prBAS EN 455-2:2025
Medical gloves for single use - Part 2: Requirements and testing for physical properties
General information
Status:Project
Number of pages:14
Adoption method:Proglašavanje
Language:engleski
Edition:2.
Realization date:22.10.2024
Forseen date for next stage code:12.03.2025
Technical committee:BAS/TC 25, Healthcare
Directives:
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
ICS:
11.140, Hospital equipment
Abstract
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.
Lifecycle
...
Original document and degree of correspondence
EN 455-2:2024, identical
Relation to BAS standards
Work material
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