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EN 455-3:2023/prA1

Medical gloves for single use - Part 3: Requirements and testing for biological evaluation EN 455-3:2023/prA1

Publication date:   Sep 25, 2025

General information

45.99   Dispatch of FV draft to CCMC   Sep 7, 2026

CEN

CEN/TC 205 Non-active medical devices

European Norm

11.140   Hospital equipment

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Draft

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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

Legislation 2017/745

Life cycle

PREVIOUSLY

PUBLISHED
EN 455-3:2023

NOW

IN_DEVELOPMENT
EN 455-3:2023/prA1
45.99 Dispatch of FV draft to CCMC
Sep 7, 2026




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