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Publications CAN/CSA-ISO 8638:12 (R2017)

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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)

Publication Year:

  • 2012

Total Pages:

30

Reaffirmed Year:

  • 2017

Publisher:

  • CSA

CSA Preface

This is the first edition of CAN/CSA-ISO 8638, Cardiovascular implants and extracorporeal systems - Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters, which is an adoption, without modification, of the identically titled ISO (International Organization for Standardization) Standard 8638 (third edition, 2010-07-01). It replaces the previous edition published in 2008 as CAN/CSA-Z8638, Cardiovascular implants and artificial organs - Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (adopted ISO 8638:2004).

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.

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QST REG No R1006017360