NEN-EN-ISO 11608-5
Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions
inactive
| Organization: | NEN |
| Publication Date: | 1 October 2012 |
| Status: | inactive |
| Page Count: | 30 |
| ICS Code (Syringes, needles and catheters): | 11.040.25 |
scope:
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 medicinal products in humans: - drug product preparation (e.g. reconstitution) - needle preparation - air removal - priming - dose setting - actuation - needle insertion - injection of the medicinal product - needle retraction - disabling the NIS-AUTO - needle shielding or hiding - sharps injury protection - needle removal.
Document History
April 1, 2023
Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions
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...
NEN-EN-ISO 11608-5
October 1, 2012
Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions
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...
November 1, 2010
Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions
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...