NEN-EN-ISO 11608-1
Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems
inactive
| Organization: | NEN |
| Publication Date: | 1 April 2012 |
| Status: | inactive |
| Page Count: | 56 |
| 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 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
June 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...
January 1, 2015
Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems
NEN-EN-ISO 11608-1 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...
NEN-EN-ISO 11608-1
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....
November 1, 2010
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....
February 1, 2001
Pen-injectors for medical use - Part 1: Pen-injectors - Requirements and test methods
Specifies requirements and test methods for pen-injectors to be used with needles and with replaceable or non-replaceable prefilled cartridges. Pen-injectors which are not electrically driven, but...
January 1, 1999
Pen injectors for medical use - Part 1: Requirements and test methods
Specifies requirements and test methods for pen-injectors to be used with needles and with replaceable or non-replaceable prefilled cartridges. Pen-injectors which are not electrically driven, but...