BS EN ISO 11608-5:2023 PDF

Scope: 1 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)...

BS EN ISO 11608-5:2023 Referenced Document

ISO 11608-1:2022 Needle-based injection systems for medical use — Requirements and test methods — Part 1: Needle-based injection systems
ISO 11608-3:2022 Needle-based injection systems for medical use — Requirements and test methods — Part 3: Containers and integrated fluid paths
ISO 23908:2011 Sharps injury protection - Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling

2023 BS EN ISO 11608-5:2023 Needle-based injection systems for medical use. Requirements and test methods - Automated functions
2012 BS EN ISO 11608-5:2012 Needle-based injection systems for medical use. Requirements and test methods. Automated functions