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
| Edition : | 1st |
| File Size : | 1
file
, 800 KB |
| Number of Pages : | 92 |
| Product Code(s) : | 2421760, 2421767, 2421760 |
| Published : | 03/28/2012 |
| Same As : | CAN/CSA-ISO 8637:12 (R2017) |
