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  • AAMI TIR17:2017

    Compatibility of materials subject to sterilization
    5/1/2018 - PDF sécurisé - English - AAMI
    Learn More
    €211.41

  • AAMI Standards online

    AAMI Standards online
    1/1/2018 - CD-Rom - English - AAMI
    Learn More
    €1,700.85

  • ANSI/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
    €141.81

  • ANSI/AAMI/ISO 13408-2:2018

    Aseptic processing of health care products - Part 2: Sterilizing filtration
    1/1/2018 - PDF sécurisé - English - AAMI
    Learn More
    €107.01

  • AAMI TIR16:2017

    Microbiological aspects of ethylene oxide sterilization
    11/17/2017 - PDF sécurisé - English - AAMI
    Learn More
    €132.24

  • ANSI/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
    €180.96

  • ANSI/AAMI CI 86:2017

    Cochlear implant systems - Safety, performance and reliability
    1/1/2017 - PDF sécurisé - English - AAMI
    Learn More
    €224.46

  • ANSI/AAMI/ISO 25539-1:2017

    Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses
    1/1/2017 - PDF sécurisé - English - AAMI
    Learn More
    €224.46

  • ANSI/AAMI/ISO 10993-6:2017

    Biological evaluation of medical devices -- Part 6: Tests for local effects after implantation
    1/1/2017 - PDF sécurisé - English - AAMI
    Learn More
    €128.76

  • ANSI/AAMI/IEC 60601-2-2:2017

    Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
    1/1/2017 - PDF sécurisé - English - AAMI
    Learn More
    €224.46

  • ANSI/AAMI ST 90:2017

    Processing of health care products - Quality management systems for processing in health care facilities
    1/1/2017 - PDF sécurisé - English - AAMI
    Learn More
    €180.96

  • ANSI/AAMI ST 79:2017

    Comprehensive guide to steam sterilization and sterility assurance in health care facilities
    1/1/2017 - PDF sécurisé - English - AAMI
    Learn More
    €344.52

  • ANSI/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
    1/1/2017 - PDF sécurisé - English - AAMI
    Learn More
    €193.14

  • ANSI/AAMI/ISO 17664:2017

    Sterilization of health care products - Information to be provided by the device manufacturer for the processing of medical devices
    1/1/2017 - PDF sécurisé - English - AAMI
    Learn More
    €159.21

  • ANSI/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
    €103.53

  • ANSI/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
    €103.53

  • ANSI/AAMI/ISO 11138-1:2017

    Sterilization of health care products - Biological indicators - Part 1: General requirements
    1/1/2017 - PDF sécurisé - English - AAMI
    Learn More
    €180.96

  • ANSI/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
    €103.53

  • ANSI/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
    €103.53

  • ANSI/AAMI/ISO 11137-3:2017

    Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control
    1/1/2017 - PDF sécurisé - English - AAMI
    Learn More
    €159.21

  • AAMI TIR15:2016

    Physical aspects of ethylene oxide sterilization
    11/18/2016 - PDF sécurisé - English - AAMI
    Learn More
    €128.76

  • AAMI TIR57:2016

    Principles for Medical Device Security - Risk Management
    6/5/2016 - PDF sécurisé - English - AAMI
    Learn More
    €224.46

  • ANSI/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
    €193.14

  • ANSI/AAMI/IEC 62304 AMD 1:2016

    Medical device software - Software life cycle processes, Amendment 1
    1/1/2016 - PDF sécurisé - English - AAMI
    Learn More
    €180.96

  • ANSI/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
    1/1/2016 - PDF sécurisé - English - AAMI
    Learn More
    €103.53

  • ANSI/AAMI/ISO 13485:2016

    Medical devices - Quality management systems - Requirements for regulatory purposes
    1/1/2016 - PDF sécurisé - English - AAMI
    Learn More
    €193.14

  • ANSI/AAMI/ISO 80369-5:2016

    Small-bore connectors for liquids and gases in healthcare application - Part 5: Connectors for limb cuff inflation applications
    1/1/2016 - PDF sécurisé - English - AAMI
    Learn More
    €159.21

  • ANSI/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
    1/1/2016 - PDF sécurisé - English - AAMI
    Learn More
    €193.14

