF sécurisé - Anglais - AAMI
    En savoir plus
    237,36 €

  • AAMI/ISO 11137-2:2013

    Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
    01/01/2013 - PDF sécurisé - Anglais - AAMI
    En savoir plus
    204,24 €

  • AAMI AT 6:2013

    Autologous transfusion devices
    01/01/2013 - PDF sécurisé - Anglais - AAMI
    En savoir plus
    109,48 €

  • AAMI/ISO 8637 AMD 1:2013 (R2015)

    Cardiovascular Implants and Extracorporeal Systems - Hemodialyzers, Hemodiafilters, Hemofilters and Hemoconcentrators
    01/01/2013 - PDF sécurisé - Anglais - AAMI
    En savoir plus
    58,88 €

  • AAMI NS 4:2013 (R2017)

    Transcutaneous electrical stimulators
    01/01/2013 - PDF sécurisé - Anglais - AAMI
    En savoir plus
    109,48 €

  • AAMI/ISO 27185:2012 (R2017)

    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 sécurisé - Anglais - AAMI
    En savoir plus
    204,24 €

  • AAMI/ISO 25539-3:2012 (R2015)

    Cardiovascular Implants - Endovascular Devices - Part 3: Vena Cava Filters
    01/01/2012 - PDF sécurisé - Anglais - AAMI
    En savoir plus
    223,56 €

  • AAMI PB 70:2012

    Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities
    01/01/2012 - PDF sécurisé - Anglais - AAMI
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    136,16 €

  • AAMI/ISO 11658:2012

    Cardiovascular implants and extracorporeal systems - Blood/tissue contact surface modifications for extracorporeal perfusion systems
    01/01/2012 - PDF sécurisé - Anglais - AAMI
    En savoir plus
    95,68 €

  • AAMI/IEC 60601-2-47:2012 (R2017)

    Medical electrical equipment - Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems.
    01/01/2012 - PDF sécurisé - Anglais - AAMI
    En savoir plus
    204,24 €

  • AAMI/ISO 10993-12:2012

    Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
    01/01/2012 - PDF sécurisé - Anglais - AAMI
    En savoir plus
    136,16 €

  • AAMI ES 60601-1/Amendment 1:2012

    Medical electrical equipment - Part 1: General requirements for basic safety and essential performance Amendment 1
    01/01/2012 - PDF sécurisé - Anglais - AAMI
    En savoir plus
    223,56 €

  • AAMI/ISO 13408-7:2012

    Aseptic processing of health care products - Part 7: Alternative processes for atypical medical devices and combination products
    01/01/2012 - PDF sécurisé - Anglais - AAMI
    En savoir plus
    136,16 €

  • AAMI ST 15883-1/A2:2012

    Washer-disinfectors - Part 1: General requirements, terms and definitions and tests, Amendment 2
    01/01/2012 - PDF sécurisé - Anglais - AAMI
    En savoir plus
    32,20 €

  • AAMI/IEC 60601-2-16:2012

    Medical electrical equipment - Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
    01/01/2012 - PDF sécurisé - Anglais - AAMI
    En savoir plus
    204,24 €

  • AAMI ST 15883-3:2012 (R2015)

    Washer-disinfectors, Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers
    01/01/2012 - PDF sécurisé - Anglais - AAMI
    En savoir plus
    109,48 €

  • AAMI/ISO 5840-3:2012

    Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by minimally invasive techniques
    01/01/2012 - PDF sécurisé - Anglais - AAMI
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    237,36 €

  • AAMI EC 57:2012

    Testing and reporting performance results of cardiac rhythm and ST segment measurement algorithms
    01/01/2012 - PDF sécurisé - Anglais - AAMI
    En savoir plus
    168,36 €

  • AAMI BF 7:2012

    Blood transfusion microfilters
    01/01/2012 - PDF sécurisé - Anglais - AAMI
    En savoir plus
    109,48 €

