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CEN
CEN/TC 205 Non-active medical devices
European Norm
This document specifies the minimum functional and performance requirements and test methods for respiratory infection prevention devices (RIPDs).
RIPDs are intended to reduce the emission of infective agents from the user’s airways into the environment, and to reduce the exposure to the user from inhalation of infective agents.
RIPDs are intended for use by everybody regardless of age, facial morphology or ability.
Legislation related to this standard
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
Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal protective equipment and repealing Council Directive 89/686/EEC
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