CE marking is a certification application that started in European Union (EU) countries. CE marked products can be used and sold without any restrictions within the European Union. Products bearing CE mark have proven to meet all health, safety and environmental requirements. However, now it has become a generally accepted practice all over the world.
All personal protective equipment like dust masks, work shoes, work gloves and other PPE must be certified in accordance with CE criteria. The users of the products bearing this mark, are assured that the product is safe and provides strong protection. The CE mark on the device and equipment used in the medical field contributes a separate safety and reliability. Surgical masks are also included in this. The fundamental use of a surgical mask is to prevent the biological particles that will spread through the mask from the wearer of the respiratory tract into the working environment and to other people or patient.
In order to put CE mark on surgical masks, the main standard that needs to be complied with is the TS EN 149 standard (Respiratory protective devices - Half masks with filters for protection against particles - Properties, experiments and marking standard). This standard states the minimum conditions for half masks with filters, respiratory equipment used for protection against particles that cannot be removed from the environment.
Surgical masks that conform to EN 149 should fit tightly on the face and have a sealing between the mask and the face. If the masks are designed as such, breathable air does not escape through the mask wall and passes through filter. This is the reason for why it is important for surgical masks to pass the conformity test.
Surgical masks of type N95 (FFP3) particle filter fall under the third category within the scope of PPE and are masks that meet the standard requirements. Additionally, they must meet the resistance tests against splashes of blood or other infectious liquids. Surgical masks are mainly used in operating rooms.
Only those surgical masks that pass these tests under the responsibility of the manufacturer can bear the CE mark and get CE Certification.
Eurotech Assessment and Certification Services Pvt. Ltd. provides CE Mark Certification for all classes of Medical Devices. Within the scope of our certification services, we also provide CE Certification for surgical masks. Our Certification Team of experts help you in meeting all the essential requirements of Medical Devices Directive of the European Union. We not only provide Certification but also provide testing services for your medical device through our sister concern.
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