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ILNAS-EN 13795:2011 Edition 03/2011
Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - General requirements for manufacturers, processors and products, test methods, performance requirements and performance levels
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Status

Standard - Withdrawn

Origin

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

Directives

93/42/EEC : Medical devices
2007/47/EC : Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market

Implementation

start of the vote on the project    08/10/2009   date of ratification (dor)    05/02/2011
end of the vote on the project    08/03/2010   date of anouncement (doa)    30/06/2011
start of the vote on the final project    04/11/2010   date of publication (dop)    30/09/2011
end of the vote on the final project    04/01/2011   date of withdrawal (dow)    30/09/2011


Publication Official Journal
of the Grand-Duchy of Luxembourg
05/01/2012
Reference

Relations

Evolutions
ILNAS-EN 13795:2011+A1:2013
ILNAS-EN 13795-1:2019
ILNAS-EN 13795-2:2019
ILNAS-EN 13795:2011+A1:2013

Relations to older standards
ILNAS-EN 13795-3:2006+A1:2009
ILNAS-EN 13795-2:2004+A1:2009
ILNAS-EN 13795-1:2002+A1:2009
ILNAS-EN 13795-3:2006
ILNAS-EN 13795-2:2004
ILNAS-EN 13795-1:2002

International Classification for Standards (ICS codes) :

11.140 : Hospital equipment

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