Hlavní stránka>BS EN ISO 11608-3:2022 Needle-based injection systems for medical use. Requirements and test methods Containers and integrated fluid paths
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sklademVydáno: 2023-11-13
BS EN ISO 11608-3:2022
Needle-based injection systems for medical use. Requirements and test methods Containers and integrated fluid paths
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This standard BS EN ISO 11608-3:2022 Needle-based injection systems for medical use. Requirements and test methods is classified in these ICS categories:
11.040.25 Syringes, needles and catheters
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.