EN 13795:2011/prA1

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 EN 13795:2011/prA1

General information

10.99 New project approved   Jan 9, 2013

CEN

CEN/TC 205 Non-active medical devices

European Norm

11.140   Hospital equipment

Related legislation

Legislation related to this standard

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

Life cycle

PREVIOUSLY

WITHDRAWN
EN 13795:2011

NOW

IN_DEVELOPMENT
EN 13795:2011/prA1
10.99 New project approved
Jan 9, 2013