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  • BSI
    BS EN ISO 11608-3:2022 - TC Tracked Changes. Needle-based injection systems for medical use. Requirements and test methods - Containers and integrated fluid paths
    Edition: 2022
    $620.36
    / user per year

Description of BS EN ISO 11608-3:2022 - TC 2022

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.

Standard NumberBS EN ISO 11608-3:2022 - TC
TitleTracked Changes. Needle-based injection systems for medical use. Requirements and test methods - Containers and integrated fluid paths
StatusWithdrawn
Publication Date2022-09-21
DescriptorsDimensions, Containers, Injection guns, Parenteral infusion equipment, Injection instruments, Leak tests, Syringes, Design, Medical equipment, Drug administration, Measuring cylinders, Performance, Performance testing, Medical instruments
ICS11.040.25 Syringes, needles and catheters
CommitteeCH/84
ISBN978 0 539 23880 8
PublisherBSI
Pages92

About BSI

BSI Group, also known as the British Standards Institution is the national standards body of the United Kingdom. BSI produces technical standards on a wide range of products and services and also supplies certification and standards-related services to businesses.
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