STN EN ISO 23500-4
| Označenie: | STN EN ISO 23500-4 |
| Platnosť: | Platná |
| Počet strán: | 36 |
| Jazyk: |
EN
|
| Listinná verzia: | 17,20€ |
| Elektronická verzia: |
a) Bez možnosti tlače, prenosu textu a obrázkov:
15,48€ b) Bez možnosti tlače, s prenosom textu a obrázkov: 17,20€ c) S možnosťou tlače, prenosu textu a obrázkov: 22,36€ |
| Slovenský názov: | Príprava a riadenie kvality tekutín pre hemodialýzu a súvisiace terapie. Časť 4: Koncentráty pre hemodialyzované aplikácie a súvisiace terapie (ISO 23500-4: 2024) |
| Anglický názov: | Preparation and quality management of fluids for haemodialysis and related therapies - Part 4: Concentrates for haemodialysis and related therapies (ISO 23500-4:2024) |
| Dátum vydania: | 01. 09. 2024 |
| Dátum zrušenia: | |
| ICS: | 11.040.40 |
| Triediaci znak: | 85 6122 |
| Úroveň zapracovania: | idt EN ISO 23500-4:2024, idt ISO 23500-4:2024 |
| Vestník: | 08/24 |
| Zmeny: | |
| Nahradzujúce normy: | |
| Nahradené normy: | STN EN ISO 23500-4:2019-08 (85 6122) |
| Poznámka vo Vestníku: | |
| Predmet normy: | 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. |
| Náhľad normy: | Náhľad normy (PDF) |