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WHO / Rada Akbar
Mobile Clinic Afghanistan. A midwife listens to the heartbeat of a pregnant woman at the mobile clinic organized by WHO at the Garm Abak of Waras district in Bamiyan, Afghanistan.
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Call for public consultation - Technical specifications for prequalification (PQ) of medical masks

1 September 2022
Call for consultation

Deadline extended to 10 October 2022, 12PM CEST

The World Health Organization (WHO), is seeking feedback on the attached technical specifications for prequalification of medical masks. The call is opening 1 September 2022.

The purpose of the document is to provide technical guidance to medical device manufacturers that intend to seek WHO prequalification (PQ) of medical mask. The document include the technical specifications for PQ of medical mask for the following: 

  1. the scope of this publication will only focus on medical mask 

  2. excluded medical masks that include drugs, biologics, nanoparticles, or antimicrobial/antiviral agents and  

  3. excluded reusable mask, respirator, community mask 

 The intended use of the medical mask is as follows: 

  1. used by healthcare workers (HCW)Type II medical mask and patient /community, Type 1 medical mask as a barrier to help protect them from liquid splashes and sprays, such as blood, that they may be exposed to during certain medical procedures.  

  2. used to help capture some particles and droplets expelled by the wearer, such as those that may contain viruses and bacteria. (Source control) 

 The medical mask is to be used for the prevention of the transmission of air borne diseases or for infection prevention or reduction, including against SARS-CoV-2 and used in clinical, medical use, or use in other health services or in community settings 

 

Comments can be submitted to  medicaldevices@who.int using the following form.