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  • AAMI ISO 13958 : 2009

    View superseded by
    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 HEMODIALYSIS AND RELATED THERAPIES

    Available format(s):  Hardcopy, PDF

    Superseded date:  30-09-2014

    Language(s):  English

    Published date:  01-01-2009

    Publisher:  Association for the Advancement of Medical Instrumentation

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

    Glossary of equivalent standards
    Committee representation
    Background of US adoption of ISO 13958:2009
    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Requirements
    5 Tests
    6 Labeling
    Annex A (informative) - Rationale for the development and
                            provisions of this International
                            Standard
    Bibliography

    Abstract - (Show below) - (Hide below)

    Describes minimum requirements for concentrates used for hemodialysis and related therapies.

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

    Committee RD
    Development Note Supersedes AAMI RD61. (06/2011)
    Document Type Standard
    Publisher Association for the Advancement of Medical Instrumentation
    Status Superseded
    Superseded By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 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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