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EN 13795-3:2006+A1:2009

Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - Part 3: Performance requirements and performance levels EN 13795-3:2006+A1:2009

Publication date:   Aug 20, 2010

General information

99.60 Withdrawal effective   Mar 16, 2011

CEN

CEN/TC 205 Non-active medical devices

European Norm

11.140   Hospital equipment

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Scope

This part of the series of EN 13795 specifies performance requirements for surgical drapes, gowns and clean air suits.
NOTE General performance requirements are specified for various characteristics as per EN 13795-1:2002 Tables 1, 2 and 3 and should be evaluated according to EN 13795-2, EN ISO 22610 and EN ISO 22612.

Related legislation

Legislation related to this standard

93/42/EEC

Medical devices

Harmonized/Supporting
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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

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Life cycle

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WITHDRAWN
EN 13795-3:2006+A1:2009
99.60 Withdrawal effective
Mar 16, 2011

REVISED BY

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EN 13795:2011