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ILNAS-EN 455-2:2015 Edition 04/2015
Medical gloves for single use - Part 2: Requirements and testing for physical properties
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Abstract

This European Standard 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 European Standard 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    23/05/2013   date of ratification (dor)    24/01/2015
end of the vote on the project    23/10/2013   date of anouncement (doa)    31/07/2015
start of the vote on the final project    23/10/2014   date of publication (dop)    31/10/2015
end of the vote on the final project    23/12/2014   date of withdrawal (dow)    31/10/2015


Publication Official Journal
of the Grand-Duchy of Luxembourg
16/06/2015
Reference Mémorial A N° 110

Relations

Relations to older standards
ILNAS-EN 455-2:2009+A2:2013
ILNAS-EN 455-2:2009+A1:2011

International Classification for Standards (ICS codes) :

11.140 : Hospital equipment
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