A medical-grade face mask is mainly used to protect the patient against infectious agents and
the wearer against potentially contaminated liquid droplets.

It can also be worn by the patient and, more generally, by other people to reduce the risk of spreading infection, especially during an epidemic or a pandemic.

A medical-grade face mask is classified according to the filtration efficiency and respiratory protection as envisaged by EN 14683, the technical standard which sets the requirements:

TYPE I

With a bacterial filtration efficiency (BFE) > 95% it can be worn by the patient to reduce the risk of spreading infections, in epidemic or pandemic situations.

TYPE II

With a bacterial filtration efficiency (BFE) > 98%,
it can be used by healthcare workers.

TYPE IIR

With a bacterial filtration efficiency BFE > 98%,
it is resistant to potentially contaminated liquid sprays and can be used by healthcare workers during surgical procedures.

How to proceed

For all three types (Type I, Type II and Type IIR), the medical grade mask must comply with the provisions of Regulation (EU) 2017/745. Our laboratories verify conformity according to the following standards:

EN 14683

Medical face masks – Requirements and test methods

ISO 22609

Medical face masks – Resistance to penetration by a splash of synthetic blood

EN ISO 10993-1

Biological evaluation of medical devices: Evaluation and testing

EN ISO 10993-5:

Biological evaluation of medical devices: in vitro cytotoxicity testing

EN ISO 10993-10

Biological evaluation of medical devices: Tests for irritation and delayed-type hypersensitivity

EN ISO 10993-18
Biological evaluation of medical devices: Chemical characterization of medical device materials within a risk management process
EN 1041

Information supplied by the manufacturer of medical devices

When testing is complete, you will have to:

  • prepare the technical file in compliance with Annex II to Regulation (EU) 2017/745
  • apply the CE marking on the Medical Device
  • prepare the EU declaration of conformity (Annex IV to Regulation (EU) 2017/745), complete with an indication of the SRN (supplier’s unique code) and UDI D (device’s unique code)
  • register with the Database of the Ministry of Health and the European EUDAMED

Intervention from a notified body is only required for face masks subjected to a sterilization process (Category Is).

Keep the EU declaration of conformity and the technical file for 10 years from when the Medical Device is placed on the market.

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