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  • ANSI/AAMI/ISO 15675:2016

    Current The latest, up-to-date edition.

    CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - CARDIOPULMONARY BYPASS SYSTEMS - ARTERIAL BLOOD LINE FILTERS

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  18-11-2016

    Publisher:  Association for the Advancement of Medical Instrumentation

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    Table of Contents - (Show below) - (Hide below)

    Glossary of equivalent standards
    Committee representation
    Background of AAMI adoption of ISO 15675:2016
    Foreword
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Requirements
    5 Tests and measurements to determine
      compliance with this document
    6 Information supplied by the manufacturer
    7 Packaging
    Bibliography

    Abstract - (Show below) - (Hide below)

    Describes requirements for sterile, single-use, arterial blood line filters intended to filter and remove emboli, debris, blood clots and other potentially hazardous solid and gaseous material from the blood of humans during cardiopulmonary bypass surgery.

    General Product Information - (Show below) - (Hide below)

    Document Type Standard
    Publisher Association for the Advancement of Medical Instrumentation
    Status Current
    Supersedes

    Standards Referenced By This Book - (Show below) - (Hide below)

    15/30290736 DC : 0 BS EN ISO 10993-4 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 4: SELECTION OF TESTS FOR INTERACTIONS WITH BLOOD

    Standards Referencing This Book - (Show below) - (Hide below)

    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
    ISO 10993-4:2017 Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood
    ISO 11607-2:2006 Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes
    ISO 15223-2:2010 Medical devices — Symbols to be used with medical device labels, labelling, and information to be supplied — Part 2: Symbol development, selection and validation
    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
    ISO 8637:2010 Cardiovascular implants and extracorporeal systems Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
    ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
    AAMI AT6 : 2013 AUTOLOGOUS TRANSFUSION DEVICES
    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
    ISO/TS 23810:2012 Cardiovascular implants and artificial organs Checklist for preoperative extracorporeal circulation equipment setup
    ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization
    ISO 7199:2016 Cardiovascular implants and artificial organs Blood-gas exchangers (oxygenators)
    ISO 10993-11:2017 Biological evaluation of medical devices — Part 11: Tests for systemic toxicity
    ISO 10993-7:2008 Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals
    ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    ISO 11607-1:2006 Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
    ISO 594-2:1998 Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 2: Lock fittings
    ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
    ISO 17665-1:2006 Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
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