• I.S. EN 1819:1998

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

    LARYNGOSCOPES FOR TRACHEAL INTUBATION - PARTICULAR REQUIREMENTS

    Available format(s):  Hardcopy, PDF

    Superseded date:  22-04-2004

    Language(s):  English

    Published date:  01-01-1998

    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.

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

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Definitions
    4 General requirements
    5 Performance requirements
    6 Lamps for conventional blades
    7 Lamps for fibre-illuminated laryngoscopes
    8 Sockets for conventional blades
    9 Cleaning, disinfection and sterilization
    10 Marking and labelling
    11 Accompanying documents
    Annex A (normative) Test methods
    Annex B (normative) Conventional marking of laryngoscope
                            blades to indicate type and size
    Annex C (informative) Rationale
    Annex D (informative) Recommendations for design and materials
    Annex E (informative) Bibliography
    Annex ZA (informative) Clauses of this European Standard
                            addressing essential requirements
                            or other provisions of EU Directives

    Abstract - (Show below) - (Hide below)

    Defines general requirements for laryngoscopes and critical dimensions for the handle and lamp of hook-on type laryngoscopes.

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

    Document Type Standard
    Publisher National Standards Authority of Ireland
    Status Superseded
    Superseded By

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

    EN 556:1994 + A1:1998 STERILIZATION OF MEDICAL DEVICES - REQUIREMENTS FOR TERMINALLY-STERILIZED MEDICAL DEVICES TO BE LABELLED "STERILE"
    EN 550 : 1994 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF ETHYLENE OXIDE STERILIZATION
    EN 868-1 : 1997 PACKAGING MATERIALS AND SYSTEMS FOR MEDICAL DEVICES WHICH ARE TO BE STERILIZED - GENERAL REQUIREMENTS AND TEST METHODS
    ISO 5864:1993 ISO inch screw threads Allowances and tolerances
    EN 552:1994/A2:2000 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY IRRADIATION
    ISO 7376-3:1996 Laryngoscopic fittings Part 3: Fibre-illuminated re-usable rigid laryngoscopes
    ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
    EN ISO 4135:2001 ANAESTHETIC AND RESPIRATORY EQUIPMENT - VOCABULARY
    EN 980:2008 Symbols for use in the labelling of medical devices
    EN 554 : 1994 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY MOIST HEAT
    EN 30993-1 : 1994 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - GUIDANCE ON SELECTION OF TESTS
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