• 17/30321193 DC : 0

    NA Status of Standard is Unknown

    BS ISO 23500-1 - GUIDANCE FOR THE PREPARATION AND QUALITY MANAGEMENT OF FLUIDS FOR HAEMODIALYSIS AND RELATED THERAPIES - PART 1. GENERAL REQUIREMENTS

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date: 

    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 Summary of quality requirements of
       ISO 23500-4, ISO 23500-3 and ISO 23500-5
    5 Critical aspects of system design
    6 Validation of system performance
    7 Quality management
    8 Strategies for microbiological control
    9 Location of and access to water treatment system
    10 Personnel
    Annex A (informative) - Rationale for the
            development and provisions of this
            International Standard
    Annex B (informative) - Equipment
    Annex C (informative) - Monitoring guidelines
            for water treatment equipment, distribution
            systems, and dialysis fluid
    Annex D (informative) - Strategies for microbiological
            control
    Annex E (informative) - Validation
    Annex F (informative) - Special considerations for
            home haemodialysis
    Annex G (informative) - Special considerations for
            acute haemodialysis
    Bibliography

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

    Comment Closes On
    Committee CH/150/2
    Document Type Draft
    Publisher British Standards Institution
    Status NA

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

    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
    IEC 60529:1989+AMD1:1999+AMD2:2013 CSV Degrees of protection provided by enclosures (IP Code)
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