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EVS-EN ISO 8637-1:2020

Südame-veresoonkonna implantaadid ja kehavälised süsteemid. Osa 1: Hemodialüsaatorid, verelahutusfiltrid, verefiltrid ja verekontsentreerijad

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Kehtiv alates 04.05.2020
Alusdokumendid
ISO 8637-1:2017; EN ISO 8637-1:2020
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04.05.2020
Põhitekst
04.02.2014
Põhitekst
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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