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  • 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)

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    Published date:  15-04-2020

    Publisher:  Comite Europeen de Normalisation

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    Abstract - (Show below) - (Hide below)

    ISO 8637-1:2017 specifies requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators, hereinafter collectively referred to as "the device", for use in humans.ISO 8637-1:2017 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.

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    Committee CEN/TC 205
    Document Type Standard
    Publisher Comite Europeen de Normalisation
    Status Current
    Supersedes
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