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
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Status: WithdrawnPublication date: 2012-10Stage: Withdrawal of International Standard [95.99]
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Edition: 2Number of pages: 10
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Technical Committee :Ïã¸ÛÁùºÏ²Ê¿ª½±/TC 84ICS :11.040.25
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Life cycle
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Previously
WithdrawnÏã¸ÛÁùºÏ²Ê¿ª½± 11608-3:2000
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Now
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Revised by
PublishedÏã¸ÛÁùºÏ²Ê¿ª½± 11608-3:2022
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