ISO 11608-3:2012

Needle-based injection systems for medical use — Requirements and test methods — Part 3: Finished containers

Publication date:   Sep 20, 2012

95.99 Withdrawal of Standard   Apr 7, 2022

General information

95.99 Withdrawal of Standard   Apr 7, 2022

ISO

ISO/TC 84 Devices for administration of medicinal products and catheters

International Standard

11.040.25   Syringes, needles and catheters

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Scope

This part of ISO 11608 specifies the functional and design considerations for containers to be used with
needle-based injection systems (NIS) that fulfil the specifications of ISO 11608-1. It is applicable to single and
multi-dose containers (either filled by the manufacturer or by the end-user) which can be provided to the enduser
integrated in the NIS or assembled with the NIS at the time of use.
This part of ISO 11608 includes specifications and test methods to describe and evaluate cartridges for use
in NIS with pen needles (as defined in ISO 11608-2) and outlines design considerations for other potential
containers, including syringes to be used with a NIS.
This part of ISO 11608 is not applicable to cartridges intended for dental use.
Syringes and needles that are sold separately and not intended for use in a NIS are outside the scope of this
part of ISO 11608.
NOTE See ISO 7864 (needles), ISO 8537 (insulin syringes) and ISO 7886-1 (manual syringes).

Life cycle

PREVIOUSLY

WITHDRAWN
ISO 11608-3:2000

NOW

WITHDRAWN
ISO 11608-3:2012
95.99 Withdrawal of Standard
Apr 7, 2022

REVISED BY

PUBLISHED
ISO 11608-3:2022