  • ANSI/AAMI/IEC 60601-1-12:2016

    Medical electrical equipment -Part 1-12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment
    1/1/2016 - PDF sécurisé - English - AAMI
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    €193.14

  • ANSI/AAMI/ISO 80369-3:2016

    Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications
    1/1/2016 - PDF sécurisé - English - AAMI
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    €193.14

  • ANSI/AAMI/ISO 18242:2016

    Cardiovascular implants and extracorporeal systems - Centrifugal blood pumps
    1/1/2016 - PDF sécurisé - English - AAMI
    Learn More
    €103.53

  • ANSI/AAMI/ISO 18241:2016

    Cardiovascular implants and extracorporeal systems - Cardiopulmonary bypass systems - Venous bubble traps
    1/1/2016 - PDF sécurisé - English - AAMI
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    €128.76

  • ANSI/AAMI/ISO 15674:2016

    Cardiovascular implants and artificial organs - Hardshell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags
    1/1/2016 - PDF sécurisé - English - AAMI
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    €90.48

  • ANSI/AAMI/ISO 15675:2016

    Cardiovascular implants and artificial organs - Cardiopulmonary bypass systems - Arterial blood line filters
    1/1/2016 - PDF sécurisé - English - AAMI
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    €90.48

  • ANSI/AAMI/ISO 15676:2016

    Cardiovascular implants and artificial organs - Requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO)
    1/1/2016 - PDF sécurisé - English - AAMI
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    €103.53

  • ANSI/AAMI/ISO 22442-2:2016

    Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling
    1/1/2016 - PDF sécurisé - English - AAMI
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    €103.53

  • ANSI/AAMI/ISO 22442-1:2016

    Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management
    1/1/2016 - PDF sécurisé - English - AAMI
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    €159.21

  • ANSI/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
    1/1/2016 - PDF sécurisé - English - AAMI
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    €103.53

  • ANSI/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
    1/1/2016 - PDF sécurisé - English - AAMI
    Learn More
    €103.53

  • ANSI/AAMI/ISO 7198:2016

    Cardiovascular implants and extracorporeal systems - Vascular Prostheses - Tubular vascular grafts and vascular patches
    1/1/2016 - PDF sécurisé - English - AAMI
    Learn More
    €193.14

  • ANSI/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)
    1/1/2016 - PDF sécurisé - English - AAMI
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    €103.53

  • ANSI/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
    1/1/2016 - PDF sécurisé - English - AAMI
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    €90.48

  • ANSI/AAMI ST 55:2016

    Table-top steam sterilizers
    1/1/2016 - PDF sécurisé - English - AAMI
    Learn More
    €159.21

  • ANSI/AAMI/ISO 7199:2016

    Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators)
    1/1/2016 - PDF sécurisé - English - AAMI
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    €103.53

  • ANSI/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
    1/1/2016 - PDF sécurisé - English - AAMI
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    €193.14

  • ANSI/AAMI/ISO 15223-1:2016

    Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
    1/1/2016 - PDF sécurisé - English - AAMI
    Learn More
    €159.21

  • ANSI/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
    1/1/2016 - PDF sécurisé - English - AAMI
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    €90.48

  • ANSI/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
    1/1/2016 - PDF sécurisé - English - AAMI
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    €103.53

  • Sterilization Standards Collection Part 3

    Sterilization Standards Collection Part 3
    10/1/2015 - Paper - English - AAMI
    Learn More
    €530.70

  • AAMI Standards - Dialysis (PDF Format)

    The 2015 collection consists of 11 AAMI Hemodialysis standards, six of which were published in 2014
    1/1/2015 - PDF sécurisé - English - AAMI
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    €470.67

  • ANSI/AAMI EQ 89:2015

    Guidance for the use of medical equipment maintenance strategies and procedures
    1/1/2015 - PDF sécurisé - English - AAMI
    Learn More
    €103.53

  • ANSI/AAMI/IEC 62366-1:2015

    Medical devices - Application of usability Engineering to medical devices
    1/1/2015 - PDF sécurisé - English - AAMI
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    €180.96

  • ANSI/AAMI/ISO 80369-20:2015

    Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods
    1/1/2015 - PDF sécurisé - English - AAMI
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    €180.96

