Skip to content
Please enter a keyword to search

  • ANSI/AAMI/ISO 15676:2016

    Current The latest, up-to-date edition.

    CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - REQUIREMENTS FOR SINGLE-USE TUBING PACKS FOR CARDIOPULMONARY BYPASS AND EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO)

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  18-11-2016

    Publisher:  Association for the Advancement of Medical Instrumentation

    Add To Cart

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

    Glossary of equivalent standards
    Committee representation
    Background of AAMI adoption of
    ISO 15676:2016
    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Requirements
    5 Tests and measurements
    6 Information supplied by the
      manufacturer
    7 Packaging
    Bibliography

    Abstract - (Show below) - (Hide below)

    Describes requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO).

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

    Committee ISO/TC 150
    Document Type Standard
    Publisher Association for the Advancement of Medical Instrumentation
    Status Current

    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 11607-2:2006 Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes
    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 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
    ASTM D 792 : 2013 : REDLINE Standard Test Methods for Density and Specific Gravity (Relative Density) of Plastics by Displacement
    ISO 9352:2012 Plastics — Determination of resistance to wear by abrasive wheels
    ISO 34-1:2015 Rubber, vulcanized or thermoplastic Determination of tear strength Part 1: Trouser, angle and crescent test pieces
    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 11137-2:2013 Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose
    ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
    ISO 11607-1:2006 Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
    ASTM D 638 : 2014 : REDLINE Standard Test Method for Tensile Properties of Plastics
    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
    ISO 527-1:2012 Plastics Determination of tensile properties Part 1: General principles
    ISO 868:2003 Plastics and ebonite — Determination of indentation hardness by means of a durometer (Shore hardness)
    View more information

    • Access your standards online with a subscription

      Features

      • Simple online access to standards, technical information and regulations
      • Critical updates of standards and customisable alerts and notifications
      • Multi - user online standards collection: secure, flexibile and cost effective