EN 455-2:2015

Medical gloves for single use - Part 2: Requirements and testing for physical properties EN 455-2:2015

Publication date:   Jul 16, 2015

General information

90.93 Standard confirmed   Mar 18, 2021

CEN

CEN/TC 205 Non-active medical devices

European Norm

11.140   Hospital equipment

Buying

Published

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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 European 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

Life cycle

PREVIOUSLY

WITHDRAWN
EN 455-2:2009+A2:2013

NOW

PUBLISHED
EN 455-2:2015
90.93 Standard confirmed
Mar 18, 2021

REVISED BY

IN_DEVELOPMENT
EN 455-2:2024