CSA Z364.1.1-Z364.1.2 : 0

Technical Committee on Extracorporeal Circulation
Technology
Subcommittee on Kidney Dialysis
Task Force on Haemodialysers
CSA Preface
CSA Reference Publications
Z364.1.1-94 (ISO 8637:1989),
Haemodialysers, haemofilters and haemoconcentrators
Canadian Deviations and Editorial Changes
Foreword
Introduction
1 Scope
2 Normative References
3 Definitions
   3.1 Arterial Blood Circuit
   3.2 Blood Compartment Volume; Volume of the Blood
         Compartment
   3.3 Blood Flow Rate
   3.4 Clearance
   3.5 Clotted Residual Blood
   3.6 Compliance
   3.7 Dialysance
   3.8 Dialysate; Dialysing Fluid
   3.9 Dialysing Fluid Compartment Volume; Volume of
         the Diaylsing Fluid Compartment
   3.10 Dialysing Fluid Addition Rate
   3.11 Dialysing Fluid Flow Rate
   3.12 Dialysing Fluid Recirculation Rate
   3.13 Distributor
   3.14 Filtrate
   3.15 Fluid Residual Blood
   3.16 Haemoconcentration
   3.17 Haemoconcentrator
   3.18 Haemodialyser
   3.19 Haemodialysis
   3.20 Haemofilter
   3.21 Haemofiltration
   3.22 Hydraulic Resistance
   3.23 Manufacturer
   3.24 Mean Coiled Pressure (MCP)
   3.25 Non-Pyrogenic
   3.26 Recirculation System
   3.27 Recirculation Single-Pass System
   3.28 Residual Blood
   3.29 Semi-Permeable Membrane
   3.30 Single-Pass Dialysing Fluid System
   3.31 Sterile
   3.32 Transmembrane Pressure (TMP)
   3.33 User
   3.34 Venous Blood Circuit
4 Requirements
   4.1 Good Manufacturing Practice
   4.2 Toxicology and Biological Compatibility
   4.3 Sterility
   4.4 Pyrogenicity
   4.5 Residues from Sterilization
   4.6 Mechanical Characteristics
   4.7 Disclosure of Performance Characteristics
5 Test Methods
   5.1 Good Manufacturing Practice
   5.2 Toxicology and Biological Compatibility
   5.3 Sterility
   5.4 Pyrogenicity
   5.5 Residues from Sterilization
   5.6 Mechanical Characteristics
6 Packaging, Marking and Accompanying Documentation
   6.1 Packaging and Marking
   6.2 Documentation
Annex A - Test to Check Validity of Membrane Integrity
          Test
Z364.1.2-94 (ISO 8638:1989),
Extracorporeal blood circuit for haemodialysers,
haemofilters and haemoconcentrators
Canadian Deviations and Editorial Changes
Foreword
Introduction
1 Scope
2 Normative References
3 Definitions
   3.1 Arterial Blood Circuit
   3.2 Non-Pyrogenic
   3.3 Pump Segment
   3.4 Sterile
   3.5 Venous Blood Circuit
4 Requirements
   4.1 Good Manufacturing Practice
   4.2 Toxicology and Biological Compatibility
   4.3 Sterility
   4.4 Pyrogenicity
   4.5 Residues from Sterilization
   4.6 Mechanical Characteristics
   4.7 Physical Characteristics
5 Test Methods
   5.1 Good Manufacturing Practice
   5.2 Toxicology and Biological Compatibility
   5.3 Sterility
   5.4 Pyrogenicity
   5.5 Residues from Sterilization
   5.6 Mechanical Characteristics
   5.7 Physical Characteristics
6 Packaging, Marking and Accompanying Documentation
   6.1 Packaging and Marking
   6.2 Documentation

Specifies requirements for haemodialysers, including those of coil, hollow fibre and parallel plate design, haemofilters and haemoconcentrators for single use for humans.