STN EN ISO 21649
| Označenie: | STN EN ISO 21649 |
| Platnosť: | Platná |
| Počet strán: | 52 |
| Jazyk: |
EN
|
| Listinná verzia: | 21,40€ |
| Elektronická verzia: |
a) Bez možnosti tlače, prenosu textu a obrázkov:
19,26€ b) Bez možnosti tlače, s prenosom textu a obrázkov: 21,40€ c) S možnosťou tlače, prenosu textu a obrázkov: 27,82€ |
| Slovenský názov: | Bezihlové injekčné systémy na zdravotnícke účely. Požiadavky a skúšobné metódy (ISO 21649: 2023) |
| Anglický názov: | Needle-free injection systems for medical use - Requirements and test methods (ISO 21649:2023) |
| Dátum vydania: | 01. 05. 2023 |
| Dátum zrušenia: | |
| ICS: | 11.040.20 |
| Triediaci znak: | 85 6230 |
| Úroveň zapracovania: | idt EN ISO 21649:2023, idt ISO 21649:2023 |
| Vestník: | 04/23 |
| Zmeny: | |
| Nahradzujúce normy: | |
| Nahradené normy: | STN EN ISO 21649:2010-01 (85 6230) |
| Poznámka vo Vestníku: | |
| Predmet normy: | This document applies to safety and performance and testing requirements for single-use and multiple-use Needle-Free Injection Systems (NFISs) intended for human use in clinics and other medical settings and for personal use by patients. The dose chamber of the NFIS is often disposable and intended to be replaced after either a single use or a limited number of uses. It is sometimes separable from the injection mechanism and often termed a “cartridge”, “ampoule”, “syringe”, “capsule” or “disc”. In contrast, the dose chamber can also incorporate a permanent internal chamber designed to last through the claimed life of the device, and an additional member or members which eliminate the risk of cross-contamination. |
| Náhľad normy: | Náhľad normy (PDF) |