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Homepage>BS Standards>11 HEALTH CARE TECHNOLOGY>11.040 Medical equipment>11.040.25 Syringes, needles and catheters>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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immediate downloadReleased: 2022-07-19
BS EN ISO 11608-3:2022 Needle-based injection systems for medical use. Requirements and test methods Containers and integrated fluid paths

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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Standard number:BS EN ISO 11608-3:2022
Pages:40
Released:2022-07-19
ISBN:978 0 539 02120 2
Status:Standard
DESCRIPTION

BS EN ISO 11608-3:2022


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.