  • AAMI/ISO 14117:2012

    Active implantable medical devices - Electromagnetic compatibility - EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices
    01/01/2012 - PDF sécurisé - Anglais - AAMI
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    237,36 €

  • AAMI BF 64:2012

    Leukocyte reduction filters
    01/01/2012 - PDF sécurisé - Anglais - AAMI
    En savoir plus
    109,48 €

  • AAMI/ISO 25539-2:2012

    Cardiovascular implants - Endovascular devices - Part 2: Vascular stents
    01/01/2012 - PDF sécurisé - Anglais - AAMI
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    237,36 €

  • AAMI/ISO 13408-3:2012 (R2015)

    Aseptic processing of health care products - Part 3: Lyophilization
    01/01/2012 - PDF sécurisé - Anglais - AAMI
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    109,48 €

  • AAMI/ISO 13408-5:2012 (R2015)

    Aseptic processing of health care products - Part 5: Sterilization in place
    01/01/2012 - PDF sécurisé - Anglais - AAMI
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    109,48 €

  • AAMI/ISO 11140-4:2012 (R2015)

    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
    01/01/2012 - PDF sécurisé - Anglais - AAMI
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    168,36 €

  • AAMI/ISO 11140-3:2012 (R2015)

    Sterilization Of Health Care Products - Chemical Indicators - Part 3: Class 2 Indicator Systems For Use In The Bowie And Dick-Type Steam Penetration Test
    01/01/2012 - PDF sécurisé - Anglais - AAMI
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    168,36 €

  • AAMI/ISO 11140-5:2012 (R2015)

    Sterilization of Health Care Products - Chemical Indicators - Part 5: Class 2 Indicators for Bowie and Dick Air Removal Test Sheets and Packs
    01/01/2012 - PDF sécurisé - Anglais - AAMI
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    136,16 €

  • AAMI/ISO 13022:2012

    Medical products containing viable human cells -- Application of risk management and requirements for processing practices
    01/01/2012 - PDF sécurisé - Anglais - AAMI
    En savoir plus
    223,56 €

  • AAMI TIR29:2012/(R)2017

    Guide for process characterization and control in radiation sterilization of medical devices
    01/01/2012 - PDF - Anglais - AAMI
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    221,00 €

  • AAMI TIR30:2011(R2016)

    A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices
    08/10/2011 - PDF - Anglais - AAMI
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    183,08 €

  • AAMI ST 67:2011 (R2017)

    Sterilization of health care products - Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled 'sterile'
    01/01/2011 - PDF sécurisé - Anglais - AAMI
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    109,48 €

  • AAMI/IEC 60601-2-27:2011 (R2017)

    Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment
    01/01/2011 - PDF sécurisé - Anglais - AAMI
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    204,24 €

  • AAMI/ISO 14160:2011 (R2016)

    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
    01/01/2011 - PDF sécurisé - Anglais - AAMI
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    191,36 €

  • AAMI/IEC 60601-2-25:2011 (R2017)

    Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs
    01/01/2011 - PDF sécurisé - Anglais - AAMI
    En savoir plus
    285,20 €

  • AAMI ST 72:2011 (R2016)

    Bacterial endotoxin - Test methods, routine monitoring and alternatives to batch testing
    01/01/2011 - PDF sécurisé - Anglais - AAMI
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    204,24 €

  • AAMI/IEC 80601-2-35:2011

    Medical electrical equipment - Part 2-35: Particular requirements for basic safety and essential performance of blankets, pads and mattresses intended for heating in medical use, 2nd edition
    01/01/2011 - PDF sécurisé - Anglais - AAMI
    En savoir plus
    95,68 €

  • AAMI TIR42:2010

    Evaluation of particulates associated with vascular medical devices
    13/12/2010 - PDF - Anglais - AAMI
    En savoir plus
    221,00 €

  • AAMI TIR12:2010

    Designing, testing and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers
    07/09/2010 - PDF - Anglais - AAMI
    En savoir plus
    241,90 €

