Personal Protective Equipment CE Certificate
Personal protective equipment CE Certificate is issued for protective equipment with certain features. Manufacturers covered by the EU regulations in force regarding these products are required to obtain a CE Certificate of personal protective equipment. In this way, the risks that threaten human health and safety during the design, production and use of the products can be minimized. Personal protective equipment products with CE Certificate can easily be offered to the European market, as in other CE certified products. Manufacturers who want to have a certificate may need to work with notified bodies according to the risk level and category of the product.
What is Personal Protective Equipment CE Certificate? What is the Personal Protective Equipment Regulation?
CE Certificate is issued for personal protective equipment within the scope of 2016/425 (EU) Regulation. This regulation is valid 21 April 2018. With the entry into force of Regulation 2016/425, the previous Directive 89/686/EEC has been repealed. This regulation has been harmonized and published in our country within the scope of harmonization with EU legislation. On May 1, 2019, the Personal Protective Equipment Regulation published in the Official Gazette No. 30761 by the Ministry of Family, Labor and Social Services entered into force and the previous regulation based on 89/686/EEC has lost its validity.
The 2016/425 Regulation specifies the basic health and safety requirements that the product must meet in order for manufacturers to obtain the CE Certificate of personal protective equipment. The regulation defines personal protective equipment as: Equipment designed and manufactured to be worn or held to protect against health and safety risks. The replaceable components of these equipment can also be included in the category of personal protective equipment. More detailed information about product definitions is available in the regulation.
There are three different risk levels for protective equipment in the regulation. Category 1 consists of products designed to protect the user against minimum risks. Category 3 includes products designed to protect the user against very serious risks. Category 2 covers equipment not listed in these two categories.
The Personal Protective Equipment Regulation also defines the common features applicable to products in each risk group. These are parameters such as ergonomics, suitable material, comfort and efficiency, lightness and durability, etc. In addition, specific criteria are explained for different products in different risk groups. In order to obtain the CE Certificate of personal protective equipment, these criteria must be met and the international standards of the relevant product must be complied with.
How to Get Personal Protective Equipment CE Certificate?
One of the most critical issues for personal protective equipment is whether there is a need for a notified body in the CE certification process. At this point, there is no need for a notified body for products that fall into category 1 at the risk level. In other words, the manufacturer can make the declaration of conformity directly himself. However, a notified body is required for products in the other two categories. All studies required for CE Certificate of personal protective equipment; tests, analyses, documentation, preparation of the declaration of conformity and the EU type-examination certificate etc. should all be carried out under the supervision of the notified body. These organizations also visit the production facilities of the manufacturer and verify that the works during the production phase are also carried out in accordance with the requirements of the regulation.
Another important issue for obtaining documents is of course the preparation of a technical file. The manufacturer, alone or together with the notified body, prepares a technical file to show that the product to be certified meets the health and safety requirements. We can summarize what should be in this file as follows:
• Definition of the product and its intended use information.
• Risk analyzes
• List of health and safety requirements
• Technical drawings of the product
• Referenced standards, specifications and regulations
• Calculations, analyzes and tests performed and reports on them
• User manual of the product
• Instructions used in single and mass production
After the health and safety requirements of the products are verified in accordance with the regulation and the production sites are inspected and the detected nonconformities are closed, the CE certification process is completed.
Personal Protective Equipment CE Certificate Benefits
The definition of personal protective equipment is quite wide and these equipments are used in many different sectors. In this context, we can say that the European Union countries are also a good market in this regard. However, personal protective equipment CE Certificate is needed in order to enter the product in this market. Manufacturers can import these products to Europe by obtaining CE Certificate. Because this document allows products to circulate freely within the EU. provides the cost.
Manufacturers who obtain the CE Certificate of personal protective equipment can also increase their reputation in the eyes of their stakeholders. Because customers always prefer reliable and certified products more. In this way, companies can gain a competitive advantage in the market.