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    I.S. EN ISO 10555-4:2013

    View superseded by
    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    INTRAVASCULAR CATHETERS - STERILE AND SINGLE-USE CATHETERS - PART 4: BALLOON DILATATION CATHETERS (ISO 10555-4:2013)

    Available format(s):  Hardcopy, PDF

    Superseded date:  07-12-2023

    Language(s):  English

    Published date:  01-01-2013

    Publisher:  National Standards Authority of Ireland

    For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
    Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

    Dates of withdrawal of national standards are available from NSAI.

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

    Foreword
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Requirements
    Annex A (normative) - Test for balloon rated burst pressure
            (RBP)
    Annex B (normative) - Balloon fatigue test for freedom from
            leakage and damage on inflation
    Annex C (normative) - Test for balloon deflation time
    Annex D (normative) - Test for balloon diameter to inflation
            pressure
    Annex E (informative) - Guidance on the selection of balloon
            materials
    Bibliography
    Annex ZA (informative) - Relationship between this European
             Standard and the Essential Requirements of EU
             Directive 93/42/EEC amended by Directive 2007/47/EEC

    Abstract - (Show below) - (Hide below)

    Defines requirements for balloon dilatation catheters supplied in the sterile condition, and intended for single use.

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

    Document Type Standard
    Publisher National Standards Authority of Ireland
    Status Superseded
    Superseded By
    Supersedes

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

    ISO 11070:2014 Sterile single-use intravascular introducers, dilators and guidewires
    ISO 25539-2:2012 Cardiovascular implants Endovascular devices Part 2: Vascular stents
    ISO 14630:2012 Non-active surgical implants General requirements
    ISO/TS 12417:2011 Cardiovascular implants and extracorporeal systems Vascular device-drug combination products
    ISO 10555-1:2013 Intravascular catheters — Sterile and single-use catheters — Part 1: General requirements
    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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