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ILNAS-EN 455-2:2024 Edition 05/2024
Medical gloves for single use - Part 2: Requirements and testing for physical properties
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Abstract

This document specifies requirements and gives test methods for physical properties of single-use medical gloves (i.e. surgical gloves and examination/procedure gloves) in order to ensure that they provide and maintain in use an adequate level of protection from cross contamination for both patient and user. This document does not specify the size of a lot. Attention is drawn to the difficulties that can be associated with the distribution and control of very large lots. The recommended maximum individual lot size for production is 500 000.

Status

Standard - Active

Origin

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

Implementation

start of the vote on the project    12/01/2023   date of ratification (dor)    15/04/2024
end of the vote on the project    06/04/2023   date of anouncement (doa)    31/08/2024
start of the vote on the final project    18/01/2024   date of publication (dop)    30/11/2024
end of the vote on the final project    14/03/2024   date of withdrawal (dow)    30/11/2024


Publication Official Journal
of the Grand-Duchy of Luxembourg
Reference

Relations

Relations to older standards
ILNAS-EN 455-2:2015

International Classification for Standards (ICS codes) :

11.140 : Hospital equipment

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