Mask Testing and Mask CE Certification

According to the Personal Protective Equipment Regulation (EU) 2016/425, dust masks are classified as Category III products and must be tested and certified by a Notified Body and an accredited laboratory. The relevant EN 149+A1 standard for respiratory protective devices—filtering half masks for protection against particles—is tested in European Union-accredited partner test laboratories. Following the submission of a technical file prepared in accordance with Annex III of the 2016/425/EU Personal Protective Equipment Regulation and a test report conducted in accordance with the EN 149+A1 standard to the authorized body, the company is eligible to obtain the certificate. The certificate is valid for five (5) years. According to the Medical Devices Regulation, Surgical Intervention Masks are classified as Class I. Surgical masks are divided into three classes: Type I, Type II, and Type IIR. Type I is suitable for patients, while Type II and Type IIR are suitable for healthcare professionals. The following tests are conducted in European Union-accredited partner testing laboratories in accordance with the EN 14683 Surgical Masks standard for the mask class specified in the request for testing and analysis.

• *Bacterial Filtration
• *Differential Pressure
• *Synthetic Blood Penetration Test (Only for TYPE II R)
• *Microbiological Cleanliness (Bioburden)

TESTPLUS is the authorized representative in Turkey of CIS INSITUT d.o.o., the European Union-approved body for testing and AT type examination of FFP2 and FFP3 masks, registered under number 2890.

For technical details, processes, and pricing related to FFP2 and FFP3 mask testing, annual inspections, CE certification, and EC Type Approval, please contact TESTPLUS Technical Experts.