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SRPS EN 455-2:2011

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

Jan 31, 2011
95.99   Withdrawal of Standard   Feb 28, 2013

General information

95.99     Feb 28, 2013

ISS

Z076

European Norm

11.140  

English  

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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 directives

NOTE: If the word "harmonized" (marked in green) is not found in the field with the name of the directive, it means that the European standard is not cited in the OJEU.

93/42/EEC

Medical devices

Harmonized
Directive 93/42/EEC
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

Directive 2007/47/EC

Life cycle

NOW

WITHDRAWN
SRPS EN 455-2:2011
95.99 Withdrawal of Standard
Feb 28, 2013

REVISED BY

WITHDRAWN
SRPS EN 455-2:2013

Related project

Adopted from EN 455-2:2009