Objavljen
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.
POVUČEN
ISO 11608-5:2012
OBJAVLJEN
ISO 11608-5:2022
60.60
Standard objavljen
7. 4. 2022.
Injekcioni sistemi sa iglom za medicinsku upotrebu – Zahtevi i metode ispitivanja – Deo 5: Automatizovane funkcije
60.60 Standard objavljen
Injekcioni sistemi sa iglom za medicinsku upotrebu — Zahtevi i metode ispitivanja — Deo 5: Automatizovane funkcije
50.98 Projekat se briše iz plana rada komisije za standarde