Industry News

Applicable standards distinguish medical/non-medical masks

2020-07-02

Enterprises and individuals can be distinguished according to the country/region where the product is imported and according to the applicable standards of the product. The applicable standards and certification information of the product can be obtained from the product packaging or the manufacturer’s Obtain test report or certificate. Different standards and certification requirements apply to medical masks in different countries/regions.

 

Export to the EU

The European Union medical/non-medical masks are required to bear the CE mark, but the applicable standards are different.

Medical masks belong to Class I devices in the European Union, which are divided into Class I non-sterile and sterile. They need to be affixed with CE in accordance with the European Union Medical Device Directive 93/42/EEC (MDD) or the EU Medical Device Regulations EU2017/745 (MDR) The mark, the corresponding standard is EN14683, and the mask packaging or test report and certificate exported to the EU contain the above-mentioned contents, and can be judged as a medical mask.

It should be noted that according to the aseptic/non-sterile state of the mask, the EU adopts different conformity assessment methods. Non-sterile medical mask companies only need to make a CE self-conformity declaration, and do not need to pass the certification of the notified body. After preparing the relevant documents and test reports, you can complete the declaration of conformity yourself. Sterile medical masks must also be CE certified by an authorized notified body.

Non-medical masks exported to the EU are not medical devices, but they must meet the requirements of the EU Personal Protection Equipment Regulations EU2016/425 (PPE). CE certification and certification are issued by an authorized notified body. The corresponding standard is EN149.