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CAN/CSA-ISO 8638:12 (R2017)

Cardiovascular implants and extracorporeal systems - Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (Adopted ISO 8638:2010, third edition, 2010-07-01)

standard by Canada National Standard/Canadian Standards - ISO , 03/27/2012

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Full Description

Scope

This International Standard specifies requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (hereafter referred to as "the device") and (integral and non-integral) transducer protectors which are intended for use in haemodialysis, haemodiafiltration and haemofiltration.

This International Standard does not apply to:
  • haemodialysers, haemodiafilters or haemofilters;
  • 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 or equipment intended to perform haemodialysis, haemodiafiltration, haemofiltration or haemoconcentration.


NOTE Requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators are specified in ISO 8637.
 

Product Details

Edition:
1st
Published:
03/27/2012
Number of Pages:
30
File Size:
1 file , 750 KB
Same As:
ISO 8638:2010
Product Code(s):
2421768, 2421761, 2421761