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:

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

b) needle preparation;

c) air removal;

d) priming;

e) dose setting;

f) actuation;

g) needle insertion;

h) injection of the medicinal product;

i) disabling the NIS-AUTO;

j) needle retraction;

k) needle shielding;

l) needle hiding;

m) sharps injury protection;

n) needle removal.