A guide to understand how to unmask scams and buy safe and certified surgical masks or Ffp2.
There seem to be thousands of counterfeit masks, the "false" ones you have to keep away from. Yet the Ffp2 should protect us from the coronavirus, but their effectiveness could be compromised precisely if they are not in accordance with the law.
Many have been the seizures of Nas in recent days and if on the one hand now a useful tool helps us to understand who certified our protection device, on the other there are many ways for us consumers to understand if a mask has been entered. marketed illegally.
Read also: FFp3 masks: differences with FFp2, how long do they last and are they reusable?
What seems certain, in short, is that the rules are sometimes not respected. With the help of Clariscience, the Padua-based company that oversees the entire supply chain, we tried to understand how to unmask scams and buy safe and certified masks.
Clariscience analyzes the documents, while the technical analyzes aimed at understanding whether a mask filters exactly as it should are performed by specialized laboratories. If bogus, the documents accompanying the devices are often prepared by experts: in this case it is possible to understand that it is a fake only by contacting directly the notified body that appears to have issued the certificates.
To help companies and consumers to extricate themselves from the complexity of rules and laws, here is a small handbook.
Vademecum to understand if an FFP2 or surgical mask is not up to standard
Le Surgical masks, by law, are classified as medical devices and, as such, they must ensure not only compliance with the general regulation of medical devices (Dir. 93/42 / EEC), but also meet the requirements imposed by the technical standard EN 14683, which outlines the minimum performance in terms of effectiveness filtering and breathability.
The packaging must therefore contain:
- il CE mark, placed on the product to guarantee compliance with current regulations (Directive 93/42 / EEC or EU Regulation 2017/745)
- the reference to EN 14683: 2019, a technical standard that establishes the minimum requirements of filtering capacity and breathability of masks for medical use (indication of the type of mask: Type I, Type II or Type IIR)
Furthermore, compliance with the law requires that the packaging of the surgical procedures be marked:
- il manufacturer, that is, who produced them or had them produced by third parties, based in the EU if necessary
- il leader, i.e. the company in the EU that represents a non-EU producer
With these data, together with the trade name of the mask, you can also check the presence of the device in the database of medical devices of the Ministry of Health.
There are personal protective equipment filter masks such as FFP2 and FFP3, which are PPE belonging to risk category III and as such must comply with the provisions of EU regulation 425/2016: this means that in order to be put on the market they must be evaluated by a notified body designated for the certification of road protection devices respiratory.
The notified body verifies and certifies that the product meets the requirements of the regulation: as an individual protection device, the filter mask must have a high filtering capacity against very small particles and droplets and excellent breathability: performances that are guaranteed if the manufacturer has complied with the requirements established in the technical standard EN 149: 2001 + A1: 2009, specific for facial filters.
Together with the reference to the technical standard, the filter mask must report the CE mark on the packaging or product, affixed to guarantee compliance with current regulations. In the case of PPE such as FFP2 and FFP3, the CE mark appears accompanied by a code of 4 numbers, which identifies the notified body that has certified the conformity of the product to European standards. Know that the CE mark, by law, must have precise proportions. If the brand is different or has different proportions, then it is possible that it is counterfeit and the product does not ensure compliance with the safety standards imposed by European regulations.
HERE also other useful information.
- The scam of the "fake" FFP2 and FFP3 masks: how to recognize the certified ones