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ILNAS-EN ISO 7886-3:2020 Edition 05/2020
Sterile hypodermic syringes for single use - Part 3: Auto-disabled syringes for fixed-dose immunization (ISO 7886-3:2020)
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Abstract

This document specifies the properties and performance of sterile single-use hypodermic syringes with an auto-disable syringe feature intended to deliver a fixed dose of vaccine immediately after filling. The syringes can be made of plastic, rubber or other materials and can be with or without needle and needle protection feature. This document does not specify the design of the auto-disable syringe feature. This document is not applicable to syringes for use with insulin (covered by ISO 8537), syringes for use with power-driven syringe pumps (covered by ISO 7886-2), reuse prevention syringes (covered by ISO 7886-4) or syringes designed to be prefilled (covered by the ISO 11040 series). It does not address compatibility with injection fluids/vaccines.

Status

Standard - Active

Origin

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

Implementation

start of the vote on the project    16/05/2019   date of ratification (dor)    24/04/2020
end of the vote on the project    09/08/2019   date of anouncement (doa)    31/08/2020
start of the vote on the final project    30/01/2020   date of publication (dop)    30/11/2020
end of the vote on the final project    23/03/2020   date of withdrawal (dow)    30/11/2020


Publication Official Journal
of the Grand-Duchy of Luxembourg
16/11/2020
Reference Mémorial A N° 903

Relations

Relations to older standards
ILNAS-EN ISO 7886-3:2009

Relations to international standards
ISO 7886-3 
ISO 7886-3:2020 

International Classification for Standards (ICS codes) :

11.040.25 : Syringes, needles and catheters

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