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  • BS ISO 8600-1:2015

    Current The latest, up-to-date edition.

    Endoscopes. Medical endoscopes and endotherapy devices General requirements

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  31-10-2015

    Publisher:  British Standards Institution

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

    Foreword
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Requirements
    5 Testing
    6 Marking
    7 Instruction manual
    8 Packaging
    Annex A (informative) - Guidelines on the application of
            risk management to endoscopic system connector
    Bibliography

    Abstract - (Show below) - (Hide below)

    Provides definitions of terms and requirements for endoscopes and endotherapy devices used in the practice of medicine.

    Scope - (Show below) - (Hide below)

    This part of ISO8600 gives definitions of terms and requirements for endoscopes and endotherapy devices used in the practice of medicine.

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

    Committee CPW/172
    Development Note Supersedes 88/55910 DC. (07/2005) Supersedes 04/30105055 DC. (09/2005) Supersedes 12/30228200 DC. (04/2013)
    Document Type Standard
    Publisher British Standards Institution
    Status Current
    Supersedes

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

    ISO 8600-4:2014 Endoscopes — Medical endoscopes and endotherapy devices — Part 4: Determination of maximum width of insertion portion
    IEC 60601-2-18:2009 Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment
    ISO 8600-3:1997 Optics and optical instruments Medical endoscopes and endoscopic accessories Part 3: Determination of field of view and direction of view of endoscopes with optics
    ISO 8600-6:2005 Optics and photonics Medical endoscopes and endotherapy devices Part 6: Vocabulary
    ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    ISO 594-2:1998 Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 2: Lock fittings
    ISO 594-1:1986 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 1: General requirements
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