  • ANSI/AAMI ST 91:2015

    Flexible and semi-rigid endoscope reprocessing in health care facilities
    1/1/2015 - PDF sécurisé - English - AAMI
    Learn More
    €193.14

  • ANSI/AAMI/ISO 11135:2015

    Sterilization of health care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
    1/1/2015 - PDF sécurisé - English - AAMI
    Learn More
    €224.46

  • ANSI/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
    1/1/2015 - PDF sécurisé - English - AAMI
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    €269.70

  • ANSI/AAMI/ISO 5840-2:2015

    Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes
    1/1/2015 - PDF sécurisé - English - AAMI
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    €193.14

  • ANSI/AAMI/ISO 12417-1:2015

    Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 1: General requirements
    1/1/2015 - PDF sécurisé - English - AAMI
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    €193.14

  • ANSI/AAMI/ISO 5840-1:2015

    Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements
    1/1/2015 - PDF sécurisé - English - AAMI
    Learn More
    €193.14

  • ANSI/AAMI/ISO 23747:2015

    Anaesthetic and respiratory equipment - Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans
    1/1/2015 - PDF sécurisé - English - AAMI
    Learn More
    €120.06

  • ANSI/AAMI/ISO 5367:2015

    Anaesthetic and respiratory equipment - Breathing sets and connectors
    1/1/2015 - PDF sécurisé - English - AAMI
    Learn More
    €180.96

  • ANSI/AAMI/ISO 26782:2015

    Anaesthetic and respiratory equipment - Spirometers intended for the measurement of time forced expired volumes in humans
    1/1/2015 - PDF sécurisé - English - AAMI
    Learn More
    €159.21

  • ANSI/AAMI/ISO 8836:2015

    Suction catheters for use in the respiratory tract
    1/1/2015 - PDF sécurisé - English - AAMI
    Learn More
    €159.21

  • AAMI TIR34:2014

    Water for the reprocessing of medical devices
    4/8/2014 - PDF sécurisé - English - AAMI
    Learn More
    €193.14

  • AAMI TIR52:2014/(R)2017

    Environmental monitoring for terminally sterilized healthcare products
    3/10/2014 - PDF sécurisé - English - AAMI
    Learn More
    €103.53

  • ANSI/AAMI ST 15883-1/A1:2014

    Washer-disinfectors - Part 1: General requirements, terms and definitions and tests - Amendment 1
    1/1/2014 - PDF sécurisé - English - AAMI
    Learn More
    €193.14

  • ANSI/AAMI/ISO 5841-2:2014

    Implants for surgery - Cardiac pacemakers - Part 2: Reporting of clinical performance of populations of pulse generators or leads
    1/1/2014 - PDF sécurisé - English - AAMI
    Learn More
    €128.76

  • ANSI/AAMI 13958:2014

    Concentrates for haemodialysis and related therapies
    1/1/2014 - PDF sécurisé - English - AAMI
    Learn More
    €128.76

  • ANSI/AAMI 11663:2014

    Quality of dialysis fluid for haemodialysis and related therapies
    1/1/2014 - PDF sécurisé - English - AAMI
    Learn More
    €103.53

  • ANSI/AAMI 13959:2014

    Water for haemodialysis and related therapies
    1/1/2014 - PDF sécurisé - English - AAMI
    Learn More
    €103.53

  • ANSI/AAMI 26722:2014

    Water treatment equipment for haemodialysis applications and related therapies
    1/1/2014 - PDF sécurisé - English - AAMI
    Learn More
    €159.21

  • ANSI/AAMI 23500:2014

    Guidance for the preparation and quality management of fluids for haemodialysis and related therapies
    1/1/2014 - PDF sécurisé - English - AAMI
    Learn More
    €224.46

  • ANSI/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
    1/1/2014 - PDF sécurisé - English - AAMI
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    €55.68

  • ANSI/AAMI/ISO 10993-3:2014

    Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
    1/1/2014 - PDF sécurisé - English - AAMI
    Learn More
    €103.53

  • ANSI/AAMI/ISO 11140-1:2014

    Sterilization of health care products - Chemical indicators - Part 1: General requirements
    1/1/2014 - PDF sécurisé - English - AAMI
    Learn More
    €128.76

  • ANSI/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
    1/1/2014 - PDF sécurisé - English - AAMI
    Learn More
    €128.76

