EN 455-2:2009+A2:2013

Medical gloves for single use - Part 2: Requirements and testing for physical properties

Publication date:   Mar 19, 2013

General information

99.60 Withdrawal effective   Apr 29, 2015

CEN

CEN/TC 205 Non-active medical devices

European Norm

11.140   Hospital equipment

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Scope

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.

Related legislation

Legislation related to this standard

93/42/EEC

Medical devices

Harmonized/Supporting

Life cycle

NOW

WITHDRAWN
EN 455-2:2009+A2:2013
99.60 Withdrawal effective
Apr 29, 2015

REVISED BY

WITHDRAWN
EN 455-2:2015