BS EN ISO 11608-5:2012

Needle-based injection systems for medical use. Requirements and test methods. Automated functions | Status: Superseded, Withdrawn

1 Scope 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:

1. a) drug product preparation (e.g. reconstitution);
2. b) needle preparation;
3. c) air removal;
4. d) priming;
5. e) dose setting;
6. f) actuation;
7. g) needle insertion;
8. h) injection of the medicinal product;
9. i) disabling the NIS-AUTO;
10. j) needle retraction;
11. k) needle shielding;
12. l) needle hiding;
13. m) sharps injury protection;
14. n) needle removal.