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EVS-EN 455-2:2024

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

General information

Valid from 15.05.2024
Base Documents
EN 455-2:2024
Directives or regulations
2017/745 Medical devices (MDR)

Standard history

Status
Date
Type
Name
15.05.2024
Main
08.06.2015
Main
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.

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