Name:
ISO 8637-1:2017 PDF
Published Date:
11/01/2017
Status:
Active
ISO 8637-1:2017 specifies requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators, hereinafter collectively referred to as "the device", for use in humans.
ISO 8637-1:2017 does not apply 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 or equipment intended 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 8637-2.
| File Size : | 1 file , 480 KB |
| Note : | This product is unavailable in Ukraine, Russia, Belarus |
| Number of Pages : | 30 |
| Published : | 11/01/2017 |
| Same As : | ISO 8637-1:2017 |
