UNE-EN ISO 8637-1:2020
Current
The latest, up-to-date edition.
Extracorporeal systems for blood purification - Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637-1:2017)
Hardcopy , PDF
Spanish, Castilian, English
21-10-2020
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 does not apply to:
¾ð extracorporeal blood circuits;
¾ð plasmafilters;
¾ð haemoperfusion devices;
¾ð vascular access devices;
¾ð blood pumps;
¾ð pressure monitors for the extracorporeal blood circuit;
¾ð air detection devices;
¾ð systems to prepare, maintain or monitor dialysis fluid;
¾ð systems or equipment intended to perform haemodialysis, haemodiafiltration, haemofiltration or
haemoconcentration.
¾ð reprocessing procedures and equipment.
NOTE Requirements for the extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters are
specified in ISO 8637-2.
| Committee |
CTN 111
|
| DocumentType |
Standard
|
| Pages |
32
|
| PublisherName |
Asociación Española de Normalización
|
| Status |
Current
|
| Standards | Relationship |
| EN ISO 8637-1:2020 | Identical |
| BS 1846-2:1968 | Identical |
| ISO 8637-1:2017 | Identical |
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