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

Medical face masks. Requirements and test methods

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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.

Tämän julkaisun valmistelusta Suomessa vastaa Yhteinen Toimialaliitto, www.ytl.fi.
Sidokset
Velvoittavat viittaukset
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)
Direktiivi
93/42/EEC Lääkinnälliset laitteet

http://ec.europa.eu »
Vahvistuspäivä
16.08.2019
Julkaisupäivä
20.08.2019
Painos
4
Sivumäärä
23
Julkaisun kieli
englanti

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