Mask CE Certificate
Masks have now become one of the most important and essential items for everyone in the COVID-19 process we are in. Many countries in the world attach great importance to the issue of masks and warn their citizens not to leave the house without a mask. In fact, various legal arrangements are made about it; even criminal proceedings are implemented. But to be truly protective, masks must meet certain quality standards. At this point, the fastest and most effective solution is Mask CE Certificate.
What is Mask CE Certificate?
Masks can be used for different purposes in different environments. For this reason, it is worth noting that Mask CE Certificate is arranged not for a single mask type but according to the place of use and risk class. For example, the characteristics of the masks used by someone working in a chemical process and performing surgical operations are very different from each other. Similarly, in the period we are in is that everyone uses disposable masks fall in a different class. However, the Mask CE Certificate covers all kinds of mask products, enabling mask manufacturers to produce masks in accordance with European standards. At this point, it is worth noting that this document is not a quality certificate, it means that the products it covers will not harm human or the environment.
Mask CE Certificate and Related Regulations
There are two different directives that companies producing masks as a personal protective equipment or medical equipment must follow to obtain a Mask CE Certificate. These directives, the latest versions of which are available on the European Commission´s website, are:
• 2016/425 Personal Protective Equipment (PPE) / Personal Protective Equipment (PPE)
• 93/42 / EEC Medical Devices / Medical Devices
At this point, Mask CE Certificate is issued based on 2016/425 if a mask production is made as PPE and 93/42 / EEC directive if a surgical mask is produced. On the above mentioned website, it can be seen which companies in our country have obtained CE Certificate under which directive.
Both regulations entered into force through harmonization on different dates in our country. These were published in the Official Gazette on May 1, 2019 as Personal Protective Equipment Regulation by PPE, Ministry of Family, Labor and Social Services. For many years, at an earlier date if applicable Medical Devices Directive, June 7, 2011 the Official Gazette published by the Ministry of Health has entered into force. this Directive for companies Mask wanting to get the CE Certificate, general requirements should bear the mask, the measures to be taken against the problems that will arise in the use of tests to be performed on the mask and gives much more.
How to Get Mask CE Certificate?
Regardless of the product it produces, the company, which wants to obtain a CE Certificate, must only contact accredited certification bodies in this regard. Mask CE Certificate, which is spread over a certain process and has different procedures, is also issued if the whole process is carried out in accordance with the relevant directives.
If companies that want to obtain the Mask CE Certificate receive training and consultancy services on this subject, the process can be completed much faster and at lower costs. At this point, as in many other CE Certificate regulations, if the related product does not fall into a risk class, the manufacturer companies can directly affix the CE mark on their products without any approval. However, if the masks to be used by people working in an operation or working area that involves risks such as health, hygiene, safety, etc. should be approved by accredited institutions for the Mask CE Certificate.
During the process it is in, the masks that we hear most often and continue to hear for a while should be CE Certified since they must meet certain criteria and are sent to European countries. Thus, it is declared that it meets all the necessary standards in health, environment and safety in the product category where the masks are included.
In the process of obtaining CE Certificate for these masks, mask production facilities of companies are inspected on site. In addition, it becomes imperative to perform some tests according to the properties of the product. These tests include nephral acceptability, microbial cleaning, bacterial filtration efficiency analysis. The more difficult and risky the process or working conditions in which the product is used, the number and type of tests required will increase.
The process of obtaining the CE Certificate of the mask manufacturers can take an average of 8 to 16 weeks depending on the parameters such as the density of the companies, the number of tests and analyzes, preparation of the technical file, etc. For this reason, it is useful to start working as early as possible in order to complete the certification processes for a moment. Especially the preparation of the technical file is one of the processes where the institutions wishing to obtain CE Certificate experience the most problems and lose time. However, if all steps are taken with the support of a consultancy firm, the process will become faster and easier.
Keywords: Mask CE Certificate
Meta article: This article contains information about the CE Certificate issued on masks used in different environments due to safety and hygiene.
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