STN EN ISO 11608-1
| Označenie: | STN EN ISO 11608-1 |
| Platnosť: | Platná |
| Počet strán: | 84 |
| 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 1: Injekčné systémy na báze ihiel (ISO 11608-1: 2022) |
| Anglický názov: | Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems (ISO 11608-1:2022) |
| Dátum vydania: | 01. 08. 2022 |
| Dátum zrušenia: | |
| ICS: | 11.040.25 |
| Triediaci znak: | 85 5930 |
| Úroveň zapracovania: | idt EN ISO 11608-1:2022, idt ISO 11608-1:2022 |
| Vestník: | 07/22 |
| Zmeny: | |
| Nahradzujúce normy: | |
| Nahradené normy: | STN EN ISO 11608-1:2015-07 (85 5930) |
| Poznámka vo Vestníku: | |
| Predmet normy: | This document specifies requirements and test methods for Needle-Based Injection Systems (NISs) for single-patient use intended to deliver discrete volumes (bolus) of medicinal product, which can be delivered through needles or soft cannulas for intradermal, subcutaneous and/or intramuscular delivery, incorporating pre-filled or user-filled, replaceable or non-replaceable containers. This document applies in cases where the NIS incorporates a prefilled syringe. However, stand-alone prefilled syringes defined by ISO 11040-8 are not covered by this document (see exclusions below). It is important to note that other functions and characteristics of the prefilled syringe, such as dose accuracy, are subject to the requirements (delivered volume) in ISO 11040-8 and not this document, unless the addition impacts the delivery function (e.g. a mechanism that intends to restrict or stop the plunger movement, which would limit the dose delivered). |
| Náhľad normy: | Náhľad normy (PDF) |