Needle-based injection systems for medical use - Requirements and test methods - Part 3: Containers and integrated fluid paths
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English Hardcopy
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Number of Standard:
CSN EN ISO 11608-3
Category:
855930
Pages:
40
Released:
01.11.2022
Catalog number:
515380
DESCRIPTION
CSN EN ISO 11608-3
CSN EN ISO 11608-3 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. Original English text of CSN EN Standard. The price of the Standard included all amendments and correcturs.