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  • DIN EN ISO 10555-4:2013-11

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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    Superseded date:  01-03-2024

    Language(s):  German, English

    Published date:  01-11-2013

    Publisher:  German Institute for Standardisation (Deutsches Institut für Normung)

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

    National foreword
    National Annex NA (informative) - Bibliography
    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
    Annex ZA (informative) - Relationship between this European
             Standard and the Essential Requirements of EU
             Directive 93/42/EEC amended by Directive 2007/47/EEC
    Bibliography

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

    Document Type Standard
    Publisher German Institute for Standardisation (Deutsches Institut für Normung)
    Status Superseded
    Superseded By
    Supersedes

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

    BWB TL 6515-0166 : 1ED 2007 SAFETY 4 CATHETER 0.90 X 25MM, 22G, BLUE
    BWB TL 6515-0170 : 1ED 2007 STYLET FOR SAFETY 4 CATHETER 16G, GREY
    DIN EN ISO 11070:2015-03 STERILE SINGLE-USE INTRAVASCULAR INTRODUCERS, DILATORS AND GUIDEWIRES (ISO 11070:2014)
    BWB TL 6515-0164 : 1ED 2007 SAFETY 4 CATHETER 1.70 X 50MM, 16G, GREY
    BWB TL 6515-0172 : 1ED 2007 STYLET FOR SAFETY 4 CATHETER 22G, BLUE
    BWB TL 6515-0175 : 2ED 2008 STYLET FOR SAFETY 4 CATHETER 20G, PINK
    DIN HDBK 227/2 : 5ED 2016 MEDIZINISCHE EINMALPRODUKTE - BAND 2: HAEMODIALYSE, DRAINAGEN UND KATHETER, HANDSCHUHE, KONDOME SOWIE INKONTINENZ- UND OSTOMIEHILFEN
    DIN EN ISO 25539-1:2015-07 (Draft) CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES (ISO 25539-1:2017)
    BWB TL 6515-0168 : 1ED 2007 SAFETY 4 CATHETER 1.10 X 33MM, 20G, PINK
    BWB TL 6515-0167 : 1ED 2007 SAFETY 4 CATHETER 1.50 X 45 MM, 17G, WHITE

    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
    DIN EN ISO 11070:2015-03 STERILE SINGLE-USE INTRAVASCULAR INTRODUCERS, DILATORS AND GUIDEWIRES (ISO 11070:2014)
    DIN EN ISO 25539-2:2013-05 Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2012)
    DIN EN ISO 14630:2013-03 Non-active surgical implants - General requirements (ISO 14630:2012)
    ISO/TS 12417:2011 Cardiovascular implants and extracorporeal systems Vascular device-drug combination products
    DIN EN 1707:1997-01 CONICAL FITTINGS WITH A 6% (LUER) TAPER FOR SYRINGES, NEEDLES AND CERTAIN OTHER MEDICAL EQUIPMENT - LOCK FITTINGS
    DIN EN 20594-1:1995-01 CONICAL FITTINGS WITH A 6 % (LUER) TAPER FOR SYRINGES, NEEDLES AND CERTAIN OTHER MEDICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS
    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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