  • AAMI TIR12:2010 Redline

    Designing, testing and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers
    07/09/2010 - PDF - Anglais - AAMI
    En savoir plus
    218,04 €

  • AAMI/ISO 14708-5:2010 (R2015)

    Implants for surgery - Active implantable medical devices - Part 5: Circulatory support devices
    01/01/2010 - PDF sécurisé - Anglais - AAMI
    En savoir plus
    192,28 €

  • AAMI/ISO 10993-10:2010 (R2014)

    Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
    01/01/2010 - PDF sécurisé - Anglais - AAMI
    En savoir plus
    192,28 €

  • ANSI/AAMI/ ISO 8638:2010/(R)2015

    Cardiovascular implants and extracorporeal systems - Extracorporeal blood circuit for hemodialyzers, hemodiafilters and hemofilters
    01/01/2010 - PDF sécurisé - Anglais - AAMI
    En savoir plus
    144,44 €

  • 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 sécurisé - Anglais - AAMI
    En savoir plus
    168,36 €

  • AAMI/IEC 60601-2-4:2010 (R2015)

    Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators
    01/01/2010 - PDF sécurisé - Anglais - AAMI
    En savoir plus
    204,24 €

  • AAMI/ISO 10993-13:2010 (R2014)

    Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices
    01/01/2010 - PDF sécurisé - Anglais - AAMI
    En savoir plus
    95,68 €

  • AAMI/ISO 14155:2010

    Clinical investigation of medical devices for human subjects - Good clinical practice
    01/01/2010 - PDF sécurisé - Anglais - AAMI
    En savoir plus
    204,24 €

  • AAMI/ISO 20857:2010 (R2015)

    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 sécurisé - Anglais - AAMI
    En savoir plus
    204,24 €

  • AAMI/ISO 27186:2010 (R2011)

    Active implantable medical devices - Four-pole connector system for implantable cardiac rhythm management devices - Dimensional and test requirements
    01/01/2010 - PDF sécurisé - Anglais - AAMI
    En savoir plus
    237,36 €

  • AAMI/ISO 18472:2010 (R2015)

    Sterilization of Health Care Products - Biological and Chemical Indicators - Test Equipment
    01/01/2010 - PDF sécurisé - Anglais - AAMI
    En savoir plus
    191,36 €

  • AAMI/ISO 80369-1:2010

    Small bore connectors for liquids and gases in healthcare applications - Part 1: General requirements
    01/01/2010 - PDF sécurisé - Anglais - AAMI
    En savoir plus
    109,48 €

  • AAMI EC 12:2010 (R2015)

    Disposable ECG electrodes
    01/01/2010 - PDF sécurisé - Anglais - AAMI
    En savoir plus
    136,16 €

  • AAMI TIR39:2009/(R)2017

    Guidance on selecting a microbial challenge and inoculation sites for sterilization validation of medical devices
    23/11/2009 - PDF - Anglais - AAMI
    En savoir plus
    127,00 €

  • AAMI HE75:2009/(R)2018 (R2018)

    Human factors engineering - Design of medical devices
    21/10/2009 - PDF - Anglais - AAMI
    En savoir plus
    415,00 €

  • AAMI/IEC 60601-2-19:2009 (R2014)

    Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators
    01/01/2009 - PDF sécurisé - Anglais - AAMI
    En savoir plus
    168,36 €

  • AAMI/IEC 60601-2-20:2009 (R2014)

    Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators
    01/01/2009 - PDF sécurisé - Anglais - AAMI
    En savoir plus
    168,36 €

  • AAMI/IEC 60601-2-50:2009 (R2014)

    Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment
    01/01/2009 - PDF sécurisé - Anglais - AAMI
    En savoir plus
    136,16 €

  • AAMI/ISO 10993-5:2009 (R2014)

    Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
    01/01/2009 - PDF sécurisé - Anglais - AAMI
    En savoir plus
    136,16 €

