Neutral or colored, decorated or plain, masks are now an essential part of our clothing, if not a new fashion, unfortunately imposed by the pandemic. Aesthetics aside, the fundamental matters concern their real effectiveness against the risk of infection, the level of protection based on use and the need to meet the ever-increasing demand for surgical masks and Personal Protective Equipment (PPE).
In a scenario that, in order to respond to the pressing request for respiratory protection devices, requires continuous legislative interventions, also in derogation of the current regulations, accreditation is now fundamental, as a super partes guarantee tool, to protect quality and safety of products placed on the market.
Derogation for the assessment of masks
To deal with the surge in demand throughout the European Union, in fact, with the EU Recommendation 2020/403, in March the European Commission provided for the possibility for Member States to authorize derogations to the conformity assessment procedures for manufacturing, import and placement of PPE and medical devices on the market. The Italian Government, with the Legislative Decree 18/2020 of last March 17 and the subsequent conversion in law 27/2020 of April 24 (“Cura Italia” Law), introduced a simplified procedure for the conformity assessment – which exclusively concerns the procedure and the related timing, not the quality standards provided by current regulations, which must always be respected – and equated with PPE surgical masks under certain conditions “to contain the spread of the COVID-19 virus, until the end of the state of emergency … for workers who are objectively unable to maintain an interpersonal distance of one meter while carrying out their activities”.
The new Article 66 bis of Law 77/2020 of July18 (conversion of Legislative Decree 34/2020, the so-called “Rilancio” Decree) confirmed and extended this extraordinary procedure until the end of the health emergency. In this context, the use of masks without the CE mark is also allowed, subject to evaluation by the Istituto Superiore di Sanità (ISS). To make use of the derogation, anyone who manufactures, imports or places surgical masks on the market must therefore send a self-certification attesting their technical features to the Istituto Superiore di Sanità (ISS), together with the declaration that they comply with the safety requirements of current legislation.
Accredited tests for surgical masks
It is clear how, in the face of a simplification of procedures, it is even more important to guarantee the quality, efficacy and safety of products placed on the market, entrusting the verification of their conformity to the competence, independence and impartiality of accredited bodies and laboratories. Even pending the derogation, in order to be placed on the market, surgical masks – such as PPE for the respiratory tract – must be verified and tested to ensure their functionality and ensure compliance with the minimum requirements for protecting health.
Surgical masks manufacturers must demonstrate, submitting tests carried out by competent laboratories, that their products meet the essential requirements provided by the harmonized reference standards, including UNI EN 14683:2019, which provides for bacterial filtration efficiency (BFE), i.e. the ability of the fabric to place a barrier to the penetration of microorganisms, breathing resistance, i.e. the measure of air permeability, splash resistance, microbial cleanliness (bioburden) and biocompatibility tests.
On June 23, Accredia issued the first accreditation in Italy to a laboratory that carries out the filtration efficiency test of surgical masks, according to the method indicated in the UNI EN 14683 standard, Appendix B. The accredited laboratory has successfully passed the assessment, performed by an Accredia assessment group, which verified the competence of the staff, the suitability of the testing instruments and the ability to provide reliable results.
Several laboratories are already accredited for the other tests provided for by the same standard and their data have been included by European Accreditation (EA) in a new European database of accredited laboratories that carry out tests for PPE and surgical masks, in compliance, respectively, with the standards UNI EN 149 and UNI EN 14683.