CSA Z364.2.2 : 2003
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
WATER TREATMENT EQUIPMENT AND WATER QUALITY REQUIREMENTS FOR HEMODIALYSIS
Hardcopy , PDF
23-07-2013
CSA ISO 11663 : 2015
CSA ISO 26722 : 2016
CSA ISO 13959 : 2011
English
01-01-2003
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Preface
1 Scope
2 Reference Publications
3 Definitions
4 Water Quality
4.1 Feed Water
4.2 Product Water
4.2.1 Microbial Count and Endotoxin Concentration
4.2.2 Chemical Requirements
5 Water Treatment Equipment
5.1 Feed Water
5.2 Product Water
5.3 Sanitization of Water Treatment and Distribution Equipment
5.4 Deionization
5.5 Electrodialysis
5.6 Reverse Osmosis
5.7 Filters and Ultrafilters
5.8 Carbon Adsorption Media
5.9 Automatic Water Pre-treatment Devices
5.10 Storage Tanks
6 Safety
6.1 General
6.2 Electrical Safety
6.3 Automatic Disinfection
7 Labelling and Documentation
7.1 Water Treatment Equipment Labels
7.2 Operating and Service Manual
7.3 Records
8 Tests
8.1 Tests of Product Water Quality
8.1.1 Bacteriology
8.1.2 Inorganics
8.1.3 Organics
8.1.4 Pyrogens
8.2 Compliance with Water Treatment Equipment Requirements
8.2.1 Test for Materials Compatibility
8.2.2 Test for Residual Sanitizing Agents
8.2.3 Tests Related to Product Water from Deionization
8.2.4 Tests Related to Product Water from Electrodialysis
8.2.5 Tests Related to Reverse Osmosis Monitoring Systems
8.2.6 Filter Inspection
8.2.7 Carbon Adsorption Media
8.2.8 Ultraviolet Irradiators
9 Verification of Equipment Installation and Operation
Tables
Annexes
A (normative) - Guidelines for Chemical and Physical Parameters
for Feed Water
B (informative) - Bibliography
Applies to a) acute, chronic, and home-based hemodialysis; b) water for preparing dialyzing fluid and concentrate for hemodialysis; c) all water intended for contact with the dialyzing fluid pathway; d) the baseline quality of the feed water and any other input water; e) water treatment and monitoring equipment; f) water distribution systems; and g) product water used for flushing blood pathways before sterilization (but not afterwards).
| DocumentType |
Standard
|
| Pages |
36
|
| PublisherName |
Canadian Standards Association
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| CSA Z441 : 1988 | TERMINOLOGY AND DEFINITIONS USED IN CSA HEALTH CARE TECHNOLOGY STANDARDS |
| CSA Z364.1.1-Z364.1.2 : 0 | HAEMODIALYZERS, HAEMOFILTERS, AND HAEMOCONCENTRATORS/EXTRACORPOREAL BLOOD CIRCUIT FOR HAEMODIALYZERS, HAEMOFILTERS, AND HAEMOCONCENTRATORS |
| CSA Z364.1.3 : 1998 : R2014 | REUSE OF HAEMODIALYSERS |
| CSA Z8637 : 2008 | CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS AND HAEMOCONCENTRATORS |
| CSA Z364.1.1 : M84 | HEMODIALYSERS, HEMOFILTERS AND HEMOCONCENTRATORS |
| CSA Z364.1.2 : M84 | EXTRACORPOREAL CIRCUITS FOR USE WITH A HEMODIALYSER, HEMOFILTER, AND HEMOCONCENTRATOR |
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