  • ANSI/AAMI/ISO 14708-1:2014

    Implants for surgery - Active implantable medical devices - Part 1: General requirements for safety, marking and for information to be provided by the manufacturer
    1/1/2014 - PDF sécurisé - English - AAMI
    Learn More
    €193.14

  • ANSI/AAMI/ISO 11607-1/A1:2014

    Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging
    1/1/2014 - PDF sécurisé - English - AAMI
    Learn More
    €52.20

  • ANSI/AAMI/ISO 11607-2 AMD 1:2014

    Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
    1/1/2014 - PDF sécurisé - English - AAMI
    Learn More
    €55.68

  • ANSI/AAMI ST 15883-2:2013

    Washer-disinfectors, Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc
    1/1/2013 - PDF sécurisé - English - AAMI
    Learn More
    €103.53

  • ANSI/AAMI EQ 56:2013

    Recommended practice for a medical equipment management program
    1/1/2013 - PDF sécurisé - English - AAMI
    Learn More
    €159.21

  • ANSI/AAMI ST 77:2013

    Containment devices for reusable medical device sterilization
    1/1/2013 - PDF sécurisé - English - AAMI
    Learn More
    €128.76

  • ANSI/AAMI/ISO 13408-1/A1:2013

    Aseptic processing of health care products - Part 1: General requirements
    1/1/2013 - PDF sécurisé - English - AAMI
    Learn More
    €55.68

  • ANSI/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
    1/1/2013 - PDF sécurisé - English - AAMI
    Learn More
    €669.03

  • ANSI/AAMI/IEC 80601-2-30/A1:2013

    Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated type non-invasive sphygmomanometers and Amendment 1
    1/1/2013 - PDF sécurisé - English - AAMI
    Learn More
    €52.20

  • ANSI/AAMI EC 53:2013

    ECG trunk cables and patient leadwires
    1/1/2013 - PDF sécurisé - English - AAMI
    Learn More
    €103.53

  • ANSI/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
    1/1/2013 - PDF sécurisé - English - AAMI
    Learn More
    €27.84

  • ANSI/AAMI/ISO 13408-6/A1:2013

    Aseptic processing of health care products - Part 6: Isolator systems - Amendment 1
    1/1/2013 - PDF sécurisé - English - AAMI
    Learn More
    €55.68

  • ANSI/AAMI ST 8:2013

    Hospital steam sterilizers
    1/1/2013 - PDF sécurisé - English - AAMI
    Learn More
    €159.21

  • ANSI/AAMI/ISO 5841-3:2013

    Implants for surgery - Cardiac pacemakers - Part 3: Low-profile connectors (IS-1) for implantable pacemakers
    1/1/2013 - PDF sécurisé - English - AAMI
    Learn More
    €103.53

  • ANSI/AAMI ST 58:2013

    Chemical sterilization and high-level disinfection in health care facilities
    1/1/2013 - PDF sécurisé - English - AAMI
    Learn More
    €224.46

  • ANSI/AAMI/ISO 11137-2:2013

    Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
    1/1/2013 - PDF sécurisé - English - AAMI
    Learn More
    €193.14

  • ANSI/AAMI AT 6:2013

    Autologous transfusion devices
    1/1/2013 - PDF sécurisé - English - AAMI
    Learn More
    €103.53

  • ANSI/AAMI/ISO 8637 AMD 1:2013

    Cardiovascular Implants and Extracorporeal Systems - Hemodialyzers, Hemodiafilters, Hemofilters and Hemoconcentrators
    1/1/2013 - PDF sécurisé - English - AAMI
    Learn More
    €55.68

  • ANSI/AAMI NS 4:2013

    Transcutaneous electrical nerve stimulators
    1/1/2013 - PDF sécurisé - English - AAMI
    Learn More
    €103.53

  • ANSI/AAMI/ISO 27185:2012

    Cardiac rhythm management devices - Symbols to be used with cardiac rhythm management device labels, and information to be supplied - General requirements
    1/1/2012 - PDF sécurisé - English - AAMI
    Learn More
    €193.14

  • ANSI/AAMI/ISO 25539-3:2012

    Cardiovascular Implants - Endovascular Devices - Part 3: Vena Cava Filters
    1/1/2012 - PDF sécurisé - English - AAMI
    Learn More
    €211.41

