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cen:proj:79639

Respiratory infection prevention devices for self- and third-party protection - Part 3: Sustainability, human factors and rationales cen:proj:79639

General information

00.60 Close of review   Mar 1, 2024

CEN

CEN/TC 205 Non-active medical devices

Technical Report

Scope

This document provides information on sustainability and human factors in regard of respiratory infection prevention devices (RIPDs). In addition it provides some rationales for the requirements which are given in EN (WI 00205xxx).
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

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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

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Life cycle

NOW

IN_DEVELOPMENT
cen:proj:79639
00.60 Close of review
Mar 1, 2024