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prБДС EN 455-3:2022

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

General information

45.99     Sep 15, 2022

50.20    Nov 10, 2022



European Standard


Appropriate for SMEs


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.

Directives and Regulations

When the standard is harmonized under a directive or regulation, the word Harmonized appear. When such an inscription does not appear, it means that the standard is related to / supporting the relevant directive or regulation.


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

Life cycle


БДС EN 455-3:2015


prБДС EN 455-3:2022
45.99 Dispatch of FV draft to CCMC
Sep 15, 2022

Related project

Adopted from FprEN 455-3