  • ANSI/AAMI PB 70:2012

    Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities
    1/1/2012 - PDF sécurisé - English - AAMI
    Learn More
    €128.76

  • ANSI/AAMI/ISO 11658:2012

    Cardiovascular implants and extracorporeal systems - Blood/tissue contact surface modifications for extracorporeal perfusion systems
    1/1/2012 - PDF sécurisé - English - AAMI
    Learn More
    €90.48

  • ANSI/AAMI/IEC 60601-2-47:2012

    Medical electrical equipment - Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems.
    1/1/2012 - PDF sécurisé - English - AAMI
    Learn More
    €193.14

  • ANSI/AAMI/ISO 10993-12:2012

    Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
    1/1/2012 - PDF sécurisé - English - AAMI
    Learn More
    €128.76

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

    Medical electrical equipment - Part 1: General requirements for basic safety and essential performance Amendment 1
    1/1/2012 - PDF sécurisé - English - AAMI
    Learn More
    €211.41

  • ANSI/AAMI/ISO 13408-7:2012

    Aseptic processing of health care products - Part 7: Alternative processes for atypical medical devices and combination products
    1/1/2012 - PDF sécurisé - English - AAMI
    Learn More
    €128.76

  • ANSI/AAMI ST 15883-1/A2:2012

    Washer-disinfectors - Part 1: General requirements, terms and definitions and tests, Amendment 2
    1/1/2012 - PDF sécurisé - English - AAMI
    Learn More
    €30.45

  • ANSI/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
    1/1/2012 - PDF sécurisé - English - AAMI
    Learn More
    €193.14

  • ANSI/AAMI ST 15883-3:2012

    Washer-disinfectors, Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers
    1/1/2012 - PDF sécurisé - English - AAMI
    Learn More
    €103.53

  • ANSI/AAMI/ISO 5840-3:2012

    Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by minimally invasive techniques
    1/1/2012 - PDF sécurisé - English - AAMI
    Learn More
    €224.46

  • ANSI/AAMI EC 57:2012

    Testing and reporting performance results of cardiac rhythm and ST segment measurement algorithms
    1/1/2012 - PDF sécurisé - English - AAMI
    Learn More
    €159.21

  • ANSI/AAMI BF 7:2012

    Blood transfusion microfilters
    1/1/2012 - PDF sécurisé - English - AAMI
    Learn More
    €103.53

  • ANSI/AAMI/ISO 14117:2012

    Active implantable medical devices - Electromagnetic compatibility - EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices
    1/1/2012 - PDF sécurisé - English - AAMI
    Learn More
    €224.46

  • ANSI/AAMI BF 64:2012

    Leukocyte reduction filters
    1/1/2012 - PDF sécurisé - English - AAMI
    Learn More
    €103.53

  • ANSI/AAMI/ISO 25539-2:2012

    Cardiovascular implants - Endovascular devices - Part 2: Vascular stents
    1/1/2012 - PDF sécurisé - English - AAMI
    Learn More
    €224.46

  • ANSI/AAMI/ISO 13408-3:2012

    Aseptic processing of health care products - Part 3: Lyophilization
    1/1/2012 - PDF sécurisé - English - AAMI
    Learn More
    €103.53

  • ANSI/AAMI/ISO 13408-5:2012

    Aseptic processing of health care products - Part 5: Sterilization in place
    1/1/2012 - PDF sécurisé - English - AAMI
    Learn More
    €103.53

  • AAMI TIR29:2012/(R)2017

    Guide for process characterization and control in radiation sterilization of medical devices
    1/1/2012 - PDF sécurisé - English - AAMI
    Learn More
    €180.96

  • ANSI/AAMI/ISO 11140-4:2012

    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
    1/1/2012 - PDF sécurisé - English - AAMI
    Learn More
    €159.21

  • ANSI/AAMI/ISO 11140-3:2012

    Sterilization Of Health Care Products - Chemical Indicators - Part 3: Class 2 Indicator Systems For Use In The Bowie And Dick-Type Steam Penetration Test
    1/1/2012 - PDF sécurisé - English - AAMI
    Learn More
    €159.21

