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;
- 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.
Status: Under developmentYou can help develop this draft international standard by contacting your national member
Edition: 2Number of pages: 34
Technical Committee: ISO/TC 150/SC 2 Cardiovascular implants and extracorporeal systems
- ICS :
- 11.040.40 Implants for surgery, prosthetics and orthotics
This standard contributes to the following Sustainable Development Goal:
Buy this standard
|std 1 61|
|std 2 61||Paper|
ISO/DIS 8637-1Stage: 40.20
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