CEN - EN ISO 11608-1
Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems
inactive
| Organization: | CEN |
| Publication Date: | 1 January 2015 |
| Status: | inactive |
| Page Count: | 54 |
| ICS Code (Syringes, needles and catheters): | 11.040.25 |
scope:
This part of ISO 11608 specifies requirements and test methods for needle-based injection systems (NISs) intended to be used with needles and with replaceable or non-replaceable containers. Containers covered in this part of ISO 11608 include single- and multi-dose syringe-based and cartridge-based systems, filled either by the manufacturer or by the end-user.
Additional guidance for NISs equipped with electronic or electromechanical components and NISs equipped with automated functions is given in ISO 11608-4 and ISO 11608-5 respectively.
Needle-free injectors, and requirements relating to methods or equipment associated with end-user filling of containers, are outside the scope of this part of ISO 11608.
Document History
May 1, 2022
Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems
This document specifies requirements and test methods for Needle-Based Injection Systems (NISs) for single-patient use intended to deliver discrete volumes (bolus) of medicinal product, which can be...
EN ISO 11608-1
January 1, 2015
Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems
This part of ISO 11608 specifies requirements and test methods for needle-based injection systems (NISs) intended to be used with needles and with replaceable or non-replaceable containers....
April 1, 2012
Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems
This part of ISO 11608 specifies requirements and test methods for needle-based injection systems (NISs) intended to be used with needles and with replaceable or non-replaceable containers....
December 1, 2000
Pen-Injectors for Medical Use - Part 1: Pen-Injectors - Requirements and Test Methods
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