  • ANSI/AAMI/ISO 11140-5:2012

    Sterilization of Health Care Products - Chemical Indicators - Part 5: Class 2 Indicators for Bowie and Dick Air Removal Test Sheets and Packs
    1/1/2012 - PDF sécurisé - English - AAMI
    Learn More
    €128.76

  • ANSI/AAMI/ISO 13022:2012

    Medical products containing viable human cells -- Application of risk management and requirements for processing practices
    1/1/2012 - PDF sécurisé - English - AAMI
    Learn More
    €211.41

  • AAMI TIR28:2016

    Product adoption and process equivalence for ethylene oxide sterilization
    1/1/2012 - PDF sécurisé - English - AAMI
    Learn More
    €103.53

  • AAMI TIR30:2011(R2016)

    A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices
    10/8/2011 - PDF sécurisé - English - AAMI
    Learn More
    €186.18

  • ANSI/AAMI ST 67:2011

    Sterilization of health care products - Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled 'sterile'
    1/1/2011 - PDF sécurisé - English - AAMI
    Learn More
    €103.53

  • ANSI/AAMI/IEC 60601-2-27:2011

    Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment
    1/1/2011 - PDF sécurisé - English - AAMI
    Learn More
    €193.14

  • ANSI/AAMI/ISO 14160:2011

    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
    1/1/2011 - PDF sécurisé - English - AAMI
    Learn More
    €180.96

  • ANSI/AAMI/IEC 60601-2-25:2011

    Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs
    1/1/2011 - PDF sécurisé - English - AAMI
    Learn More
    €269.70

  • ANSI/AAMI ST 72:2011

    Bacterial endotoxin - Test methods, routine monitoring and alternatives to batch testing
    1/1/2011 - PDF sécurisé - English - AAMI
    Learn More
    €193.14

  • ANSI/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
    1/1/2011 - PDF sécurisé - English - AAMI
    Learn More
    €90.48

  • AAMI TIR42:2010

    Evaluation of particulates associated with vascular medical devices
    12/13/2010 - PDF sécurisé - English - AAMI
    Learn More
    €180.96

  • AAMI TIR12:2010

    Designing, testing and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers
    9/7/2010 - PDF sécurisé - English - AAMI
    Learn More
    €199.23

  • ANSI/AAMI/ISO 14708-5:2010

    Implants for surgery - Active implantable medical devices - Part 5: Circulatory support devices
    1/1/2010 - PDF sécurisé - English - AAMI
    Learn More
    €181.83

  • ANSI/AAMI/ISO 10993-10:2010

    Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
    1/1/2010 - PDF sécurisé - English - AAMI
    Learn More
    €181.83

  • ANSI/AAMI/ISO 8638:2010

    Cardiovascular implants and extracorporeal systems - Extracorporeal blood circuit for hemodialyzers, hemodiafilters and hemofilters
    1/1/2010 - PDF sécurisé - English - AAMI
    Learn More
    €128.76

  • ANSI/AAMI/IEC 80001-1:2010

    Application of risk management for IT Networks incorporating medical devices - Part 1: Roles, responsibilities and activities
    1/1/2010 - PDF sécurisé - English - AAMI
    Learn More
    €159.21

  • ANSI/AAMI/IEC 60601-2-4:2010

    Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators
    1/1/2010 - PDF sécurisé - English - AAMI
    Learn More
    €193.14

  • ANSI/AAMI/ISO 10993-13:2010

    Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices
    1/1/2010 - PDF sécurisé - English - AAMI
    Learn More
    €90.48

  • ANSI/AAMI/ISO 14155:2010

    Clinical investigation of medical devices for human subjects - Good clinical practice
    1/1/2010 - PDF sécurisé - English - AAMI
    Learn More
    €193.14

  • ANSI/AAMI/ISO 20857:2010

    Sterilization of health care products - Dry heat: Requirements for the development, validation and routine control of a sterilization process for medical devices
    1/1/2010 - PDF sécurisé - English - AAMI
    Learn More
    €193.14

  • ANSI/AAMI/ISO 27186:2010

    Active implantable medical devices - Four-pole connector system for implantable cardiac rhythm management devices - Dimensional and test requirements
    1/1/2010 - PDF sécurisé - English - AAMI
    Learn More
    €224.46

  • ANSI/AAMI/ISO 18472:2010

    Sterilization of Health Care Products - Biological and Chemical Indicators - Test Equipment
    1/1/2010 - PDF sécurisé - English - AAMI
    Learn More
    €180.96

