M00017643
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ISO FDIS 11608-5 2012 Edition, June 28, 2012 NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 5: AUTOMATED FUNCTIONS
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Availability date: 07/14/2021
Description / Abstract:
This part of ISO 11608 specifies requirements and test methods
for the automated functions of needle-based injection systems with
automated functions (NISAUTO), 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 NISAUTO;
j) needle retraction;
k) needle shielding;
l) needle hiding;
m) sharps injury protection;
n) needle removal.