STN EN ISO 23500-4
| Name: | STN EN ISO 23500-4 |
| Validity: | Valid |
| Number of pages: | 36 |
| Language: |
EN
|
| Paper: | 17,20€ |
| Electronic version |
a) Only read (without ability to print and copy)
15,48€ b) Without ability to print, with ability to copy (printscreen) 17,20€ c) With ability to print and copy (printscreen) 22,36€ |
| Slovak title | Príprava a riadenie kvality tekutín pre hemodialýzu a súvisiace terapie. Časť 4: Koncentráty pre hemodialyzované aplikácie a súvisiace terapie (ISO 23500-4: 2024) |
| English title | Preparation and quality management of fluids for haemodialysis and related therapies - Part 4: Concentrates for haemodialysis and related therapies (ISO 23500-4:2024) |
| Release Date: | 01. 09. 2024 |
| Date of withdrawal: | |
| ICS: | 11.040.40 |
| Sorting character/National clasification code | 85 6122 |
| Level of incorporation: | idt EN ISO 23500-4:2024, idt ISO 23500-4:2024 |
| Official Journal | 08/24 |
| Amendments | |
| Replaced by: | |
| Repleces: | STN EN ISO 23500-4:2019-08 (85 6122) |
| Note in Official Journal: | |
| Subject of the standard: | 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: — concentrates in both liquid and powder forms; — additives, also called spikes, which are chemicals that can be added to the concentrate to supplement or increase the concentration of one or more of the existing ions in the concentrate and thus in the final dialysis fluid; — equipment used to mix acid and bicarbonate powders into concentrate at the user's facility. This document does not apply to: — concentrates prepared from pre-packaged salts and water at a dialysis facility for use in that facility; — pre-packaged and sterile dialysis fluid; — sorbent dialysis fluid regeneration systems that regenerate and recirculate small volumes of the dialysis fluid; — equipment to perform patient treatment; this is addressed IEC 60601-2-16. |
| Preview: | Náhľad normy (PDF) |