• ANSI/AAMI/ISO 80369-3:2016

    Current The latest, up-to-date edition.

    SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 3: CONNECTORS FOR ENTERAL APPLICATIONS

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  03-08-2016

    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 on ANSI/AAMI adoption
    of ISO 80369-3:2016
    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 General requirements
    5 Dimensional requirements for
      ENTERAL SMALL-BORE CONNECTORS
    6 Performance requirements
    Annex A (informative) - Rationale and
            guidance
    Annex B (normative) - ENTERAL SMALL-BORE
           CONNECTORS
    Annex C (normative) - Reference CONNECTORS
    Annex D (informative) - Assessment of MEDICAL
            DEVICES and their attributes with CONNECTIONS
            within this APPLICATION
    Annex E (informative) - Summary of the usability
            requirements for SMALL-BORE CONNECTORS
            for ENTERAL applications
    Annex F (informative) - Summary of SMALL-BORE
            CONNECTOR criteria and requirements for
            ENTERAL APPLICATIONS
    Annex G (informative) - Summary of assessment
            of the design of the CONNECTORS for ENTERAL
            APPLICATIONS
    Annex H (informative) - Reference to the essential
            principles
    Annex I (informative) - Terminology - Alphabetized
            index of defined terms
    Bibliography

    Abstract - (Show below) - (Hide below)

    Describes the dimensions and requirements for the design and functional performance of SMALL-BORE CONNECTORS intended to be used for CONNECTIONS on ENTERAL MEDICAL DEVICES and ACCESSORIES.

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

    Committee ISO/TC 210
    Development Note NEW CHILD AMD 1 NOW IS ADDED
    Document Type Standard
    Product Note NEW CHILD AMD 1 NOW IS ADDED
    Publisher Association for the Advancement of Medical Instrumentation
    Status Current

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

    EN 1618 : 1997 CATHETERS OTHER THAN INTRAVASCULAR CATHETERS - TEST METHODS FOR COMMON PROPERTIES
    ISO 80369-20:2015 Small-bore connectors for liquids and gases in healthcare applications Part 20: Common test methods
    IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    ISO 5356-1:2015 Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets
    ISO 10241-2:2012 Terminological entries in standards — Part 2: Adoption of standardized terminological entries
    ISO 5356-2:2012 Anaesthetic and respiratory equipment — Conical connectors — Part 2: Screw-threaded weight-bearing connectors
    IEC 62366:2007+AMD1:2014 CSV Medical devices - Application of usability engineering to medical devices
    ISO 7886-1:2017 Sterile hypodermic syringes for single use — Part 1: Syringes for manual use
    CR 13825:2000 Luer connectors - A report to CEN chef from the CEN forum task group "Luer fittings"
    ISO 8185:2007 Respiratory tract humidifiers for medical use Particular requirements for respiratory humidification systems
    ISO 80369-6:2016 Small bore connectors for liquids and gases in healthcare applications — Part 6: Connectors for neuraxial applications
    ASTM D 790 : 2017 : REDLINE Standard Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials
    ISO 80369-1:2010 Small-bore connectors for liquids and gases in healthcare applications Part 1: General requirements
    ISO 80369-7:2016 Small-bore connectors for liquids and gases in healthcare applications Part 7: Connectors for intravascular or hypodermic applications
    EN 1615 : 2000 ENTERAL FEEDING CATHETERS AND ENTERAL GIVING SETS FOR SINGLE USE AND THEIR CONNECTORS - DESIGN AND TESTING
    ISO 10241-1:2011 Terminological entries in standards — Part 1: General requirements and examples of presentation
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    EN 13544-2:2002+A1:2009 Respiratory therapy equipment - Part 2: Tubing and connectors
    ASTM D 638 : 2014 : REDLINE Standard Test Method for Tensile Properties of Plastics
    • 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