Overview

This standard 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 interventions in operating rooms 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. In respect to DIN EN 14683:2006-02, the following changes have been made: a) change/extension of title and scope to the more general and broader use for medical face masks; b) adjustment of the requirement to ISO 22609 concerning the request for resistance to liquid splashes; c) addition of requirements for microbiological purity and general biocompatibility; d) adjustment of Table 1 on performance requirements for medical face masks; e) update of Annex A on user information; f) complete revision of Annex B on method for in-vitro determination of the bacterial filter performance in particular with regard to the testing conditions and the structure of the test apparatus; g) complete editorial revision, including update of all normative references, the Bibliography and Annex ZA on the relationships to the EU Directive 93/42/EEC. This document (EN 14683:2014) has been prepared by CEN/TC 205 "Non-active medical devices", the secretariat of which is held by DIN (Germany). The responsible German body involved is NA 063-01-08 GA "Gemeinschaftsarbeitsausschuss NAMed/Textilnorm: Operationstextilien" ("Joint working committee NAMed/Textilnorm: Surgical textiles").

Document: references other documents

Document: referenced in other documents

Responsible national committee

NA 176-04-07 AA - Surgical textiles  

Responsible european committee

CEN/TC 205/WG 14 - Surgical clothing and drapes, and medical face masks