The CE mark or the old EC mark is an incoming mark used in the European Union to indicate that the product complies with the relevant EU directives, meets the requirements for product safety in the EU and ensures free movement in the European market (European Economic Area).
The letters CE are the abbreviation of the French expression "Conformité Européene" which means European Conformity in Turkish. The CE mark logo does not consist of only two letters. This logo, which has been carefully drawn technically, fits the original proportions when it is reduced or enlarged.
Use of CE Mark
The CE mark indicates the product's compliance with EU legislation on safety, health and environmental protection. If a CE mark is placed on a product, the manufacturer of the product declares that the product complies with all the necessary requirements of the European Commission instructions applicable to the product in question.
Not all products need CE marking. Obtaining the CE marking is necessary when there are specific situations that a product must fulfill, or if there are various European Commission instructions for the product. Among the product categories that require CE marking are radio and telecommunications terminal equipment, medical devices, elevators, personal protective equipment, toys and cooling devices.
Advantages of the CE Mark for Your Organization
- Provides the free circulation of the products of your organization within the European Union Economic Zone.
- For products, there is no need to meet individual standards for all countries in the European Union Economic Zone.
- Makes products safer for users
- Helps you reduce potential damage and liability claims through reliability of products
Certification Process of CE Mark
CE mark is a requirement for the European Union. However, only products designed or produced in this area do not comply with this requirement. Non-EU manufacturers who want to move their products to the European market are obliged to obtain the CE mark for their products in order to ensure compliance.
Since the CE mark means that the manufacturer declares that the product complies with the relevant prohibited requirements and confirms that the necessary evaluations have been completed, all responsibility belongs to the manufacturer. The following steps are followed to obtain the CE mark.
- Determination of product-specific applicable instructions
- Determination of product-specific applicable harmonized standards
- Verification of product specific requirements
- Conducting an independent conformity assessment
- Testing the product
- Checking the product's compliance with EU legislation
- Preparation of technical documents required by the instructions
- Attaching the CE mark to the products
- Acceptance of the EU Declaration of Conformity
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From the past to the present, mankind has dealt with many different epidemics, making it obligatory to be protected from them. Today, there are many different viruses such as Corona, Ebola, Sars and so on. The golden rule to avoid this is to use a medical mask. There is a set standard for this and this is called the Mask Ce certificate . It is determined by the European Union.
Which Masks Seek Ce Symbol?
It is essential to have this symbol on the surgical mask, which is known as surgery and is used today in global pandemic periods. The same should be said about the personal protective mask. It is imperative that face masks in the textile industry are produced according to these standards. Apart from this, it is also a condition sought in medical mask and medical mask. From this point of view, it is necessary to say that it is a must.
How to Obtain Mask Ce Certificate?
- In order to obtain a Mask Ce certificate , it is necessary to apply through the institutions authorized in this regard.
- There is a conformity assessment.
- All of the institutions that will do this have the mandate given by the EU.
- Accordingly, the document is defined according to the surgical purpose and sterility.
- The risk value is taken into consideration and it is applied with special tests.
- Some tests are carried out, especially in laboratories that are defined as accredited.
- Documentation is provided without any problems regarding compatibility.
- It has a certain usage period and this is determined as 5 years.
What Tests Are Performed While Issuing Mask Ce Certificate?
The tests at the stage of issuing mask Ce certification are multiple. It is possible to summarize them as follows;
- Bacterial Filtration efficiency, known as BFE, is one of the most remarkable applications. The product must surpass this.
- Biocompatibility is always sought. In the absence of this, no certificate is issued.
- There is also a splash resistance test expressed as synthetic blood.
- Whether the product complies with microbial cleaning rules is always of utmost importance.
- Finally, I have to talk about breathability. A mask must not prevent the wearer from breathing. In other words, healthy breathing must continue despite the mask.
The mask, which successfully passes all of these, has the current standard.
What is the Importance of Mask Ce Certificate?
Mask Ce document is literally a must for manufacturers who want to sell in both Turkey and Europe. Otherwise, it is not possible to sell. Since the subject is human health, this is done very often. In the meantime, if possible deficiencies are detected, extremely severe criminal proceedings are applied. That's why certification is essential. Only then is the CE symbol placed on the product. After the receipt of the document, the declaration defined as self-declaration must be made as soon as possible.