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
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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.
| DocumentType |
Standard
|
| Pages |
22
|
| PublisherName |
International Organization for Standardization
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| DS/ISO 23500-4:2024 | Identical |
| NS-EN ISO 23500-4:2024 | Identical |
| DS/EN ISO 23500-4:2024 | Identical |
| UNI EN ISO 23500-4:2024 | Identical |
| SN EN ISO 23500-4:2024 | Identical |
| SS-EN ISO 23500-4:2024 | Identical |
| PN-EN ISO 23500-4:2024-10 | Identical |
| ÖNORM EN ISO 23500-4:2024 10 01 | Identical |
| BS EN ISO 23500-4:2024 | Identical |
| PNE-EN ISO 23500-4 | Identical |
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