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SRPS EN 455-2:2024

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

Jul 31, 2024

General information

60.60     Jul 31, 2024

ISS

Z076

European Norm

11.140  

English  

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Scope

This document 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 document 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.

2017/745

Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC

Harmonized

Life cycle

PREVIOUSLY

WITHDRAWN
SRPS EN 455-2:2015

NOW

PUBLISHED
SRPS EN 455-2:2024
60.60 Standard published
Jul 31, 2024

Related project

Adopted from EN 455-2:2024 IDENTICAL