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ILNAS-EN ISO 7886-4:2019 Edition 03/2019
Sterile hypodermic syringes for single use - Part 4: Syringes with re-use prevention feature (ISO 7886-4:2018)
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  • 21.2 / copy
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Abstract

This document specifies requirements for sterile single-use hypodermic syringes made of plastic and rubber materials with or without needle, and intended for the aspiration of fluids or for the injection of fluids immediately after filling and of design such that the syringe can be rendered unusable after use. This document is not applicable to syringes made of glass [specified in ISO 595 (withdrawn)], auto-disable syringes for fixed dose immunization (ISO 7886‑3) and syringes designed to be pre-filled. It does not address compatibility with injection fluids. Other standards can be applicable when syringes are used for any other intended purpose than those specified in this document. NOTE Syringes designed to reduce the risk of needle-stick injuries can also comply with this document with regard to their re-use prevention properties, but it is stressed that anti-needle-stick properties of syringes are not in themselves addressed in this document.

Status

Standard - Active

Origin

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

Implementation

start of the vote on the project    26/10/2017   date of ratification (dor)    01/03/2019
end of the vote on the project    12/01/2018   date of anouncement (doa)    30/06/2019
start of the vote on the final project    19/07/2018   date of publication (dop)    30/09/2019
end of the vote on the final project    11/09/2018   date of withdrawal (dow)    30/09/2019


Publication Official Journal
of the Grand-Duchy of Luxembourg
24/04/2019
Reference Mémorial A N° 267

Relations

Relations to older standards
ILNAS-EN ISO 7886-4:2009

Relations to international standards
ISO 7886-4 
ISO 7886-4:2018 

International Classification for Standards (ICS codes) :

11.040.25 : Syringes, needles and catheters

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