STN EN ISO 11608-4
| Name: | STN EN ISO 11608-4 |
| Validity: | Valid |
| Number of pages: | 76 |
| Language: |
EN
|
| Paper: | 28,80€ |
| Electronic version |
a) Only read (without ability to print and copy)
25,92€ b) Without ability to print, with ability to copy (printscreen) 28,80€ c) With ability to print and copy (printscreen) 37,44€ |
| Slovak title | 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) |
| English title | Needle-based injection systems for medical use - Requirements and test methods - Part 4: Needle-based injection systems containing electronics (ISO 11608-4:2022) |
| Release Date: | 01. 08. 2022 |
| Date of withdrawal: | 01. 04. 2025 |
| ICS: | 11.040.25 |
| Sorting character/National clasification code | 85 5930 |
| Level of incorporation: | idt EN ISO 11608-4:2022, idt ISO 11608-4:2022 |
| Official Journal | 07/22 |
| Amendments | |
| Replaced by: | STN EN ISO 11608-4:2025-04 (85 5930) |
| Repleces: | STN EN ISO 11608-4:2008-02 (85 5930) |
| Note in Official Journal: | |
| Subject of the standard: | 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. |
| Preview: | Náhľad normy (PDF) |