Do you know the EU en14683 standard of masks
The European standard of medical mask is en14683 (medical face masks requirements and test methods). According to this standard, medical mask
can be divided into three categories: type lA / type II / type IIR. Type Ia is used for patients and other people during the epidemic, and type II and type IIR are used for medical staff.
The previous version is BS EN 14683:2014 and has been replaced by the latest version of BS EN 14683:2019. One of the most important changes of 2019 version is the pressure difference. The pressure difference of type Ⅰ, type Ⅱ and type Ⅱ r increased from 29.4, 29.4 and 49.0 PA / cm2 of 2014 version to 40, 40 and 60 PA / cm2 respectively. Type Ⅱ and type Ⅱ R are medical standards.
Masks belong to class I devices in the European Union, which are divided into class I non sterile and sterile devices. The information submitted when applying for certification is not the same.
1. Non sterile mask (only available at this stage)
1) Preparation of technical documents
2) Provide test reports (e.g. performance test reports of melt blown fabrics and biological reports of non-woven fabrics)
3) Provide declaration of conformity
4) Appointed EU authorized representative to complete European registration
Estimated approval time: 2-3 months
2. Sterile mask (it is very difficult to implement the new MDR at this stage)
1) Sterilization confirmation
2) ISO13485 system certification
3) Preparation of technical documents
4) Provide test reports (biology, performance, sterility, etc.)
5) Review by the announcement Agency (at present, almost no announcement agency is willing to receive orders)
6) Obtain CE certificate
7) Appointed EU authorized representative to complete European registrationm