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Norm

ÖNORM EN ISO 8638

Issue date: 2014 03 01

Cardiovascular implants and extracorporeal systems - Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (ISO 8638:2010)

This International Standard specifies requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (hereafter referred to as "the device") and (...
Withdrawn: 2018 11 15
Publisher:
Austrian Standards International
Format:
Digital | 21 Pages
Language:
German | English
Optionally co-design standards:
This International Standard specifies requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (hereafter referred to as "the device") and (integral and non-integral) transducer protectors which are intended for use in haemodialysis, haemodiafiltration and haemofiltration. This International Standard 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.
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