• EN 1733 : 2002

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

    SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT

    Available format(s): 

    Superseded date:  01-06-2008

    Language(s): 

    Published date:  12-01-2013

    Publisher:  Comite Europeen de Normalisation

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

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Definitions
    4 Size designation and dimensions
    5 Materials
    6 Design
    7 Performance requirements
    8 Requirements for suction catheters supplied sterile
    9 Marking
    Annex A (normative) Guidance on design and materials
    Annex B (normative) Test method for security of
            construction
    Annex C (normative) Test method for residual vacuum
    Bibliography

    Abstract - (Show below) - (Hide below)

    Gives requirements for suction catheters made of plastics materials and intended for use in suction of the respiratory tract. However, specialized suction catheters, for e.g. those with more than one lumen, are excluded from the scope of this standard.

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

    Committee TC 215
    Document Type Standard
    Publisher Comite Europeen de Normalisation
    Status Superseded
    Superseded By

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

    ISO 8836:2014 Suction catheters for use in the respiratory tract
    EN 1282-1 : 1996 ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEOSTOMY TUBES - TUBES FOR USE IN ADULTS
    EN 1782:1998+A1:2009 Tracheal tubes and connectors
    EN 1282-2:2005+A1:2009 Tracheostomy tubes - Part 2: Paediatric tubes (ISO 5366-3:2001, modified)
    EN 868-1 : 1997 PACKAGING MATERIALS AND SYSTEMS FOR MEDICAL DEVICES WHICH ARE TO BE STERILIZED - GENERAL REQUIREMENTS AND TEST METHODS
    EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
    ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
    ISO/TR 11991:1995 Guidance on airway management during laser surgery of upper airway
    ISO 7000:2014 Graphical symbols for use on equipment Registered symbols
    ISO 4135:2001 Anaesthetic and respiratory equipment Vocabulary
    EN ISO 4135:2001 ANAESTHETIC AND RESPIRATORY EQUIPMENT - VOCABULARY
    EN 980:2008 Symbols for use in the labelling of medical devices
    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)
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