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SNV - SN EN ISO 8637

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

active, Most Current
Organization: SNV
Publication Date: 1 April 2014
Status: active
Page Count: 36
ICS Code (Transfusion, infusion and injection equipment): 11.040.20
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

SN EN ISO 8637
April 1, 2014
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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