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Hallmarks, markings and standards

Friday 28 May 2021

One of the things that we at Nobraa consider immensely important is to provide products of high quality. Especially when you operate in the medical world, in our opinion, the quality of the products can't leave much to be desired. Therefore, we guarantee that we only sell products that meet Dutch and European standards. 

But what do all those different types of markings, certificates and quality marks really mean? We will explain it to you in this blog. So that you can make an informed choice about which products you want to purchase and from which provider. And of course we hope that we are that provider! 

CE marking

‘CE' in the sense of the CE mark stands for 'Conformité Européenne'. This means: in accordance with European regulations. A CE mark therefore indicates whether a product complies with the rules for that specific product within the European Economic Area (EEA). 

At Nobraa we believe it is important to sell products that meet the requirements and regulations. Therefore we only sell products with a CE mark! Do you want to check whether a product indeed has this marking? You can recognize this by the letters 'CE' on the packaging of the products. 

CE marking without number

You may have noticed that many corona control products do not have CE marking with a number, like the 'normal' CE markings. This is because, due to the urgency of the crisis, manufacturers have sometimes not had enough time to meet all the legal requirements in the field of diagnostic testing. 

The government, including the Ministry of Health, Welfare and Sport and the RIVM, have opted to give these products a CE mark (but without a number). The manufacturers have received an exemption for these products. In this way, the government indicates that these products have indeed not been able to pass all the tests due to the rush, but are of sufficient quality and reliability to be sold on the market. 

An example of products that have received many such waivers are corona self-tests. On the website of the Dutch government is published which self-tests these are and which are therefore good enough to be sold on the Dutch market. The BIOSYNEX antigen test and the Acon Biotech antigen test that we sell at Nobraa are also listed.

NEN standards

In addition to CE marking, there are also NEN standards. NEN stands for ‘Nederlandse Norm’ (translation: Dutch Standard) and is an organization that ensures that parties in the Dutch market make agreements about the quality and safety of their products, services and processes. They ensure that companies and organizations enter into discussions and agree on certain standards in a specific field. 

The NEN is there for the Netherlands, but also for Europe and worldwide. The international standards accepted in the Netherlands are referred to as ISO or IEC, the European as EN and the national standards as NEN. These standards therefore say something about the reliability of products or services, such as in this case face masks or gloves.

EN149 standardization (medical FFP mouthguards)

Protective mouthpieces that have the NEN-EN149:2001+A1:2009 standard, such as our FFP mouthguards, meet the minimum European requirements for protection against particles. These masks filter the air, thus protecting the respiratory system. Thus, the FFP masks mainly protect the wearer.

According to the EN149 standards, there are three types of respiratory protection masks, namely the FFP1, FFP2 and FFP3 masks. All these masks have been tested for proper filter performance, leakage along the edges, breathing resistance and absorption capacity.

Two of these types of masks, which we also sell at Nobraa, are suitable (filter enough) to protect against the coronavirus. These are the FFP2 and FFP3 masks. The number after FFP (Filtering Facepiece Particle) indicates how well the mask filters.  

EN146 standardization (surgical masks) 

In addition to the EN149 standard, there is also the EN146 standard for surgical face masks. In contrast to FFP masks, surgical masks are devices that are primarily used when working with patients. They primarily protect the patient and to a lesser extent the wearer. 

These masks, which therefore mainly protect others from the viruses that the wearer might spread, must comply with the EN146 standard. This standard means that the design, construction, test methods and performance requirements have been tested and are sufficient to limit the transmission of infections/viruses from personnel to patients. Thus, mouthguards with this standardization are highly suitable for work in a healthcare facility such as a hospital or general practice. 

The surgical masks also have three types of gradations. The surgical masks are type I, type II and type IIR. For healthcare personnel, only type II and IIR are suitable, whereby IIR protects one degree better. Type IIR, unlike type II, works both ways. 

Foreign standards equivalent to (N)EN standards

Nowadays many products are produced outside the EU/EEA. This often says nothing about the quality of the products. Therefore, after consultation with the Social Affairs and Employment Inspectorate (in Dutch: Inspectie SZW) and the RIVM, the Healthcare and Youth Inspectorate (IGJ) has decided that some foreign standards are equivalent to European standards N-149:2001+A1:2009 and NEN-EN 14683:2019 for mouth masks. 

The standards in question are various Chinese standards and American standards. At Nobraa, for example, we sell the NPS 3-Layer Surgical Mouth Masks, which contain the standard GB/T 32610-2016. This is therefore equivalent to the Dutch standards! 

If you want to know more about which (other) standards are equivalent to the Dutch standards, click here for the information from the Dutch government.

EN455 standards (gloves)

Finally, an important standard to mention is the standardization for gloves. You can see from the standardization whether the gloves are suitable for certain activities and thus also whether they are suitable to protect against the coronavirus or not. 

Examples of standards are 374 for work with chemicals and/or micro-organisms and 407 for work involving fire and heat. The standardization of gloves that protect against the coronavirus is 455. This means that these are single-use medical gloves of sufficient quality to protect, for example, healthcare personnel and doctors.

TÜV Certificate/Approval (corona self-testing)

All corona tests sold by Nobraa that are suitable for self-testing/home use have a valid TÜV certificate in addition to the CE mark. This certificate, issued by the independent TÜV institute, shows that the product meets quality requirements, is safe and/or environmentally responsible. 

It checks whether the product complies with the rules laid down in legislation, the specific standards for the product and any quality marks. Examples include the (N)EN standards, EN standards, ISO standards or industry-specific quality marks. The TUV certificate also checks not only the company, organization or manufacturer that the products come from, but also the parties with whom business is done. 

Quality comes first 

By now it will probably have become clear to you that quality is of paramount importance to us at Nobraa. The quality of our products is extremely important to us, especially since it concerns medical products. We hope that this information has made you a lot wiser about all the labels, markings and standards, and that you can make a well-considered choice from our medical products. 

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