CSA Z23500 : 2016
Current
The latest, up-to-date edition.
GUIDANCE FOR THE PREPARATION AND QUALITY MANAGEMENT OF FLUIDS FOR HAEMODIALYSIS AND RELATED THERAPIES
Hardcopy , PDF
French, English
01-01-2016
Important note : Users cannot be edited or removed once added to your Multi user PDF.
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 |
| 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 |
| 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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