60.60 Standard published Apr 24, 2024
CEN
CEN/TC 205 Non-active medical devices
European Norm
11.040.40 Implants for surgery, prosthetics and orthotics
Published
This document specifies the minimum chemical and microbiological quality requirements for dialysis fluids used in haemodialysis and related therapies.
This document applies to
— dialysis fluids used for haemodialysis and haemodiafiltration,
— substitution fluid produced online for haemodiafiltration and haemofiltration based on dialysis fluid
This document does not apply to
— the water and concentrates used to prepare dialysis fluid or the equipment to produce dialysis fluid
— sorbent-based dialysis fluid regeneration systems that regenerate and recirculate small volumes of dialysis fluid,
— systems for continuous renal replacement therapy that use pre-packaged solutions, and
— systems and solutions for peritoneal dialysis.
The delivery and monitoring of the dialysis fluid composition and its permitted deviation from set points is governed by protective systems defined in IEC 60601-2-16.
WITHDRAWN
EN ISO 23500-5:2019
PUBLISHED
EN ISO 23500-5:2024
60.60
Standard published
Apr 24, 2024
