ISO 23500-4:2024
Current
The latest, up-to-date edition.
Preparation and quality management of fluids for haemodialysis and related therapies — Part 4: Concentrates for haemodialysis and related therapies
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
English, French
17-04-2024
This document specifies the chemical and microbiological requirements for concentrates used for haemodialysis and related therapies and applies to the manufacturer of such concentrates.
This document is applicable to:
equipment to perform patient treatment; this is addressed IEC 60601-2-16.
This document does not cover the dialysis fluid that is used to clinically dialyse patients. Dialysis fluid is covered in ISO23500-5. The making of dialysis fluid involves the proportioning of concentrate and water at the bedside or in a central dialysis fluid delivery system. Although the label requirements for dialysis fluid are placed on the labelling of the concentrate, it is the user's responsibility to ensure proper use.
Important note : Users cannot be edited or removed once added to your Multi user PDF.Access your standards online with a subscription
Features
-
Simple online access to standards, technical information and regulations.
-
Critical updates of standards and customisable alerts and notifications.
-
Multi-user online standards collection: secure, flexible and cost effective.