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  • BS EN 1282-2 : 2005

    Current The latest, up-to-date edition.
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    TRACHEOSTOMY TUBES - PART 2: PAEDIATRIC TUBES

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  01-01-2009

    Publisher:  British Standards Institution

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

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Size designation and dimensions
    5 Materials
    6 Design and finish
    7 Requirements for tracheostomy tubes supplied sterile
    8 Marking
    9 Adaptor
    Annex A (normative) - Test for security of attachment of
            permanently attached connector, if provided, and
            neck-plate to tracheostomy tube
    Annex B (normative) - Test method for determining the
            resting diameter of the cuff
    Annex C (informative) - Guidance on materials and design
    Annex ZA (informative) - Relationship between this European
             Standard and the Essential Requirements of EU
             Directive 93/42/EEC Medical devices
    Bibliography

    Abstract - (Show below) - (Hide below)

    Describes requirements for paediatric tracheostomy tubes made of plastics materials and/or rubber having inside diameters from 2,0 mm to 6,0 mm.

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

    Committee CH/121/5
    Development Note Supersedes 94/505405 DC. (08/2005)
    Document Type Standard
    Publisher British Standards Institution
    Status Current
    Supersedes

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

    BS 7143:1989 SPECIFICATION FOR CATHETER MOUNTS (FLEXIBLE ADAPTORS) FOR USE WITH MEDICAL BREATHING SYSTEMS

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

    EN 556-1:2001/AC:2006 STERILIZATION OF MEDICAL DEVICES - REQUIREMENTS FOR MEDICAL DEVICES TO BE DESIGNATED "STERILE" - PART 1: REQUIREMENTS FOR TERMINALLY STERILIZED MEDICAL DEVICES
    EN ISO 5356-1:2015 ANAESTHETIC AND RESPIRATORY EQUIPMENT - CONICAL CONNECTORS - PART 1: CONES AND SOCKETS (ISO 5356-1:2015)
    ISO 5356-1:2015 Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets
    EN 1041:2008+A1:2013 INFORMATION SUPPLIED BY THE MANUFACTURER OF MEDICAL DEVICES
    ISO 5366-1:2000 Anaesthetic and respiratory equipment Tracheostomy tubes Part 1: Tubes and connectors for use in adults
    EN ISO 5366-1:2009 ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEOSTOMY TUBES - PART 1: TUBES AND CONNECTORS FOR USE IN ADULTS
    ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
    ISO 11607:2003 Packaging for terminally sterilized medical devices
    ISO 5361:2016 Anaesthetic and respiratory equipment Tracheal tubes and connectors
    ISO/TR 11991:1995 Guidance on airway management during laser surgery of upper airway
    ISO 4135:2001 Anaesthetic and respiratory equipment Vocabulary
    EN 20594-1:1993/A1:1997 CONICAL FITTINGS WITH A 6% (LUER) TAPER FOR SYRINGES, NEEDLES AND CERTAIN OTHER MEDICAL EQUIPMENT - GENERAL REQUIREMENTS
    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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