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 related to this standards.
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
Replaces
SSH EN 455-3:2015
IN_DEVELOPMENT
prSSH EN 455-3:2023
40.20
DIS ballot initiated: 12 weeks
May 9, 2024
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Shqip