2020-04-21

CLARIFICATION ON PROTECTION MASKS (Covid-19 )

As is well known, the masks useful for protecting people and their respiratory tract are called PPE (personal protective equipment).

The masks call instead "masks surgical " are used to protect the environment (so when used by a physician, surgeon, etc.) ,to protect the patient and they are medical devices .

Both types of masks are subject to CE certification :

- in the first case PPE fall within the scope of REGULATION 2016/425 / EU of individual protection devices

- in the second case fall within the scope of DIRECTIVE 93/42 / EU medical devices.

It means that each of the two products is subject to certification process required by directives or regulations applicable and therefore must bear the CE symbol.

Follow the certification process means that the masks of both categories, before being placed on the European market, must be compliance to the harmonized standards that determine whether the mask is suitable for the purpose for which it was born.

The standards in question are as follows:

EN 140 for PPE

EN 14683 for surgical masks

To comply with the purpose means that an institution and / or a laboratory have carried out tests according to the standards mentioned above and have issued a test report or certificate demonstrating the conformity of the object.

LET'S TALK ABOUT CERTIFICATES

With the outbreak of the Covid-19 virus the sale of masks also exploded and with it the issue of certificates by more or less serious entities, which helped create a lot of confusion, but above all have made possible buyers of masks that they were compliant with the CE marking process.

This type of certificate is known to our staff as having several importers of products as customers, we often run into this type of misleading certification.

The “misleading” word , in this moment of particular emergency, is a term that best describes the situation that has arisen.

According to the definition MISLEADING  means:

which distances and distracts from true, which leads to error, which puts us astray

In fact, if I am purchasing masks and I am shown / sent a certificate, perhaps issued by a notified body, the certificate / attestation / verification or other name with which these documents are issued , is expected to certify that what I am buying complies with current regulations .

Unfortunately this is not the case; if instead of trusting the certificate sent, I also try to understand what has been sent, one can guess that actually the certificate issued by the body expresses something else entirely.

In most cases, the certificates issued indicate that the product manufacturer has obtained approval to be able to mark the product itself with the voluntary mark of body that is issuing the certificate , in other cases the certificate indicates that the body has read the documentation, but also indicate that the certification process is the responsibility of the manufacturer. In both cases the conformity of the masks with the relevant standards or directives is not being declared.

Certificates are often issued by notified bodies that have obtained a notification (ie are specialized) to a directive or regulation completely different from the purpose specified in the certificate of mask ; for examples: a certification body for the machinery directive issues a certificate of conformity for masks that do not fall within the scope of the machinery directive but rather in the PPE directive ; so this situation should already suggest the value of that certificate…

If certificate not clearly stated that the product complies with specific standards and / or specific product directives , that certificate is unlikely to have a validity capable of demonstrating that the product has been CE marked following the practices required by the directives.

It is therefore necessary to pay close attention to what you are evaluating, buying and above all using .

If I am using a mask thinking that this has been certified, as I have received a nice certificate from a notified body, but without carrying out an accurate verification of the same certificate, I am making a serious mistake that can be dangerous for ourselves and for others .

Another very important topic concerns the sale of masks born overnight, from more or less serious manufacturers and or importers .

The conversion of a company into a manufacturer of masks is commendable but we must always keep in mind what kind of type of masks the company begins to produce or import.

If the masks are not certified, or there are no demonstrations that the fabric used has the same filtering effect as the certified masks (whether they are PPE or surgical), they risk generating apparently invisible damage, but with harmful consequences , especially if  masks are used in healthcare environments.

Masks with CE marking are often found on the market, flashy symbols that suggest that that particular mask can filter anything ( Covid - 19 included), but in reality if you read the instructions or warnings carefully (which must be delivered upon purchase of the mask!!!) , often written in English or with  microscopic font , you can understand that the aligners are not a PPE, are not medical devices and are not ............ (etc ..)

Masks are often accompanied by the writing of hypothetical standards or directives, without even being aware of which products these directives or standards apply to.

For example if I write that a mask conforms to DIRECTIVE ROHS, should know that the Directive Rohs applies to EEE (electrical and electronic equipment) as defined in Article 3 point 1 of the directive ROHS 2011/65 / EU; a mask is definitely not an EEE.

As well as declaring compliance with Directive 2001/95 / EC on general product safety ,which contains the main safety provisions that must be respected for many consumer products:

Article 3

1. Producers shall be obliged to place only safe products on the market.

2. A product shall be deemed safe, as far as the aspects covered by the relevant national legislation are concerned, when, in the absence of specific Community provisions governing the safety of the product in question, it conforms to the specific rules of national law of the Member State in whose territory the product is marketed, such rules being drawn up in conformity with the Treaty, and in particular Articles 28 and 30 thereof, and laying down the health and safety requirements which the product must satisfy in order to be marketed.

The same directive shows that alone it is not enough to consider a safe product, but that specific Community provisions for that type of product must be applied, if present .

(For example, in the case of a mask declared not medical, not ppe, if it is not a toy there are no other directives involved and therefore only in that case can reference to the general product safety directive )

It should be borne in mind also that in Italy with the decree n. 18 of 17 March 2020 article 15, the ministry has issued an extraordinary provision for the production and import of surgical and PPE masks.

The decree indicates that if a company intends to produce, or import masks defined as PPE or surgical, on an extraordinary basis, it is possible to obtain the authorization for sale, without having to proceed to the complete CE certification process required by the directives, by sending the documentation to Inail (for PPI devices) or to ISS the Higher Institute of Health (for surgical masks). The bodies mentioned above within about 6 days confirm and possibly authorize the sale of the masks.

LAST IMPORTANT CONSIDERATION ON PPE AND THEIR CERTIFICATES

The presentation of a certificate or trusted report has no value if the code of the mask or other object indicated on the certificate or report is not found on the same object.

If the certificate or report correctly reports standards and directives, it indicates that the product is compliant, it indicates that the tests have been carried out on the TY2020 mask model, but this code does not appear on the mask, on the packaging, on the box, or on the packaging, how can i say that the masks are the same and that comply with the rules?

Here are some useful links.

Link Accredia (ente accreditamento enti notificati) Come valutare la conformità di un certificato

Link per decreto articolo 15 disposizione straordinarie mascherine

Link per Nando (elenco enti notificati per direttive o nazione) dispositivi DPI

Link per Nando (elenco enti notificati per direttive o nazione) dispositivi medicali

Link certificati sospetti Federazione europea sicurezza