CSA Preface
This is the first edition of CAN/CSA-Z8637, Cardiovascular implants and artificial organs - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators, which is an adoption, with Canadian deviations, of the identically titled ISO (International Organization for Standardization) Standard 8637 (second edition, 2004-10-01). It replaces the previous edition published in 1994 as CAN/CSA-Z364.1.1, Haemodialysers, Haemofilters and Haemoconcentrators (adopted ISO 8637:1989). At the time of publication, ISO 8637:2004 is available from ISO in English only. CSA will publish the French version when it becomes available from ISO.
1 Scope
This International Standard specifies requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators, hereinafter collectively referred to as "the device", for use for humans.
This lnternational 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 dialysate,
- 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.
| Edition : | 1st |
| File Size : | 1
file
, 1.3 MB |
| Note : | This product is unavailable in Russia, Ukraine, Belarus |
| Number of Pages : | 42 |
| Published : | 03/01/2008 |
