STN EN ISO 11608-4
| Označenie: | STN EN ISO 11608-4 |
| Platnosť: | Platná |
| Počet strán: | 76 |
| Jazyk: |
EN
|
| Listinná verzia: | 28,80€ |
| Elektronická verzia: |
a) Bez možnosti tlače, prenosu textu a obrázkov:
25,92€ b) Bez možnosti tlače, s prenosom textu a obrázkov: 28,80€ c) S možnosťou tlače, prenosu textu a obrázkov: 37,44€ |
| Slovenský názov: | Injekčné systémy na báze ihiel na zdravotnícke použitie. Požiadavky a skúšobné metódy. Časť 4: Injekčné systémy na báze ihiel obsahujúce elektroniku (ISO 11608-4: 2022) |
| Anglický názov: | Needle-based injection systems for medical use - Requirements and test methods - Part 4: Needle-based injection systems containing electronics (ISO 11608-4:2022) |
| Dátum vydania: | 01. 08. 2022 |
| Dátum zrušenia: | |
| ICS: | 11.040.25 |
| Triediaci znak: | 85 5930 |
| Úroveň zapracovania: | idt EN ISO 11608-4:2022, idt ISO 11608-4:2022 |
| Vestník: | 07/22 |
| Zmeny: | |
| Nahradzujúce normy: | |
| Nahradené normy: | STN EN ISO 11608-4:2008-02 (85 5930) |
| Poznámka vo Vestníku: | |
| Predmet normy: | This document specifies requirements and test methods for needle-based injection systems (NISs) containing electronics with or without software (NIS-Es). The needle-based injection system containing electronics can be single use or reusable and can be operated with or without electrical/conductive connections to other devices. The system is intended to deliver medication to a patient by self-administration or by administration by one other operator (e.g. caregiver or health care provider). This document applies to electronic accessories that are intended to be physically connected to a NIS or NIS-E according to the NIS/NIS-E intended use. This document also applies to electronic accessories that are intended to have electrical/conductive connections to a NIS or NIS-E according to the NIS/NIS-E intended use. |
| Náhľad normy: | Náhľad normy (PDF) |