What to look out for when considering Personal Protective Equipment

Checklist for personal protective equipment (PPE) - FFP type face 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 personal protective equipment face masks

  • Distinguish from face masks which are medical devices (type I, II or IIR masks)
  • Designed to protect the wearer of the equipment
  • PPE face masks designed to protect from Covid-19 are Category 3 PPE
  • Claims relating to 'protection', 'virus' and 'bacteria' will indicate whether the face mask is intended to protect the user
  • The HSE (Health & Safety Executive) is the enforcement body for PPE supplied for use at work

Legislation and standards

  • Regulation (EU) 2016/425 on personal protective equipment
  • Harmonised Standard 'BS EN 149:2001+A1:2009'
  • Regulation (EU) 2016/425 repealed council directive 89/686/EEC
  • Previous standard was En 149:2001

Classification of masks and performance requirements

PPE masks are respiratory protective devises - filtering half masks to protect against particles. Only masks of class FFP2 or FFP3 would be suitable to protect against airborne virus particles.

  • FFP1
    Lowest level of protection, not considered suitable for use for Covid-19
  • FFP2
    Considered the European Equivalent of N95 Respirator Mask (the US specification)
    Filters 94% of airborne particles
  • FFP3
    Protects against liquid and solid aerosols
    Offers highest level of protection
    Filters 99% of airborne particles

Masks may be valved or unvalved.

Documentation

Documentation must be supplied by the manufacturer in English and accompanying every smallest available commercial package.

Document itemIs this required?
Declaration of Conformity including name and number of notified body Required
Third Party Test Report confirming that the product meets the Essential Safety Requirements, including name and number of notified body Required
Manufacturer Test Report Not required
CE Certificate including name of notified body Can be requested

Packaging and labelling

RequirementYesNoN/A
Description of Type of Mask ie 'Particle Filtering Half Mask'    
Classification and whether reusable or not (R or NR) eg FFP2 NR    
Reference to the Standard ie EN 149:2001    
CE Mark with reference to the 4 digit notified body number    
Name (or registered name or trademark) and postal address of manufacturer    
Batch code or serial number allowing identification of PPE    
Shelf life of mask (at least the Year and optionally the month (yyyy/mm) (egg timer pictogram)    
Storage conditions to be observed, including temperature range and maximum humidity of storage (thermometer and umbrella pictograms)    
Warning to check fit prior to use    
Warning that requirements for leakage are unlikely to be achieved if facial hair passes under the face seal    
For non reusable face masks, a warning not to be used for more than one shift    
The statement - See information supplied by manufacturer (the book with 'i' pictogram)    
Recommended warning to not be allowed to hang from neck of wearer    
Recommended warning not to touch mask with fingers/hands once put on    

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

Masks should be described with reference to the type of mask, the reference to the standard, the class and whether the mask is reusable or not (R or NR) eg Particle Filtering Half Mask, EN 149:2001 FFP2 NR.

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 ie the manufacturer has contacted an authorised notified body, there may not be a Declaration of Conformity and the product may not be CE marked. Documentary evidence of this shoudl be requested.

(Rules are different for Central Government.NHS purchasing.)

Visual examination of product

  • Parts of the mask coming in to contact with the user must not have sharp edges or burrs.
  • Should be adjustable and sufficiently robust to hold in place.
  • Fastening should be secure.
  • Head harness should be comfortable.
  • Packaging should protect masks from mechanical damage and contamination.

Information to be provided in test reports

Information (not exhaustive)YesNo
Detail of notified body name, address and number   
Number and date of standard (BS EN 149:2001+A1:2009)   
Lot number/batch code of masks tested   
Packaging test   
Material test   
Cleaning and disinfection test for reusable masks   
Practical performance testing   
Finish of parts testing   
Total Inward Leakage testing (face seal leakage, exhalation valve leakage (if fitted), filter penetration) using 50 samples (10 subjects, 5 exercises)   
Compatibility with Skin test   
Flammability test   
Carbon dioxide content of inhalation air test   
Head harness test   
Field of Vision test   
Exhalation valve test (if one or more exhalation valves incorporated in mask)   
Breathing resistance test   
Clogging test   
Demounable parts test (if any are fitted)   

Requesting information

InformationYesNo
Description of the product eg Particle Filtering Half Mask, EH 149:2001 FFP2 NR   
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 Certificate (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.