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EN ISO 11608-5:2023

Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions (ISO 11608-5:2022)

Publication date:   Jul 17, 2023

General information

60.60 Standard published   Mar 22, 2023

CEN

CEN/TC 205 Non-active medical devices

European Norm

11.040.25   Syringes, needles and catheters

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Scope

This part of ISO 11608 specifies requirements and test methods for needle-based injection systems with automated functions (referred to in the standard as NIS-AUTO), for the administration of medicinal products in humans. This document does not cover remote communication from the NIS-AUTO.

Life cycle

PREVIOUSLY

WITHDRAWN
EN ISO 11608-5:2012

NOW

PUBLISHED
EN ISO 11608-5:2023
60.60 Standard published
Mar 22, 2023

Relations

Adopted from ISO 11608-5:2022 IDENTICAL