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prEN 14683

Medical face masks - Requirements and test methods prEN 14683

Publication date:   Aug 31, 2023

General information

40.60 Close of voting   Nov 23, 2023

CEN

CEN/TC 205 Non-active medical devices

European Norm

11.140   Hospital equipment

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Scope

This document specifies construction, design, performance requirements and test methods for medical face masks intended to limit the transmission of infective agents from staff to patients during surgical procedures and other medical settings with similar requirements. A medical face mask with an appropriate microbial barrier can also be effective in reducing the emission of infective agents from the nose and mouth of an asymptomatic carrier or a patient with clinical symptoms.
This document is not applicable to face masks intended exclusively for the personal protection of staff.

Related legislation

Legislation related to this standard

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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EN 14683:2019+AC:2019

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prEN 14683
40.60 Close of voting
Nov 23, 2023