  • ANSI/AAMI/ISO 80369-1:2010

    Small bore connectors for liquids and gases in healthcare applications - Part 1: General requirements
    1/1/2010 - PDF sécurisé - English - AAMI
    Learn More
    €103.53

  • ANSI/AAMI EC 12:2010

    Disposable ECG electrodes
    1/1/2010 - PDF sécurisé - English - AAMI
    Learn More
    €128.76

  • AAMI TIR39:2009/(R)2017

    Guidance on selecting a microbial challenge and inoculation sites for sterilization validation of medical devices
    11/23/2009 - PDF sécurisé - English - AAMI
    Learn More
    €103.53

  • ANSI/AAMI/IEC 60601-2-19:2009

    Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators
    1/1/2009 - PDF sécurisé - English - AAMI
    Learn More
    €159.21

  • ANSI/AAMI/IEC 60601-2-20:2009

    Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators
    1/1/2009 - PDF sécurisé - English - AAMI
    Learn More
    €159.21

  • ANSI/AAMI/IEC 60601-2-50:2009

    Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment
    1/1/2009 - PDF sécurisé - English - AAMI
    Learn More
    €128.76

  • ANSI/AAMI/ISO 10993-5:2009

    Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
    1/1/2009 - PDF sécurisé - English - AAMI
    Learn More
    €128.76

  • ANSI/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
    1/1/2009 - PDF sécurisé - English - AAMI
    Learn More
    €193.14

  • ANSI/AAMI/ISO 10993-1:2009

    Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
    1/1/2009 - PDF sécurisé - English - AAMI
    Learn More
    €128.76

  • ANSI/AAMI/ISO 11737-2:2009

    Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
    1/1/2009 - PDF sécurisé - English - AAMI
    Learn More
    €103.53

  • ANSI/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
    1/1/2009 - PDF sécurisé - English - AAMI
    Learn More
    €193.14

  • ANSI/AAMI/ISO 14161:2009

    Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of results
    1/1/2009 - PDF sécurisé - English - AAMI
    Learn More
    €193.14

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

    Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    1/1/2009 - PDF sécurisé - English - AAMI
    Learn More
    €846.51

  • ANSI/AAMI ST 15883-1:2009

    Washer-disinfectors, Part 1: General requirements, terms and definitions and tests
    1/1/2009 - PDF sécurisé - English - AAMI
    Learn More
    €193.14

  • ANSI/AAMI/ISO 14937:2009

    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
    1/1/2009 - PDF sécurisé - English - AAMI
    Learn More
    €166.17

  • ANSI/AAMI/IEC 60601-2-21:2009

    Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers
    1/1/2009 - PDF sécurisé - English - AAMI
    Learn More
    €159.21

  • ANSI/AAMI HE 75:2009

    Human factors engineering - Design of medical devices
    1/1/2009 - PDF sécurisé - English - AAMI
    Learn More
    €339.30

  • AAMI TIR31:2008

    Process challenge devices/test packs for use in health care facilities
    6/1/2008 - PDF sécurisé - English - AAMI
    Learn More
    €159.21

  • ANSI/AAMI RD 47:2008

    Reprocessing of hemodialyzers
    1/1/2008 - PDF sécurisé - English - AAMI
    Learn More
    €193.14

  • ANSI/AAMI/ISO 13408-1:2008

    Aseptic processing of health care products - Part 1: General requirements
    1/1/2008 - PDF sécurisé - English - AAMI
    Learn More
    €193.14

  • ANSI/AAMI/ISO 10993-7:2008

    Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
    1/1/2008 - PDF sécurisé - English - AAMI
    Learn More
    €202.71

  • ANSI/AAMI ST 65:2008

    Processing of reusable surgical textiles for use in health care facilities
    1/1/2008 - PDF sécurisé - English - AAMI
    Learn More
    €193.14

  • ANSI/AAMI/ISO 15882:2008

    Sterilization of health care products - Chemical indicators - Guidance for selection, use and interpretation of results
    1/1/2008 - PDF sécurisé - English - AAMI
    Learn More
    €159.21

