STN EN ISO 11608-3
| Name: | STN EN ISO 11608-3 |
| Validity: | Valid |
| Number of pages: | 40 |
| Language: |
EN
|
| Paper: | 18,90€ |
| Electronic version |
a) Only read (without ability to print and copy)
17,01€ b) Without ability to print, with ability to copy (printscreen) 18,90€ c) With ability to print and copy (printscreen) 24,57€ |
| Slovak title | 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) |
| English title | 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) |
| Release Date: | 01. 03. 2024 |
| Date of withdrawal: | |
| ICS: | 11.040.25 |
| Sorting character/National clasification code | 85 5930 |
| Level of incorporation: | idt EN ISO 11608-3:2022, idt ISO 11608-3 Corrected version 2023-01:2022 |
| Official Journal | 02/24 |
| Amendments | |
| Replaced by: | |
| Repleces: | STN EN ISO 11608-3:2022-08 (85 5930) |
| Note in Official Journal: | |
| Subject of the standard: | 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. |
| Preview: | Náhľad normy (PDF) |