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cen:proj:79637

Respiratory infection prevention devices for self- and third-party protection - Part 1: Requirements and marking cen:proj:79637

General information

10.99 New project approved   Jun 17, 2024

CEN

CEN/TC 205 Non-active medical devices

European Norm

Scope

This document specifies the minimum functional and performance requirements 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 also reduce exposure to the user from inhalation of infective agents.
RIPDs are intended for use by everybody regardless of facial morphology or ability.

Related legislation

Legislation related to this standard

2016/425

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

Legislation 2016/425
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

NOW

IN_DEVELOPMENT
cen:proj:79637
10.99 New project approved
Jun 17, 2024