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ČSN EN ISO 11608-3 (855930)
Needle-based injection systems for medical use - Requirements and test methods - Part 3: Containers and integrated fluid paths
Translate name
STANDARD published on 1.11.2022
The information about the standard:
Designation standards: ČSN EN ISO 11608-3
Classification mark: 855930
Catalog number: 515380
Publication date standards: 1.11.2022
SKU: NS-1088344
The number of pages: 40
Approximate weight : 120 g (0.26 lbs)
Country: Czech technical standard
Category: Technical standards ČSN
The category - similar standards:
Annotation of standard text ČSN EN ISO 11608-3 (855930):
This document specifies requirements and test methods for design verification of containers and integrated fluid paths used with Needle-Based Injection Systems (NISs) according to ISO 11608-1. It is applicable to single and multi-dose containers either filled by the manufacturer (primary container closure) or by the end-user (reservoir) (e.g. cartridges, syringes) and fluid paths that are integrated with the NIS at the point of manufacture. This document is also applicable to prefilled syringes (see ISO 11040-8) when used with a NIS (see also scope of ISO 11608-1:2022). This document is not applicable to the following products: - sterile hypodermic needles; - sterile hypodermic syringes; - sterile single-use syringes, with or without needle, for insulin; - containers that can be refilled multiple times; - containers intended for dental use; - catheters or infusion sets that are attached or assembled separately by the user
Preview of the standard ČSN EN ISO 11608-3 (855930)
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