GUIDANCE FOR THE PREPARATION AND QUALITY MANAGEMENT OF FLUIDS FOR HAEMODIALYSIS AND RELATED THERAPIES

Available format(s)

Hardcopy , PDF

Language(s)

French, English

Published date

01-01-2016

Publisher

Canadian Standards Association

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

Specifies 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
ISBN	978-1-4883-03487
Pages	117
PublisherName	Canadian Standards Association
Status	Current
Supersedes	CSA Z23500 : 2012

Z364.6-17	Quality management for kidney dialysis providers
CSA Z364.2.1:2013	MONITORING SYSTEMS FOR HEMODIALYSIS EQUIPMENT
Z364.2.1-13 (R2018)	Monitoring systems for hemodialysis equipment

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
Z364.5-17	Safe installation and operation of hemodialysis and peritoneal dialysis in a home setting

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CSA Z23500 : 2016

GUIDANCE FOR THE PREPARATION AND QUALITY MANAGEMENT OF FLUIDS FOR HAEMODIALYSIS AND RELATED THERAPIES

Table of Contents

Abstract

General Product Information

Standards Referenced By This Book

Standards Referencing This Book

Category

Subcategory