What to look out for when considering surgical masks

Checklist for medical devices - surgical masks

Whilst this information can be viewed on an electronic device, you may find it easier to print as a handy reference tool but please ensure you are always using a print from the latest electronic version of this information as such can change.

About medical devices

  • Not PPE (Personal Protective Equipment)
  • Not designed to protect the wearer from airborne virus particles
  • Worn to limit transmission of virus to others
  • The MHRA (Medicines and Healthcare products Regulatory Agency) is the designated competent authority that administers and enforces the law on medical devices in the UK.

Legislation and standards

  • Medical Devices Directive 93/42/EEC (and the Medical Devices Regulation 2017/745 under transitional arrangements)
  • Harmonised Standards BS EN 14683:2019+AC:2009 (E)
  • Old versions of the standards are BS EN 14683:2005 and 2014

Classification of masks and performance requirements

  • Type I
    Bacterial Filtration Efficiency > 95%
    Differential Pressure <40 (Pa/cm²)
    Microbial cleanliness <30 (cfu/g)
  • Type II
    Bacterial Filtration Efficiency > 98%
    Differential Pressure <40 (Pa/cm²)
    Microbial cleanliness <30 (cfu/g)
  • Type II R (Fluid Resistant Type surgical mask)
    Bacterial Filtration Efficiency > 98%
    Differential Pressure <60 (Pa/cm²)
    Splash resistance >16,0 kPa
    Microbial cleanliness <30 (cfu/g)

Documentation

Non sterile face masks - Notified Body involvement is not required.

Documentation Item Is this required?
Declaration of Conformity Required
Third party Test Report Not required
Manufacturer Test Report demonstrating how the Essential Safety Requirements are met Required
CE Certificate Can be requested

NB If masks are described as 'sterile', a notified body must be involved for approving the sterile part of the production process.

Packaging and labelling

RequirementYesNoN/A
Description of Type of Mask (Type I, Type II, Type II R)    
BS EN 14683:2019 (not 2005 or 2014)    
CE Mark    
Name and postal address of manufacturer    
Batch code (LOT) or serial number    
Date by which device should be used (year and month)    
Any special storage and/or handling instructions    
Any warnings or precautions    
Year of manufacturer (can form part of batch/serial number)    
The word 'sterile' if applicable, including the method of sterilisation    
Intended purpose of device    
Whether reusable or not    
If reusable, instructions for cleaning    

NB Instructions for face masks can be minimal and information can take the form of symbols

Storage/handling instructions might include (including by way of symbols)

  • Do not touch mask with fingers/hands
  • Full hand disinfection required after mask removal
  • Mask to be work covering nose and mouth and, at no time, to be worn hanging round neck
  • Dispose of mask when no longer needed

Exemption from CE marking and Declaration of Conformity

For new Covid-19 face masks not previously placed on the market, providing that the product meets the essential criteria and the conformity assessment procedure has been started, there may not be a Declaration of Conformity and the product may not be CE marked. Documentary evidence of this should be requested. (Rules are different for Central Government/NHS purchasing.)

Information to be provided in test reports

Informative (not exhaustive)YesNo
Number and date of standard (BS EN 14683:2019)   
Lot number/batch code of masks tested   
Bacterial Filtration Efficiency   
Differential Pressure (breathability)   
Microbial Cleanliness   
Splash Resistance Pressure (synthetic blood test) for Type IIR masks only   

Requesting information

InformationYesNo
Description of product   
Model and batch/serial number   
Declaration of Conformity for the specific model of product being supplied   
Test report in English traceable to product being supplied, also links to Declaration of Conformity   
CE Certification (optional), links to Declaration of Conformity   
Photos of product   
Photos of all product labelling, including all relevant angles of packaging to enable required labelling to be checked   

Important

This checklist is not intended to be an authoritative interpretation of the law.

It is only intended to be used as a starting point for Local Authorities to check the status of face masks. It details the general documentation and information that should be requested and assessed when purchasing face masks.

Please refer directly to the applicable legislation, harmonised standards and current issued Government guidance for further detailed information.