EN 13795-2:2004+A1:2009

Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - Part 2: Test methods EN 13795-2:2004+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 EN 13795-2 specifies test methods for evaluating characteristics of surgical drapes, gowns and clean air suits.
NOTE 1 Test methods are specified by referring to a standard test method and, if necessary, specifying amendments to adapt the test method for the purpose of this document.
NOTE 2 EN 13795-2 does not cover a test method for evaluating adhesion for fixation for the purpose of wound isolation as there is no suitable test method for adhesion to human skin available at present. For more information on adhesion for fixation for the purpose of wound isolation see EN 13795-1: 2002, Annex B.

Related legislation

Legislation related to this standard

93/42/EEC

Medical devices

Harmonized/Supporting
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

Life cycle

NOW

WITHDRAWN
EN 13795-2:2004+A1:2009
99.60 Withdrawal effective
Mar 16, 2011

REVISED BY

WITHDRAWN
EN 13795:2011