Skip to content
Please enter a keyword to search
  • Preview

    I.S. EN ISO 8536-13:2016

    Current The latest, up-to-date edition.

    INFUSION EQUIPMENT FOR MEDICAL USE - PART 13: GRADUATED FLOW REGULATORS FOR SINGLE USE WITH FLUID CONTACT (ISO 8536-13:2016)

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  01-01-2016

    Publisher:  National Standards Authority of Ireland

    For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
    Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

    Dates of withdrawal of national standards are available from NSAI.

    Add To Cart

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

    European foreword
    Foreword
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Design
    5 Materials
    6 Physical requirements
    7 Chemical requirements
    8 Biological requirements
    Annex A (normative) - Physical tests
    Bibliography
    Annex ZA (informative) - Relationship between
             this European Standard and the Essential
             Requirements of Directive 93/42/EEC [OJ L 169]
             aimed to be covered

    Abstract - (Show below) - (Hide below)

    Gives requirements for non-sterile, single-use graduated flow regulators used as subcomponents in sterilized infusion sets for single use to control the flow of intravenous infusion solutions with fluid contact under gravity feed conditions.

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

    Document Type Standard
    Publisher National Standards Authority of Ireland
    Status Current

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

    ISO 80000-4:2006 Quantities and units Part 4: Mechanics
    EN ISO 8536-4:2013/A1:2013 INFUSION EQUIPMENT FOR MEDICAL USE - PART 4: INFUSION SETS FOR SINGLE USE, GRAVITY FEED (ISO 8536-4:2010/AMD 1:2013)
    ISO 8536-4:2010 Infusion equipment for medical use Part 4: Infusion sets for single use, gravity feed
    ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
    EN ISO 10993-1:2009/AC:2010 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS (ISO 10993-1:2009/COR 1:2010)
    EN ISO 80000-4:2013 Quantities and units - Part 4: Mechanics (ISO 80000-4:2006)
    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