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CSA - CAN/CSA-ISO 8637:12

Cardiovascular implants and extracorporeal systems - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators

active
Organization: CSA
Publication Date: 1 January 2012
Status: active
Page Count: 34
ICS Code (Implants for surgery, prosthetics and orthotics): 11.040.40
scope:

This International Standard specifies requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators, hereinafter collectively referred to as "the device", for use in humans.

This International Standard is not applicable to:

⎯ extracorporeal blood circuits;

⎯ plasmafilters;

⎯ haemoperfusion devices;

⎯ vascular access devices;

⎯ blood pumps;

⎯ pressure monitors for the extracorporeal blood circuit;

⎯ air detection devices;

⎯ systems to prepare, maintain or monitor dialysis fluid;

⎯ systems used to perform haemodialysis, haemodiafiltration, haemofiltration or haemoconcentration;

⎯ reprocessing procedures and equipment.

NOTE Requirements for the extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters are specified in ISO 8638.

Document History

January 1, 2015
Cardiovascular implants and extracorporeal systems - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators AMENDMENT 1: Revision to Figure 2 - Main fitting dimensions of dialysis fluid inlet and outlet ports
Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is...
March 1, 2012
Cardiovascular implants and extracorporeal systems — Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
This International Standard specifies requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators, hereinafter collectively referred to as "the device", for use in humans....
January 1, 2012
Cardiovascular implants and extracorporeal systems - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators AMENDMENT 1: Revision to Figure 2 - Main fitting dimensions of dialysis fluid inlet and outlet ports
A description is not available for this item.
CAN/CSA-ISO 8637:12
January 1, 2012
Cardiovascular implants and extracorporeal systems - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
This International Standard specifies requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators, hereinafter collectively referred to as “the device”, for use in humans....

References

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