scope:

This document specifies requirements and test methods for automated functions in needle-based injection systems with automated functions (NIS-AUTO).

General requirements are provided for all automated functions. In addition, specific requirements are provided for the following automated functions:

a) medicinal product preparation (e.g. reconstitution);

b) needle preparation;

c) needle hiding;

d) priming;

e) dose setting;

f) needle insertion;

g) injection depth control;

h) injection of the medicinal product;

i) recording of device functions;

NOTE This document does not cover remote communication from the NIS-AUTO (pertains to wired and wireless communication transfer from the NIS auto).

j) disabling the NIS-AUTO;

k) needle retraction;

l) needle shielding;

m) needle removal.

All references to "function" in this document are by definition construed as automated functions (see 3.2). This document does not apply to functions that are performed manually by the user.