DS/EN ISO 11608-1
Needle-based injection systems for medical use – Requirements and test methods – Part 1: Needle-based injection systems
active, Most Current
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| Organization: | DS |
| Publication Date: | 2 February 2015 |
| Status: | active |
| Page Count: | 56 |
| 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 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...
DS/EN ISO 11608-1
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....
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....