DSF/prEN ISO 11608-1
Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems (ISO/DIS 11608-1:2010)
inactive
| Organization: | DS |
| Status: | inactive |
| Page Count: | 48 |
| 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 NISs intended to be used with needles and with replaceable or non-replaceable containers. Containers covered in this standard include single and multi-dose syringe-based and cartridge-based systems; either filled by the manufacturer or by the end-user. NISs which are equipped with electronic or electromechanical components are covered by this standard as referenced by ISO 11608-4. NISs which are equipped with automated functions are also covered by this standard, as referenced by ISO 11608-5. Needle-free injectors are not covered by this standard. Requirements for methods and/or equipment associated with end-user filling of containers are not covered by this standard.
Document History
May 9, 2022
Needle-based injection systems for medical use – Requirements and test methods – Part 1: Needle-based injection systems (ISO 11608-1:2022)
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...
February 2, 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....
May 15, 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....
March 21, 2001
Pen-injectors for medical use - Part 1: Pen-injectors - Requirements and test methods
This part of the standard specifies requirements and test methods for pen-injectors intended to be used with needles and with replaceable or non-replaceable prefilled cartridges. This part is also...
Needle-based injection systems for medical use – Requirements and test methods – Part 1: Needle-based injection systems (ISO/DIS 11608-1:2020)
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, through...
Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems (ISO/FDIS 11608-1:2012)
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....
DSF/prEN ISO 11608-1
Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems (ISO/DIS 11608-1:2010)
This part of ISO 11608 specifies requirements and test methods for NISs intended to be used with needles and with replaceable or non-replaceable containers. Containers covered in this standard...
Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems (ISO/FDIS 11608-1:2014)
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....