STN EN ISO 11608-3
Označenie: | STN EN ISO 11608-3 |
Platnosť: | Platná |
Počet strán: | 40 |
Jazyk: |
EN
|
Listinná verzia: | 18,90€ |
Elektronická verzia: |
a) Bez možnosti tlače, prenosu textu a obrázkov:
17,01€ b) Bez možnosti tlače, s prenosom textu a obrázkov: 18,90€ c) S možnosťou tlače, prenosu textu a obrázkov: 24,57€ |
Slovenský názov: | Injekčné systémy na báze ihiel na zdravotnícke použitie. Požiadavky a skúšobné metódy. Časť 3: Zásobníky a integrované dráhy tekutín (ISO 11608-3: 2022, opravená verzia 2023-01) |
Anglický názov: | Needle-based injection systems for medical use - Requirements and test methods - Part 3: Containers and integrated fluid paths (ISO 11608-3:2022, Corrected version 2023-01) |
Dátum vydania: | 01. 03. 2024 |
Dátum zrušenia: | |
ICS: | 11.040.25 |
Triediaci znak: | 85 5930 |
Úroveň zapracovania: | idt EN ISO 11608-3:2022, idt ISO 11608-3 Corrected version 2023-01:2022 |
Vestník: | 02/24 |
Zmeny: | |
Nahradzujúce normy: | |
Nahradené normy: | STN EN ISO 11608-3:2022-08 (85 5930) |
Poznámka vo Vestníku: | |
Predmet normy: | This document specifies requirements and test methods for design verification of containers and integrated fluid paths used with Needle-Based Injection Systems (NISs) according to ISO 11608-1. It is applicable to single and multi-dose containers either filled by the manufacturer (primary container closure) or by the end-user (reservoir) (e.g. cartridges, syringes) and fluid paths that are integrated with the NIS at the point of manufacture. This document is also applicable to prefilled syringes (see ISO 11040-8) when used with a NIS (see also scope of ISO 11608-1:2022). This document is not applicable to the following products: — sterile hypodermic needles; — sterile hypodermic syringes; — sterile single-use syringes, with or without needle, for insulin; — containers that can be refilled multiple times; — containers intended for dental use; — catheters or infusion sets that are attached or assembled separately by the user. |
Náhľad normy: | Náhľad normy (PDF) |