NEN-EN-ISO 11608-4
Pen-injectors for medical use - Part 4: Requirements and test methods for electronic and electromechanical pen-injectors
inactive
| Organization: | NEN |
| Publication Date: | 1 February 2008 |
| Status: | inactive |
| Page Count: | 25 |
| ICS Code (Syringes, needles and catheters): | 11.040.25 |
scope:
This part of ISO 11608 specifies requirements and test methods for electromechanically driven injectors intended to be used with needles and with replaceable or non-replaceable cartridges. The injector may be for single-use or multiple-use. The injector system is intended to deliver medication to an end-user by self-administration or with assistance. This part of ISO 11608 is neither applicable for needle-free injectors (as covered in ISO 21649) nor infusion pumps (as covered in IEC 60601-2-24). This part of ISO 11608 is not applicable for devices that are capable of operating while connected to an external power supply.
Document History
June 1, 2022
Needle-based injection systems for medical use - Requirements and test methods - Part 4: Needle-based injection systems containing electronics
This document specifies requirements and test methods for needle-based injection systems (NISs) containing electronics with or without software (NIS-Es).
The needle-based injection system containing...
NEN-EN-ISO 11608-4
February 1, 2008
Pen-injectors for medical use - Part 4: Requirements and test methods for electronic and electromechanical pen-injectors
This part of ISO 11608 specifies requirements and test methods for electromechanically driven injectors intended to be used with needles and with replaceable or non-replaceable cartridges. The...