ČSN EN ISO 8637-1 (856211)

Kategorie - podobné normy:

Implantáty pro chirurgii, protetiku a ortotiku

Anotace textu normy ČSN EN ISO 8637-1 (856211):

WARNING - Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard.

This document specifies requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators, hereinafter collectively referred to as "the device", for use in humans.

This document 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