ISO 11608-3:2012
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
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Needle-based injection systems for medical use — Requirements and test methods — Part 3: Finished containers
Hardcopy , PDF 1 User , PDF 3 Users , PDF 5 Users , PDF 9 Users
English, French
20-09-2012
09-04-2025
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).
| Committee |
ISO/TC 84
|
| DevelopmentNote |
Supersedes ISO/DIS 11608-3. (09/2012)
|
| DocumentType |
Standard
|
| Pages |
10
|
| PublisherName |
International Organization for Standardization
|
| Status |
Withdrawn
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| DIN EN ISO 11608-3:2013-01 | Identical |
| NF EN ISO 11608-3 : 2012 | Identical |
| NBN EN ISO 11608-3 : 2012 | Identical |
| NEN EN ISO 11608-3 : 2012 | Identical |
| NS EN ISO 11608-3 : 2012 | Identical |
| I.S. EN ISO 11608-3:2012 | Identical |
| PN EN ISO 11608-3 : 2013 | Identical |
| BS EN ISO 11608-3:2012 | Identical |
| EN ISO 11608-3:2012 | Identical |
| UNE-EN ISO 11608-3:2013 | Identical |
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