Skip to content
Please enter a keyword to search
  • Preview

    I.S. EN 13544-3:2001

    View superseded by
    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
    View superseded by

    RESPIRATORY THERAPY EQUIPMENT - PART 3: AIR ENTRAINMENT DEVICES

    Available format(s):  Hardcopy, PDF

    Superseded date:  28-09-2009

    Language(s):  English

    Published date:  03-11-2001

    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)

    Foreword
    1 Scope
    2 Normative references
    3 Terms and definition
    4 Oxygen supply
    5 Connections
    6 Delivered oxygen concentration
    7 Marking and identification
    8 Information supplied by the manufacturer
    9 Usability
    10 Clinical evaluation
    Annex A (normative) - Method of test for delivered oxygen
                          concentration
    Annex B (informative) - Rationale
    Annex C (informative) - Colour coding
    Annex ZA (informative) - Relationship between this European
                             Standard and the Essential
                             Requirements of EU Directive
                             93/42/EEC
    Bibliography

    Abstract - (Show below) - (Hide below)

    Defines minimum performance and safety requirements for air entrainment devices used for delivery of a designated oxygen concentration to patients.

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

    Development Note 2001 Edition Re-Issued in September 2009 & incorporates AMD 1 2009. (10/2009)
    Document Type Standard
    Publisher National Standards Authority of Ireland
    Status Superseded
    Superseded By

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

    EN 738-1:1997/A1:2002 PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PRESSURE REGULATORS AND PRESSURE REGULATORS WITH FLOW METERING DEVICES
    EN 60601-1-6:2010/A1:2015 MEDICAL ELECTRICAL EQUIPMENT - PART 1-6: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: USABILITY (IEC 60601-1-6:2010/A1:2013)
    EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
    EN 62366 : 2008 AMD 1 2015 MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES (IEC 62366:2007/A1:2014)
    BS 381C(1988) : LATEST SPECIFICATION FOR COLOURS FOR IDENTIFICATION, CODING AND SPECIAL PURPOSES
    EN ISO 4135:2001 ANAESTHETIC AND RESPIRATORY EQUIPMENT - VOCABULARY
    EN 980:2008 Symbols for use in the labelling of medical devices
    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