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ČSN EN ISO 8637-1 (856211)
Extracorporeal systems for blood purification - Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
Translate name
STANDARD published on 1.10.2020
The information about the standard:
Designation standards: ČSN EN ISO 8637-1
Classification mark: 856211
Catalog number: 510484
Publication date standards: 1.10.2020
SKU: NS-1005914
The number of pages: 36
Approximate weight : 108 g (0.24 lbs)
Country: Czech technical standard
Category: Technical standards ČSN
The category - similar standards:
Annotation of standard text 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
Preview of the standard ČSN EN ISO 8637-1 (856211)
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