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  • DIN EN ISO 13958:2016-03

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    CONCENTRATES FOR HAEMODIALYSIS AND RELATED THERAPIES (ISO 13958:2014)

    Available format(s):  Hardcopy, PDF

    Superseded date:  26-01-2021

    Language(s):  German, English

    Published date:  01-01-2016

    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
    European foreword
    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Requirements
    5 Tests
    6 Labelling
    Annex A (informative) - Rationale for the development
            and provisions of this International Standard
    Annex ZA (informative) - Relationship between this
             European Standard and the Essential Requirements
             of EU Directive 93/42/EEC on medical devices
    Bibliography

    Abstract - (Show below) - (Hide below)

    This standard is included in DIN Handbook 227/2.

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

    Development Note Supersedes DIN EN 13867. (04/2016)
    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    Status Superseded
    Superseded By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)

    DIN EN ISO 11663 E : 2016 QUALITY OF DIALYSIS FLUID FOR HAEMODIALYSIS AND RELATED THERAPIES (ISO 11663:2014)
    DIN EN ISO 11663:2016-02 QUALITY OF DIALYSIS FLUID FOR HAEMODIALYSIS AND RELATED THERAPIES (ISO 11663:2014)
    DIN EN ISO 23500:2015-12 GUIDANCE FOR THE PREPARATION AND QUALITY MANAGEMENT OF FLUIDS FOR HAEMODIALYSIS AND RELATED THERAPIES (ISO 23500:2014)
    DIN HDBK 227/2 : 5ED 2016 MEDIZINISCHE EINMALPRODUKTE - BAND 2: HAEMODIALYSE, DRAINAGEN UND KATHETER, HANDSCHUHE, KONDOME SOWIE INKONTINENZ- UND OSTOMIEHILFEN
    DIN EN ISO 23500 E : 2015 GUIDANCE FOR THE PREPARATION AND QUALITY MANAGEMENT OF FLUIDS FOR HAEMODIALYSIS AND RELATED THERAPIES (ISO 23500:2014)

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

    DIN EN ISO 13959:2016-03 WATER FOR HAEMODIALYSIS AND RELATED THERAPIES (ISO 13959:2014)
    ISO 11663:2014 Quality of dialysis fluid for haemodialysis and related therapies
    IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    EN ISO 13959:2015 Water for haemodialysis and related therapies (ISO 13959:2014)
    DIN EN ISO 14971:2013-04 MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES (ISO 14971:2007)
    DIN EN ISO 11663:2016-02 QUALITY OF DIALYSIS FLUID FOR HAEMODIALYSIS AND RELATED THERAPIES (ISO 11663:2014)
    IEC 60601-2-16 : 4.0 MEDICAL ELECTRICAL EQUIPMENT - PART 2-16: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HAEMODIALYSIS, HAEMODIAFILTRATION AND HAEMOFILTRATION EQUIPMENT
    ISO 23500:2014 Guidance for the preparation and quality management of fluids for haemodialysis and related therapies
    ISO 13959:2014 Water for haemodialysis and related therapies
    EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
    DIN EN 61010-1 : 2011 SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL AND LABORATORY USE - PART 1: GENERAL REQUIREMENTS
    EN 61010-1:2010 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    EN ISO 11663:2015 Quality of dialysis fluid for haemodialysis and related therapies (ISO 11663:2014)
    ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
    IEC 61010-1:2010+AMD1:2016 CSV Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements
    ISO 15223:2000 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied
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