SFS-EN 14683:2019 + AC:2019:en

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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 European Standard is not applicable to masks intended exclusively for the personal protection of staff. NOTE 1Standards for masks for use as respiratory personal protective equipment are available. NOTE 2Annex A provides information for the users of medical face masks.

The standards writing body responsible for this document in Finland is General Industry Federation.

Product group(s)

11.140 Hospital equipment »

Relationships

Normative references

EN ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009)
EN ISO 11737-1:2018 Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2018)
ISO 22609:2004 Clothing for protection against infectious agents -- Medical face masks -- Test method for resistance against penetration by synthetic blood (fixed volume, horizontally projected)

Technical committee

CEN/TC 205 Non-active medical devices »

Directive

93/42/EEC Medical devices

http://ec.europa.eu »

Date of implementation

16.08.2019

Published

20.08.2019

Edition

Pages

Language(s)

English