Norm

NEN-EN-ISO 11663:2015 en

Kwaliteit van dialyse vloeistoffen voor hemodialyse en aanverwante therapieen

79,70

Over deze norm

Status Definitief
Aantal pagina's 17
Commissie Transfusie, infusie en injectieapparatuur voor medische toepassingen
Gepubliceerd op 01-11-2015
Taal Engels
NEN-EN-ISO 11663 specifies minimum quality requirements for dialysis fluids used in haemodialysis and related therapies. This International Standard includes dialysis fluids used for haemodialysis and haemodiafiltration, including substitution fluid for haemodiafiltration and haemofiltration. This International Standard does not address the requirements for the water and concentrates used to prepare dialysis fluid or the equipment used in its preparation. Those areas are covered by other International Standards. Sorbent-based dialysis fluid regeneration systems that regenerate and recirculate small volumes of dialysis fluid, systems for continuous renal replacement therapy that use prepackaged solutions, and systems and solutions for peritoneal dialysis are excluded from this International Standard.

Details

ICS-code 11.040.20
11.040.40
Nederlandse titel Kwaliteit van dialyse vloeistoffen voor hemodialyse en aanverwante therapieen
Engelse titel Quality of dialysis fluid for haemodialysis and related therapies
Vervangt
Normatieve verwijzingen
  • 93/42/EEG, Medische hulpmiddelen

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