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99.60 Withdrawal effective Feb 16, 2011
CEN
CEN/TC 205 Non-active medical devices
European Norm
11.140 Hospital equipment
Withdrawn
This European Standard specifies requirements and gives test methods for physical properties of single-use medical gloves (i.e. surgical gloves and examination/procedure gloves) in order to ensure that they provide and maintain in use an adequate level of protection from cross contamination for both patient and user.
This 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.
Legislation related to this standard
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
WITHDRAWN
EN 455-2:2000
WITHDRAWN
EN 455-2:2009
99.60
Withdrawal effective
Feb 16, 2011
IN_DEVELOPMENT
EN 455-2:2009/FprA1