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EN ISO 11608-1:2015

Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems (ISO 11608-1:2014) EN ISO 11608-1:2015

Publication date:   Apr 21, 2015

General information

99.60 Withdrawal effective   May 4, 2022

CEN

CEN/TC 205 Non-active medical devices

European Norm

11.040.25   Syringes, needles and catheters

Buying

Published

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Scope

ISO 11608-1:2014 specifies requirements and test methods for needle-based injection systems (NISs) intended to be used with needles and with replaceable or non-replaceable containers. Containers covered in ISO 11608-1:2014 include single- and multi-dose syringe-based and cartridge-based systems, filled either by the manufacturer or by the end-user.

Related legislation

Legislation related to this standard

93/42/EEC

Medical devices

Legislation 93/42/EEC

Life cycle

PREVIOUSLY

WITHDRAWN
EN ISO 11608-1:2012

NOW

WITHDRAWN
EN ISO 11608-1:2015
99.60 Withdrawal effective
May 4, 2022

REVISED BY

PUBLISHED
EN ISO 11608-1:2022