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immediate downloadReleased: 2012-10-31
BS EN ISO 11608-5:2012
Needle-based injection systems for medical use. Requirements and test methods Automated functions
CURRENCY
| Standard number: | BS EN ISO 11608-5:2012 |
| Pages: | 26 |
| Released: | 2012-10-31 |
| ISBN: | 978 0 580 69949 8 |
| Status: | Standard |
DESCRIPTION
BS EN ISO 11608-5:2012
This standard BS EN ISO 11608-5:2012 Needle-based injection systems for medical use. Requirements and test methods is classified in these ICS categories:
- 11.040.25 Syringes, needles and catheters
This part of ISO 11608 specifies requirements and test methods for the automated functions of needle-based injection systems with automated functions (NIS-AUTO), for the administration of medicinal products in humans, including but not limited to:
drug product preparation (e.g. reconstitution);
needle preparation;
air removal;
priming;
dose setting;
actuation;
needle insertion;
injection of the medicinal product;
disabling the NIS-AUTO;
needle retraction;
needle shielding;
needle hiding;
sharps injury protection;
needle removal.
