DS/EN 14683:2019+AC:2019

Medical face masks – Requirements and test methods


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
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Legislation:

Legislation

Harmonized under:
  • Council Directive 93/42/EEC of 14 June 1993 concerning medical devices

Harmonized standards:
Links

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 European Standard is not applicable to masks intended exclusively for the personal protection of staff.

NOTE 1 – Standards for masks for use as respiratory personal protective equipment are available.

NOTE 2 – Annex A provides information for the users of medical face masks.


Number of pages: 25

Published: 2019-08-15

Date of approval: 2019-08-12

International relationships : EN 14683:2019+AC:2019 IDT

ICS: 11.140 - Hospital equipment

Item number: M333905


Committees

Committee

  • CEN/TC 205
  • CEN/TC 205/WG 14

Danish committee

DS/S-448

Included in