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I.S. EN ISO 23500:2015

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

GUIDANCE FOR THE PREPARATION AND QUALITY MANAGEMENT OF FLUIDS FOR HAEMODIALYSIS AND RELATED THERAPIES (ISO 23500:2014)
Available format(s)

Hardcopy , PDF

Superseded date

04-12-2019

Language(s)

English

Published date

01-01-2015

Preview

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.

National Foreword
European foreword
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Summary of quality requirements of ISO 13958,
   ISO 13959 and ISO 11663
5 Critical aspects of system design
6 Validation of system performance
7 Quality management
8 Strategies for microbiological control
9 Environment
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

Gives dialysis practitioners with guidance on the preparation of dialysis fluid for haemodialysis and related therapies and substitution fluid for use in online therapies, such as haemodiafiltration and haemofiltration.

DocumentType
Standard
Pages
102
PublisherName
National Standards Authority of Ireland
Status
Superseded
SupersededBy

Standards Relationship
EN ISO 23500:2015 Identical
ISO 23500:2014 Identical

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
ISO 13958:2014 Concentrates for haemodialysis and related therapies
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 26722:2014 Water treatment equipment for haemodialysis applications and related therapies
IEC 60529:1989+AMD1:1999+AMD2:2013 CSV Degrees of protection provided by enclosures (IP Code)
ISO 13959:2014 Water for haemodialysis and related therapies

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US$135.93
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