STN EN ISO 21649
| Name: | STN EN ISO 21649 |
| Validity: | Valid |
| Number of pages: | 52 |
| Language: |
EN
|
| Paper: | 21,40€ |
| Electronic version |
a) Only read (without ability to print and copy)
19,26€ b) Without ability to print, with ability to copy (printscreen) 21,40€ c) With ability to print and copy (printscreen) 27,82€ |
| Slovak title | Bezihlové injekčné systémy na zdravotnícke účely. Požiadavky a skúšobné metódy (ISO 21649: 2023) |
| English title | Needle-free injection systems for medical use - Requirements and test methods (ISO 21649:2023) |
| Release Date: | 01. 05. 2023 |
| Date of withdrawal: | |
| ICS: | 11.040.20 |
| Sorting character/National clasification code | 85 6230 |
| Level of incorporation: | idt EN ISO 21649:2023, idt ISO 21649:2023 |
| Official Journal | 04/23 |
| Amendments | |
| Replaced by: | |
| Repleces: | STN EN ISO 21649:2010-01 (85 6230) |
| Note in Official Journal: | |
| Subject of the standard: | 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. |
| Preview: | Náhľad normy (PDF) |