ISO 11608-5:2022

Needle-based injection systems for medical use — Requirements and test methods — Part 5: Automated functions

Publication date:   Apr 7, 2022

General information

60.60 Standard published   Apr 7, 2022

ISO

ISO/TC 84 Devices for administration of medicinal products and catheters

International Standard

11.040.25   Syringes, needles and catheters

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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.

Life cycle

PREVIOUSLY

WITHDRAWN
ISO 11608-5:2012

NOW

PUBLISHED
ISO 11608-5:2022
60.60 Standard published
Apr 7, 2022