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EN 455-3:2023

Medical gloves for single use - Part 3: Requirements and testing for biological evaluation

Publication date:   Feb 19, 2024

General information

60.60 Standard published   Nov 29, 2023

CEN

CEN/TC 205 Non-active medical devices

European Norm

11.140   Hospital equipment

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Scope

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.

Related legislation

Legislation related to this standard

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/Supporting
Legislation 2017/745

Life cycle

PREVIOUSLY

WITHDRAWN
EN 455-3:2015

NOW

PUBLISHED
EN 455-3:2023
60.60 Standard published
Nov 29, 2023

CORRIGENDA / AMENDMENTS

IN_DEVELOPMENT
EN 455-3:2023/prA1