prBAS EN 455-3:2025
Medical gloves for single use - Part 3: Requirements and testing for biological evaluation
General information
Status:Project
Number of pages:43
Adoption method:Proglašavanje
Language:engleski
Edition:4.
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 part of EN 455 specifies requirements for the evaluation of biological safety for medical gloves for single use. It gives requirements for labelling and the disclosure of information relevant to the test methods used.
Lifecycle
...
Original document and degree of correspondence
EN 455-3:2023, identical
Relation to BAS standards
Work material
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