Standard Svensk standard · SS-EN ISO 8637-1:2020

Extrakorporeala system för blodrening - Del 1:Hemodialysatorer, hemodialysfilter, dialysfilter och hemokoncentratorer (ISO 8637-1:2017)

Status: Gällande

Omfattning
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.

Ämnesområden

Utrustning för transfusion, infusion och injektion (11.040.20) Kirurgiska implantat, proteser och ortoser (11.040.40)


Produktinformation

Språk: Engelska

Framtagen av: Förbrukningsmaterial inom sjukvården, SIS/TK 330

Internationell titel: Extracorporeal systems for blood purification - Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637-1:2017)

Artikelnummer: STD-80021471

Utgåva: 1

Fastställd: 2020-04-21

Antal sidor: 32

Ersätter: SS-EN ISO 8637:2014