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ILNAS-EN ISO 11608-3:2022 Edition 05/2022
Needle-based injection systems for medical use - Requirements and test methods - Part 3: Containers and integrated fluid paths (ISO 11608-3:2022)
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Abstract

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.

Status

Standard - Active

Origin

Technical Committee :
CEN/TC 205 : Non-active medical devices

Implementation

start of the vote on the project    20/02/2020   date of ratification (dor)    02/01/2022
end of the vote on the project    12/05/2020   date of anouncement (doa)    31/08/2022
start of the vote on the final project    07/10/2021   date of publication (dop)    30/11/2022
end of the vote on the final project    01/12/2021   date of withdrawal (dow)    30/11/2022


Publication Official Journal
of the Grand-Duchy of Luxembourg
Reference

Relations

Relations to older standards
ILNAS-EN ISO 11608-3:2012

Relations to international standards
ISO 11608-3:2022 
ISO 11608-3 

International Classification for Standards (ICS codes) :

11.040.25 : Syringes, needles and catheters

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