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    I.S. EN ISO 13958:2015

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    Withdrawn A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
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    CONCENTRATES FOR HAEMODIALYSIS AND RELATED THERAPIES (ISO 13958:2014)

    Available format(s):  Hardcopy, PDF

    Withdrawn date:  30-09-2019

    Language(s):  English

    Published date:  20-12-2015

    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)

    National Foreword
    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
    Bibliography
    Annex ZA (informative) - Relationship between
             this European Standard and the Essential
             Requirements of EU Directive 93/42/EEC on
             medical devices

    Abstract - (Show below) - (Hide below)

    Provides minimum requirements for concentrates used for haemodialysis and related therapies.

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

    Development Note Supersedes I.S. EN 13867. (01/2016)
    Document Type Standard
    Publisher National Standards Authority of Ireland
    Status Withdrawn
    Superseded By

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

    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
    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
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    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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