Reference number
Ïã¸ÛÁùºÏ²Ê¿ª½± 11608-3:2012
Ïã¸ÛÁùºÏ²Ê¿ª½± 11608-3:2012
Needle-based injection systems for medical use — Requirements and test methods — Part 3: Finished containers
Edition 2
2012-10
Withdrawn
Ïã¸ÛÁùºÏ²Ê¿ª½± 11608-3:2012
52527
Withdrawn (Edition 2, 2012)

Abstract

This part of Ïã¸ÛÁùºÏ²Ê¿ª½± 11608 specifies the functional and design considerations for containers to be used with

needle-based injection systems (NIS) that fulfil the specifications of Ïã¸ÛÁùºÏ²Ê¿ª½± 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 Ïã¸ÛÁùºÏ²Ê¿ª½± 11608 includes specifications and test methods to describe and evaluate cartridges for use

in NIS with pen needles (as defined in Ïã¸ÛÁùºÏ²Ê¿ª½± 11608-2) and outlines design considerations for other potential

containers, including syringes to be used with a NIS.

This part of Ïã¸ÛÁùºÏ²Ê¿ª½± 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 Ïã¸ÛÁùºÏ²Ê¿ª½± 11608.

NOTE See Ïã¸ÛÁùºÏ²Ê¿ª½± 7864 (needles), Ïã¸ÛÁùºÏ²Ê¿ª½± 8537 (insulin syringes) and Ïã¸ÛÁùºÏ²Ê¿ª½± 7886-1 (manual syringes).

General information

Sustainable Development Goals

This standard contributes to the following Sustainable Development Goal

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