  • AAMI/IEC 80601-2-30:2009

    Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
    01/01/2009 - PDF sécurisé - Anglais - AAMI
    En savoir plus
    204,24 €

  • AAMI/ISO 10993-1:2009 (R2013)

    Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
    01/01/2009 - PDF sécurisé - Anglais - AAMI
    En savoir plus
    136,16 €

  • AAMI/ISO 11737-2:2009 (R2014)

    Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
    01/01/2009 - PDF sécurisé - Anglais - AAMI
    En savoir plus
    109,48 €

  • AAMI/IEC 80601-2-30/C1:2009

    Medical electrical equipment - Part 2-30: Particular requirements for basic safety and essential performance of automated type non-invasive sphygmomanometers
    01/01/2009 - PDF sécurisé - Anglais - AAMI
    En savoir plus
    204,24 €

  • AAMI/ISO 14161:2009 (R2014)

    Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of results
    01/01/2009 - PDF sécurisé - Anglais - AAMI
    En savoir plus
    204,24 €

  • AAMI ES 60601-1 C 1 and A2:2009 (R2012)

    Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    01/01/2009 - PDF sécurisé - Anglais - AAMI
    En savoir plus
    895,16 €

  • AAMI ST 15883-1:2009 (R2014)

    Washer-disinfectors, Part 1: General requirements, terms and definitions and tests
    01/01/2009 - PDF sécurisé - Anglais - AAMI
    En savoir plus
    204,24 €

  • AAMI/ISO 14937:2009 (R2013)

    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 sécurisé - Anglais - AAMI
    En savoir plus
    175,72 €

  • AAMI/IEC 60601-2-21:2009 (R2014)

    Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers
    01/01/2009 - PDF sécurisé - Anglais - AAMI
    En savoir plus
    168,36 €

  • AAMI TIR31:2008

    Process Challenge Devices/Test Packs for Use in Health Care Facilities
    01/06/2008 - PDF - Anglais - AAMI
    En savoir plus
    194,00 €

  • AAMI RD 47:2008 (R2013)

    Reprocessing of hemodialyzers
    01/01/2008 - PDF sécurisé - Anglais - AAMI
    En savoir plus
    204,24 €

  • AAMI/ISO 13408-1:2008 (R2011)

    Aseptic processing of health care products - Part 1: General requirements
    01/01/2008 - PDF sécurisé - Anglais - AAMI
    En savoir plus
    204,24 €

  • AAMI/ISO 10993-7:2008 (R2012)

    Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
    01/01/2008 - PDF sécurisé - Anglais - AAMI
    En savoir plus
    214,36 €

  • AAMI ST 65:2008 (R2013)

    Processing of reusable surgical textiles for use in health care facilities
    01/01/2008 - PDF sécurisé - Anglais - AAMI
    En savoir plus
    204,24 €

  • AAMI/ISO 15882:2008 (R2013)

    Sterilization of health care products - Chemical indicators - Guidance for selection, use and interpretation of results
    01/01/2008 - PDF sécurisé - Anglais - AAMI
    En savoir plus
    168,36 €

  • AAMI/ISO 14708-4:2008 (R2011)

    Implants for surgery - Active implantable medical devices - Part 4: Implantable infusion pumps
    01/01/2008 - PDF sécurisé - Anglais - AAMI
    En savoir plus
    191,36 €

  • AAMI TIR36:2007

    Validation of software for regulated processes
    17/03/2007 - PDF - Anglais - AAMI
    En savoir plus
    274,00 €

  • AAMI/ISO 14971:2007 (R2016)

    Medical devices - Risk management - Application of risk management to medical devices
    01/01/2007 - PDF sécurisé - Anglais - AAMI
    En savoir plus
    237,36 €

  • AAMI/ISO 22442-3:2007 (R2016)

    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
    01/01/2007 - PDF sécurisé - Anglais - AAMI
    En savoir plus
    136,16 €

