STN EN ISO 11608-2
| Označenie: | STN EN ISO 11608-2 |
| Platnosť: | Platná |
| Počet strán: | 44 |
| 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 2: Ihly (ISO 11608-2: 2022) |
| Anglický názov: | Needle-based injection systems for medical use - Requirements and test methods - Part 2: Double-ended pen needles (ISO 11608-2:2022) |
| Dátum vydania: | 01. 08. 2022 |
| Dátum zrušenia: | |
| ICS: | 11.040.25 |
| Triediaci znak: | 85 5930 |
| Úroveň zapracovania: | idt EN ISO 11608-2:2022, idt ISO 11608-2:2022 |
| Vestník: | 07/22 |
| Zmeny: | |
| Nahradzujúce normy: | |
| Nahradené normy: | STN EN ISO 11608-2:2012-08 (85 5930) |
| Poznámka vo Vestníku: | |
| Predmet normy: | This document specifies requirements and test methods for single-use, double-ended, sterile needles intended to be used with some needle-based injection systems (NISs) that use a non-integrated double-ended needle according to ISO 11608-1. This document is not applicable to the following: — needles for dental use; — pre-attached syringe needles; — hypodermic needles; — needles intended for different routes of administration (e.g. intravenous, intrathecal, intraocular); — materials that form the medicinal product contact surfaces of the primary container closure. However, while this document is not intended to directly apply to these needle products, it does contain requirements and tests methods that can be used to help design and evaluate them. NOTE Needles provided by the manufacturer integrated into the fluid path or container are covered in ISO 11608-3, and hypodermic needles provided separately are covered in ISO 7864. |
| Náhľad normy: | Náhľad normy (PDF) |