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EN 14683:2019+AC:2019 Standard

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  Keywords:

#medical #personal #note #staff #agents

  Directive

Medical devices Directive (93/42/EEC)

  Last Official Journal reference

Wednesday 14th of April 2021

  Description:

Medical face masks - Requirements and test methods

  Purpose

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.

  Publication

Wednesday 25th of March 2020

  Related Standards

EN ISO 21649:2009

Medical devices Directive (93/42/EEC)

Needle-free injectors for medical use - Requirements and test methods (ISO 21649:2006)

EN ISO 10993-1:2009/AC:2010

Medical devices Directive (93/42/EEC)

Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009)

EN ISO 10993-7:2008/AC:2009

Medical devices Directive (93/42/EEC)

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008)

EN ISO 10993-7:2008

Medical devices Directive (93/42/EEC)

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008)

EN ISO 10993-6:2009

Medical devices Directive (93/42/EEC)

Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2007)

EN ISO 10993-5:2009

Medical devices Directive (93/42/EEC)

Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)

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