TULUM CE CERTIFICATE
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.
One of the products whose use and importance is increasing due to epidemics such as SARS, Coronavirus, Ebola and MERS-CoV that have emerged in recent years are overalls. Overalls differ depending on where they are used. These overalls, whose general purpose is to protect the human body from pollution, germs, viruses and bacteria, according to the places they are used; They can be classified as overalls, surgical overalls, medical overalls, pilot overalls. Protective coveralls help to protect the human body from harmful effects in risky areas. CE certification is required for personal protective equipment within the scope of the Personal Protective Equipment Regulation. First of all, it is necessary to determine which category the overalls fall under.
Protective coveralls are only commercialized with the two listed product directive categories.
These;
* Personal Protective Equipment (EPI): 89/686 / CEE European Directive; Spheres, protective gear, and face masks (FFP) are available.
* Medical Devices (PS): 93/42 / CEE Directive; There are disposable clothing such as overalls, white coats, and surgical masks.
CE Certificate Overalls Categories:
* Liquid Chemical Protection Suit CE Certificate
* Pathogenic Organism Protection Suit CE Certificate
* Radioactive Protection Coverall CE Certificate
* Virus Protection Overalls CE Certificate
* Disposable Coverall CE Certificate
* Personal Protective Coverall CE Certificate
How to get CE Certificate for Personal Protective Coverall?
Based on the purpose of use and the degree of risk, protective coverall manufacturers should apply to international inspection organizations that have knowledge and authority in the relevant field for their conformity assessment studies. Notified Bodies have been authorized by the European Union within the scope of the Personal Protective Equipment Regulation to evaluate all these processes. Notified bodies carry out inspections for personal protective clothing (overalls) according to the 2016/425 / EU Personal Protective Equipment Regulation, and if all processes are found to be suitable, they issue a Certificate of Conformity to manufacturers to affix the CE mark on their products. In the examinations, these conformity assessment processes are handled according to many modular approaches and special tests are required according to the risk value of the product. In CE marking processes, technical file examination, testing in Accredited Laboratories, and then CE Certificate process is passed according to compliance. Companies that have CE certificate approval for Personal Protective Coveralls can use this document within the period specified by the conformity assessment module they have made. For some studies that do not involve any risks and do not require any special cases, manufacturers can offer their products to the market by publishing their own declarations.
As mentioned above, specific tests may be required for products requiring Notified Body inspection. Manufacturing companies can have various tests for their personal coveralls in accredited laboratories according to the risk levels and usage areas of their products. These tests are generally; Permeability Test, Deterioration Test, Physical Strength Test, Fire Resistance Test etc. It consists of tests.
Manufacturer companies can apply to the companies that issue CE certificate and have their personal protective clothes examined and affix the CE mark on their products. Certificates of Conformity Approval, which is called CE Certificate in the market (Module A - Internal Control of Production, Module B - EU Type Examination, Module C - Compliance with Type Based on Internal Control of Production, Module C2 - Internal Control of Production and Compliance with Type Based on Inspected Inspection of the Product at Random Intervals, Module D - Manufacturing Process Based on Type of Quality Assurance Compliance, etc.) firms can offer their products in Turkey and sold in the European market.
Which Regulations and Standards Should Be Evaluated?
* 2016/425 / EU: Personal Protective Equipment Directive
* TS EN 340: Covers performance characteristics such as ergonomics, compatibility and harmlessness for protective clothing.
* TS EN 1073-2: Covers the rules and experiments of non-ventilated protective clothing that prevents contamination against radioactive pests.
* TS EN 13982-1: It covers the performance characteristics of the clothes that protect the whole body against airborne viruses.
* TS EN 13034: It covers the performance characteristics of the clothes that provide limited protection against liquid chemical substances.
* TS EN 14126: It covers the test methods and performance features of the clothes that protect against pathogenic organisms.
* TS EN 14605: It covers the performance characteristics of the clothes that protect the body against liquid and spray chemicals.
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