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  • BS EN ISO 13958:2015

    View superseded by
    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    Concentrates for haemodialysis and related therapies

    Available format(s):  Hardcopy, PDF

    Superseded date:  27-03-2019

    Language(s):  English

    Published date:  31-12-2015

    Publisher:  British Standards Institution

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

    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)

    Committee CH/150/2
    Development Note Supersedes BS EN 13867 & 13/30270468 DC. (12/2015)
    Document Type Standard
    Publisher British Standards Institution
    Status Superseded
    Superseded By
    Supersedes

    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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