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ČSN EN ISO 11608-1 (855930)
Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems
Automatically translated name:
Needle injection systems for medical use - Requirements and test methods - Part 1 : Needle injection systems ( standard for direct use as CSN ).
STANDARD published on 1.7.2015
The information about the standard:
Designation standards: ČSN EN ISO 11608-1
Classification mark: 855930
Catalog number: 97309
Publication date standards: 1.7.2015
SKU: NS-609509
The number of pages: 60
Approximate weight : 180 g (0.40 lbs)
Country: Czech technical standard
Category: Technical standards ČSN
The category - similar standards:
Annotation of standard text ČSN EN ISO 11608-1 (855930):
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
These changes apply to this standard:
ČSN EN ISO 11608-1:2015/Z1 (855930)
Change
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Jehlové injekční systémy pro lékařské účely - Požadavky a metody zkoušení - Část 1: Jehlové injekční systémy (Norma k přímému použití jako ČSN).
Change published on 1.11.2022
Selected format: English - Print design (1.20 USD)
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Preview of the standard ČSN EN ISO 11608-1 (855930)
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