EN ISO 11608-1:2022/A1:2026
Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems - Amendment 1 (ISO 11608-1:2022/Amd1:2026)
Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems - Amendment 1 (ISO 11608-1:2022/Amd1:2026)
- Статус документа:
- Действующий
- Формат:
- Электронный (PDF)
- Количество страниц:
- 9
- Дата публикации:
- 6 мая 2026 г.
- Издание:
- CEN EN 11608 edition 1 version 1
- ICS:
- 11.040.25
Abstract
Overview
EN ISO 11608-1:2022/A1:2026 is the latest amendment to the standard for needle-based injection systems (NIS) for medical use, specifically focusing on part 1: requirements and test methods. Published by CEN and developed through collaboration with ISO and technical committee ISO/TC 84, this amendment enhances the clarity and consistency of terminology and updates procedural details related to the testing and evaluation of injection systems. The amendment ensures alignment and precision across documentation, improving how manufacturers and stakeholders approach terminology, inspection, and performance verification for medical injection devices.
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