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Glavni meni

ISO 11608-5:2022

Needle-based injection systems for medical use — Requirements and test methods — Part 5: Automated functions
7. 4. 2022.

Опште информације

60.60     7. 4. 2022.

ISO

ISO/TC 84

Međunarodni standard

11.040.25  

engleski   francuski  

Kupovina

Objavljen

Jezik na kome želite da primite dokument.

Apstrakt

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.

Životni ciklus

PRETHODNO

POVUČEN
ISO 11608-5:2012

TRENUTNO

OBJAVLJEN
ISO 11608-5:2022
60.60 Standard objavljen
7. 4. 2022.

Nacionalna preuzimanja

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