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SSH EN ISO 11608-1:2022

Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems (ISO 11608-1:2022)

Sep 29, 2023

General information

60.60     Sep 29, 2023

DPS

DPS/KT 205

European Norm

11.040.25  

English  

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Scope

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.

Life cycle

PREVIOUSLY

WITHDRAWN
SSH EN ISO 11608-1:2015

NOW

PUBLISHED
SSH EN ISO 11608-1:2022
60.60 Standard published
Sep 29, 2023

Related project

Adopted from EN ISO 11608-1:2022 IDENTICAL