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Publications CAN/CSA-ISO 8637:12 (R2017)

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CAN/CSA-ISO 8637:12 (R2017) - Cardiovascular implants and extracorporeal systems - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (Adopted ISO 8637:2010, third edition, 2010-07-01)

Publication Year:

  • 2012

Total Pages:

34

Reaffirmed Year:

  • 2017

Publisher:

  • CSA

CSA Preface

This is the first edition of CAN/CSA-ISO 8637, Cardiovascular implants and extracorporeal systems - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators, which is an adoption, without modification, of the identically titled ISO (International Organization for Standardization) Standard 8637 (third edition, 2010-07-01).

It replaces the previous edition published in 2008 as CAN/CSA-Z8637, Cardiovascular implants and artificial organs - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (adopted ISO 8637:2004).

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.

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