  • AAMI/ISO 81060-1:2007 (R2013)

    Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated meaasurement type
    01/01/2007 - PDF sécurisé - Anglais - AAMI
    En savoir plus
    191,36 €

  • AAMI/ISO 11137-1:2006 (R2015)

    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 sécurisé - Anglais - AAMI
    En savoir plus
    180,32 €

  • AAMI BE 83:2006 (R2011)

    Biological evaluation of medical devices - Part 18: Chemical characterization of materials
    01/01/2006 - PDF sécurisé - Anglais - AAMI
    En savoir plus
    109,48 €

  • AAMI/ISO 10993-2:2006 (R2014)

    Biological evaluation of medical devices - Part 2: Animal welfare requirements
    01/01/2006 - PDF sécurisé - Anglais - AAMI
    En savoir plus
    109,48 €

  • AAMI/ISO 10993-11:2006 (R2014)

    Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
    01/01/2006 - PDF sécurisé - Anglais - AAMI
    En savoir plus
    136,16 €

  • AAMI/ISO 17665-1:2005 (R2013)

    Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
    01/01/2005 - PDF sécurisé - Anglais - AAMI
    En savoir plus
    191,36 €

  • AAMI/ISO 13408-6:2005 (R2013)

    Aseptic processing of health care products - Part 6: Isolator systems
    01/01/2005 - PDF sécurisé - Anglais - AAMI
    En savoir plus
    58,88 €

  • AAMI/ISO 13408-4:2005 (R2014)

    Aseptic processing of health care products - Part 4: Clean-in-place technologies
    01/01/2005 - PDF sécurisé - Anglais - AAMI
    En savoir plus
    109,48 €

  • AAMI ST 50:2004 (R2018)

    Dry heat (heated air) sterilizers
    01/01/2004 - PDF sécurisé - Anglais - AAMI
    En savoir plus
    136,16 €

  • AAMI ST 40:2004 (R2018)

    Table-top dry heat (heated air) sterilization and sterility assurance in health care facilities
    01/01/2004 - PDF sécurisé - Anglais - AAMI
    En savoir plus
    204,24 €

  • AAMI/ISO 10993-17:2002 (R2012)

    Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances
    01/01/2002 - PDF sécurisé - Anglais - AAMI
    En savoir plus
    136,16 €

  • AAMI/ISO 10993-4:2002 (R2013)

    Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood
    01/01/2002 - PDF sécurisé - Anglais - AAMI
    En savoir plus
    58,88 €

  • AAMI/ISO 10993-14:2001 (R2011)

    Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics
    01/01/2001 - PDF sécurisé - Anglais - AAMI
    En savoir plus
    95,68 €

  • AAMI/ISO 10993-15:2000 (R2011)

    Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys
    01/01/2000 - PDF sécurisé - Anglais - AAMI
    En savoir plus
    109,48 €

  • AAMI/ISO 10993-9:1999 (R2014)

    Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products
    01/01/1999 - PDF sécurisé - Anglais - AAMI
    En savoir plus
    109,48 €

  • AAMI ST 24:1999 (R2013)

    Automatic, general-purpose ethylene oxide sterilizers and ethylene oxide sterilant sources intended for use in health care facilities
    01/01/1999 - PDF sécurisé - Anglais - AAMI
    En savoir plus
    136,16 €

  • AAMI ID 54:1996 (R2012)

    Enteral feeding set adapters and connectors
    01/01/1996 - PDF sécurisé - Anglais - AAMI
    En savoir plus
    58,88 €

  • AAMI BP 22:1994 (R2017)

    Blood pressure transducers
    01/01/1994 - PDF sécurisé - Anglais - AAMI
    En savoir plus
    109,48 €

  • AAMI NS 28:1988 (R2015)

    Intracranial pressure monitoring devices
    01/01/1988 - PDF sécurisé - Anglais - AAMI
    En savoir plus
    109,48 €

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