  • ANSI/AAMI/ISO 14708-4:2008

    Implants for surgery - Active implantable medical devices - Part 4: Implantable infusion pumps
    1/1/2008 - PDF sécurisé - English - AAMI
    Learn More
    €180.96

  • AAMI TIR36:2007

    Validation of Software for Regulated Processes
    3/17/2007 - PDF sécurisé - English - AAMI
    Learn More
    €224.46

  • ANSI/AAMI/ISO 14971:2007

    Medical devices - Risk management - Application of risk management to medical devices
    1/1/2007 - PDF sécurisé - English - AAMI
    Learn More
    €224.46

  • ANSI/AAMI/ISO 22442-3:2007

    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
    1/1/2007 - PDF sécurisé - English - AAMI
    Learn More
    €128.76

  • ANSI/AAMI/ISO 81060-1:2007

    Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated meaasurement type
    1/1/2007 - PDF sécurisé - English - AAMI
    Learn More
    €180.96

  • ANSI/AAMI/ISO 11137-1:2006

    Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
    1/1/2006 - PDF sécurisé - English - AAMI
    Learn More
    €170.52

  • ANSI/AAMI BE 83:2006

    Biological evaluation of medical devices - Part 18: Chemical characterization of materials
    1/1/2006 - PDF sécurisé - English - AAMI
    Learn More
    €103.53

  • ANSI/AAMI/ISO 10993-2:2006

    Biological evaluation of medical devices - Part 2: Animal welfare requirements
    1/1/2006 - PDF sécurisé - English - AAMI
    Learn More
    €103.53

  • ANSI/AAMI/ISO 10993-11:2006

    Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
    1/1/2006 - PDF sécurisé - English - AAMI
    Learn More
    €128.76

  • ANSI/AAMI/ISO 17665-1:2005

    Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
    1/1/2005 - PDF sécurisé - English - AAMI
    Learn More
    €180.96

  • ANSI/AAMI/ISO 13408-6:2005

    Aseptic processing of health care products - Part 6: Isolator systems
    1/1/2005 - PDF sécurisé - English - AAMI
    Learn More
    €55.68

  • ANSI/AAMI/ISO 13408-4:2005

    Aseptic processing of health care products - Part 4: Clean-in-place technologies
    1/1/2005 - PDF sécurisé - English - AAMI
    Learn More
    €103.53

  • ANSI/AAMI ST 50:2004

    Dry heat (heated air) sterilizers
    1/1/2004 - PDF sécurisé - English - AAMI
    Learn More
    €128.76

  • ANSI/AAMI ST 40:2004

    Table-top dry heat (heated air) sterilization and sterility assurance in health care facilities
    1/1/2004 - PDF sécurisé - English - AAMI
    Learn More
    €193.14

  • ANSI/AAMI/ISO 10993-17:2002

    Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances
    1/1/2002 - PDF sécurisé - English - AAMI
    Learn More
    €128.76

  • ANSI/AAMI/ISO 10993-4:2002

    Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood
    1/1/2002 - PDF sécurisé - English - AAMI
    Learn More
    €55.68

  • ANSI/AAMI/ISO 10993-14:2001

    Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics
    1/1/2001 - PDF sécurisé - English - AAMI
    Learn More
    €90.48

  • ANSI/AAMI/ISO 10993-15:2000

    Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys
    1/1/2000 - PDF sécurisé - English - AAMI
    Learn More
    €103.53

  • ANSI/AAMI ST 24:1999

    Automatic, general-purpose ethylene oxide sterilizers and ethylene oxide sterilant sources intended for use in health care facilities
    1/1/1999 - PDF sécurisé - English - AAMI
    Learn More
    €128.76

  • ANSI/AAMI/ISO 10993-9:1999

    Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products
    1/1/1999 - PDF sécurisé - English - AAMI
    Learn More
    €103.53

  • ANSI/AAMI ID 54:1996

    Enteral feeding set adapters and connectors
    1/1/1996 - PDF sécurisé - English - AAMI
    Learn More
    €55.68

  • ANSI/AAMI BP 22:1994

    Blood pressure transducers
    1/1/1994 - PDF sécurisé - English - AAMI
    Learn More
    €103.53

  • ANSI/AAMI NS 28:1988

    Intracranial pressure monitoring devices
    1/1/1988 - PDF sécurisé - English - AAMI
    Learn More
    €103.53

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