DSF/prEN ISO 11608-3
Needle-based injection systems for medical use - Requirements and test methods - Part 3: Finished containers (ISO/DIS 11608-3:2010)
| Organization: | DS |
| Status: | inactive |
| Page Count: | 20 |
| ICS Code (Transfusion, infusion and injection equipment): | 11.040.20 |
| ICS Code (Syringes, needles and catheters): | 11.040.25 |
scope:
This part of ISO 11608 specifies the functional and design considerations for containers to be used with Needle-based Injection Systems (NIS) which fulfil the specifications of ISO 11608-1. Containers covered in this standard include single and multi-dose containers (either filled by the manufacturer or by the end-user) which can be provided to the end user integrated in the NIS or assembled with the NIS at the time of use. The standard includes specifications and standardized test methods to describe and evaluate cartridges for use in NIS with pen needles (defined in ISO 11608-2) and outlines design considerations for other potential containers, including syringes when they are intended to be used with the NIS. Syringes and needles that are sold separately and not intended for use in a NIS are excluded from this standard, as they are covered by other standards (e.g. ISO 7864 (needles), ISO 8537 (insulin syringes), ISO 7886 (manual syringes). Cartridge-based containers described herein are used with needles described in ISO 11608-2. This part of ISO 11608 is not applicable to cartridges intended for dental use.
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