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ČSN EN ISO 8637-2 (856211)
Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
Translate name
STANDARD published on 1.2.2019
The information about the standard:
Designation standards: ČSN EN ISO 8637-2
Classification mark: 856211
Catalog number: 506165
Publication date standards: 1.2.2019
SKU: NS-935655
The number of pages: 32
Approximate weight : 96 g (0.21 lbs)
Country: Czech technical standard
Category: Technical standards ČSN
The category - similar standards:
Annotation of standard text ČSN EN ISO 8637-2 (856211):
WARNING - Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this document. This document specifies requirements for the blood circuit for devices used in extracorporeal blood filtration therapies such as, but not limited to, haemodialysis, haemodiafiltration, haemofiltration and transducer protectors (integral and non-integral) intended for use in such circuits. This document does not apply to: - haemodialysers, haemodiafilters or haemofilters; - 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. NOTE 1: Requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators are specified in ISO 8637-1, and requirements for plasmafilters are specified in ISO 8637-3. NOTE 2: Extracorporeal blood tubing sets can also be used for other extracorporeal therapies such as haemoperfusion, plasmafiltration and plasma adsorption
Preview of the standard ČSN EN ISO 8637-2 (856211)
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