PREMISE

On this page we try to shed light on some types of masks facial protagonists in these days of emergency Covid-19 and the different process production, control and marketing that characterize, as well as on our laboratory tests and analyzes the role of .

facial masks “surgical”

Facial masks for medical use (so-called "surgical”) Type I / II / IIR is a Category I Medical Device (simple devices) and are subject to CE marking according to the EU Regulation 2017/745 by the manufacturer no need to involve a Notified Body. This means that the manufacturer / importer can CE mark the template once it has verified that it meets all technical requirements specified in the reference standard IN 14683.

 

surgical Mask

surgical Mask

 

filtering face masks “DPI”

Facial masks filtering FFP1 / FFP2 / FFP3 They are Personal Protective Equipment (DPI) Category II (for medium risks) e III ( for risks of death or serious injury) and are subject to CE marking according to the EU Regulation 2016/425 by the manufacturer with the need to involve a Notified Body. This means that the manufacturer / importer can CE mark the template as a result of inspections, tests and checks carried out by a Notified Body. The reference standard that defines the technical features that the masks must comply with is the IN 149.

Masks dPI

 

New Procedures in derogation to Covid-19 Emergency

To face the emergency Covid-19, the Decree Law 17 March 2020, n. 18 provided all 'art. 15extraordinary provisions for the production of surgical masks and personal protective equipment – the ability to produce, import and enter in surgical masks and individual protective devices trade no CE marking, consent:

  • Institute of Health ISS → for surgical masks
  • INAIL for DPI filter masks

 

The procedures to follow to refer to IIS on the production requirements, import and marketing of masks surgical They are available on the web page:

https://www.iss.it/procedure-per-richiesta-produzione-mascherine

You can also find useful information in data sheet formulata da Confindustria Medical Devices and l 'Istituto Superiore di Sanita to identify the basic requirements for entry to medical use masks without CE marking on the market.

Download CHECKLIST : https://www.confindustriadm.it/wp-content/uploads/2020/03/Checklist-mascherine_def.pdf

 

The procedure to be followed for subjecting INAIL production requests, import and marketing of dPI masks They are available on the web page:

https://www.inail.it/cs/internet/atti-e-documenti/istruzioni-operative/istruzione-operativa-emergenza-covid-19.html

OUR ROLE

Pontlab, although not a specific laboratory test for facial masks, He has been involved since 29 February 2020 to provide support to the extent possible the evaluation of surgical masks New business, given the emergency situation of unavailability on the market CE marked masks, the manufacturers and the difficulty in finding equipped laboratories to perform tests in accordance with the technical standards quickly.

The first tests conducted were a comparative evaluation on the chemical and morphological composition the new production masks compared with a CE marked surgical mask reference. The results of these analyzes, as well as providing technical support for the provision in derogation of a batch of masks for the region Tuscany (Ordinance 17 of 19 March 2020), They may constitute a technical evidence of the mask produced by characteristics present in ISS attached to the authorization application in derogation production / marketing.

Pontlab He has expanded the offer for the execution of tests in accordance with the reference technique IN 14683, introducing the 25 March 2020 the proof of breathability and, from the 30 March, the evidence of bacterial filtration efficiencyBFE (simplified method compared to the aforementioned norm) it is to microbial cleaning test, in order to provide manufacturers / importers of surgical masks can provide a more comprehensive technical documentation ISS.

For more information or to request a quote for the test execution, we invite you to write to commerciale@pontlab.it

 

We recommend that you read and follow the links indicated to better understand the path required for the verification of their protective surgical masks.
We have set up a section where shows our responses to Frequently Asked Questions (F.A.Q.).