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ILNAS-EN 455-4:2009 Edition 07/2009
Medical gloves for single use - Part 4: Requirements and testing for shelf life determination
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Abstract

for labelling and the disclosure of information relevant to the test methods used. This European Standard applies to existing, new and significantly changed designs. Existing designs that do not currently have ageing data available should generate that data within a reasonable period of time. 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

Directives

93/42/EEC : Medical devices

Implementation

start of the vote on the project    15/03/2007   date of ratification (dor)    20/06/2009
end of the vote on the project    15/08/2007   date of anouncement (doa)    31/10/2009
start of the vote on the final project    19/03/2009   date of publication (dop)    31/01/2010
end of the vote on the final project    19/05/2009   date of withdrawal (dow)    31/01/2010


Publication Official Journal
of the Grand-Duchy of Luxembourg
14/03/2011
Reference Mémorial A N° 47

International Classification for Standards (ICS codes) :

11.140 : Hospital equipment

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