DSF/FprEN ISO 11608-5
Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions (ISO/FDIS 11608-5:2012)
inactive
| Organization: | DS |
| Status: | inactive |
| Page Count: | 28 |
| ICS Code (Transfusion, infusion and injection equipment): | 11.040.20 |
| ICS Code (Syringes, needles and catheters): | 11.040.25 |
scope:
This part of ISO 11608 specifies 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.
Document History
March 27, 2023
Needle-based injection systems for medical use – Requirements and test methods – Part 5: Automated functions (ISO 11608-5:2022)
This part of ISO 11608 specifies requirements and test methods for needle-based injection systems with automated functions (referred to in the standard as NIS-AUTO), for the administration of...
November 26, 2012
Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions
ISO 11608-5:2012 specifies requirements and test methods for the automated functions of needle-based injection systems with automated functions (NIS-AUTO), for the administration of medicinal...
Needle-based injection systems for medical use – Requirements and test methods – Part 5: Automated functions (ISO/DIS 11608-5:2020)
This document specifies requirements and test methods for needle-based injection systems with automated functions (NIS-AUTO), including but not limited to: a) medicinal product preparation (e.g....
DSF/FprEN ISO 11608-5
Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions (ISO/FDIS 11608-5:2012)
This part of ISO 11608 specifies requirements and test methods for the automated functions of needle-based injection systems with automated functions (NIS-AUTO), for the administration of medicinal...
Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions (ISO/DIS 11608-5:2010)
This standard specifies requirements and test methods for the following needle-based injection systems with automated functions (referred to in the standard as NIS-AUTO), for the administration of...