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EVS-EN ISO 11608-5:2012

Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions (ISO 11608-5:2012)

General information

Withdrawn from 03.04.2023
Base Documents
ISO 11608-5:2012; EN ISO 11608-5:2012
Directives or regulations
None

Standard history

Status
Date
Type
Name
03.04.2023
Main
06.11.2012
Main
This part of ISO 11608 speciies 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.

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