• EN ISO 7376:2009

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 (ISO 7376:2009)

    Available format(s): 

    Superseded date:  01-10-2020

    Language(s): 

    Published date:  15-08-2009

    Publisher:  Comite Europeen de Normalisation

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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
    5 Performance requirements
    6 Lamp for conventional blade
    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 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)

    ISO 7376:2009 gives general requirements for laryngoscopes used for intubation, and specifies critical dimensions for the handle and lamp of hook-on type laryngoscopes. It also addresses the interchangeability of blades and handles.It is applicable only to instruments with an internal battery-operated power source for illuminating the larynx, since electrical safety requirements can be more stringent for instruments connected to mains or external power packs.It is not applicable to surgical instruments known by the same generic name, nor is it applicable to flexible laryngoscopes or laryngoscopes designed for surgery, laryngoscopes powered from mains electricity supply, laryngoscopes connected by light-transmitting cables to external light sources, or video laryngoscopes designed to work with an external video system.

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

    Development Note Supersedes EN 1819. (01/2004)
    Document Type Standard
    Publisher Comite Europeen de Normalisation
    Status Superseded
    Superseded By
    Supersedes

    Standards Referenced By This Book - (Show below) - (Hide below)

    12/30266576 DC : 0 BS EN 13718-2 - MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 2: OPERATIONAL AND TECHNICAL REQUIREMENTS OF AIR AMBULANCES
    EN 13718-2:2015 Medical vehicles and their equipment - Air ambulances - Part 2: Operational and technical requirements for air ambulances
    UNI EN 13976-2 : 2011 RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 2: SYSTEM REQUIREMENTS
    UNE-EN 13976-2:2011 Rescue systems - Transportation of incubators - Part 2: System requirements
    DIN EN 13718-2:2015-05 MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 2: OPERATIONAL AND TECHNICAL REQUIREMENTS FOR AIR AMBULANCES
    UNE-EN 13718-2:2015 Medical vehicles and their equipment - Air ambulances - Part 2: Operational and technical requirements for air ambulances
    PREN 13976-2 : DRAFT 2016 RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 2: SYSTEM REQUIREMENTS
    16/30333925 DC : 0 BS EN 13976-2 - RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 2: SYSTEM REQUIREMENTS
    I.S. EN 13976-2:2011 RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 2: SYSTEM REQUIREMENTS
    BS EN 13976-2:2011 Rescue systems. Transportation of incubators System requirements
    BS EN 13718-2:2015 Medical vehicles and their equipment. Air ambulances Operational and technical requirements for air ambulances
    I.S. EN 13718-2:2015 MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 2: OPERATIONAL AND TECHNICAL REQUIREMENTS FOR AIR AMBULANCES
    DIN EN 13976-2 E : 2011 RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 2: SYSTEM REQUIREMENTS
    I.S. EN 13718-2:2015+A1:2020 MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 2: OPERATIONAL AND TECHNICAL REQUIREMENTS FOR AIR AMBULANCES
    EN 13976-2:2011 Rescue systems - Transportation of incubators - Part 2: System requirements
    DIN EN 13976-2:2016-03 (Draft) RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 2: SYSTEM REQUIREMENTS
    DIN EN 13976-2:2011-08 RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 2: SYSTEM REQUIREMENTS

    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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