• UNI EN ISO 7376 : 2009-10

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

    ANAESTHETIC AND RESPIRATORY EQUIPMENT - LARYNGOSCOPES FOR TRACHEAL INTUBATION

    Available format(s): 

    Superseded date:  12-09-2022

    Language(s): 

    Published date:  30-09-2009

    Publisher:  Ente Nazionale Italiano di Unificazione (UNI)

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

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 General requirements
       4.1 Design
       4.2 Materials for laryngoscope blades and single-piece
           laryngoscopes
       4.3 Environmental requirements
       4.4 Internal electrical power source
    5 Performance requirements
       5.1 Illumination
       5.2 Blade strength and rigidity
       5.3 Blade and handle hook-on fittings
       5.4 Handle fittings
       5.5 Blade fittings
       5.6 Engagement
       5.7 Operating position
       5.8 Disengagement
    6 Lamp for conventional blade
       6.1 Lamp and lamp base contact
       6.2 Screw thread for lamps
    7 Lamps for fibre-illuminated laryngoscopes
    8 Sockets for conventional blades
       8.1 Dimensions and centre contact
       8.2 Internal screw threads
    9 Cleaning, disinfection and sterilization
    10 Marking and labelling
    11 Accompanying documents
    Annex A (normative) - Test method for lamp contact security
    Annex B (normative) - Test methods for strength, rigidity
             and illumination
    Annex C (informative) - Blade size markings
    Annex D (informative) - Laryngoscope blade designs
    Annex E (informative) - Rationale for inclusion of certain
             requirements
    Annex ZA (informative) - Relationship between this International
             Standard and the Essential Requirements of EU
             Directive 93/42/EEC
    Bibliography

    Abstract - (Show below) - (Hide below)

    Provides general requirements for laryngoscopes used for intubation, and specifies critical dimensions for the handle and lamp of hook-on type laryngoscopes. Also specifies the interchangeability of blades and handles.

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

    Development Note Supersedes UNI EN 1819. (08/2004)
    Document Type Standard
    Publisher Ente Nazionale Italiano di Unificazione (UNI)
    Status Superseded
    Superseded By
    Supersedes

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

    ISO/IEC TR 10000-1:1998 Information technology Framework and taxonomy of International Standardized Profiles Part 1: General principles and documentation framework
    IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
    ISO 5864:1993 ISO inch screw threads Allowances and tolerances
    ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
    ISO 7000:2014 Graphical symbols for use on equipment Registered symbols
    ISO 4135:2001 Anaesthetic and respiratory equipment Vocabulary
    EN 980:2008 Symbols for use in the labelling of medical devices
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