The management of masks in the European market is divided into two main categories, personal protective masks and medical masks. Personal protective masks are mainly for industrial protection, and medical masks are mainly for hospital use
The corresponding European standard for medical masks is EN14683. The classification of the masks as shown in the figure below is divided into three categories according to BFE, respiratory impedance and splash resistance.
Classification of European medical surgical masks
According to the requirements of the medical device regulation 2017/745 / EU, mask products can be managed according to a type of device. Depending on whether the product is provided in a sterile or non-sterile state, the certification model is different.
1. Provide in a non-sterile manner
1) Preparation of technical documents
2) Provide test report (can provide melt blown cloth performance test report and non-woven fabric biological report)
3) Preparation of DOC
4) Appoint an EU authorized representative and complete the European registration
2. Provide aseptically
1) Sterilization verification
2) Establish ISO13485 system
3) Preparation of technical documents
4) Provide test reports (biological, performance, sterility and other test reports of the mask itself)
5) Announcement agency audit (currently only audited according to MDR, it is expected that there will be no NB audit in the near future)
6) Obtained CE certificate
7) Appoint an EU authorized representative and complete the European registration
From the current overall situation, if you have not obtained the CE certificate of the notified body before, it is no longer possible to apply for it temporarily, so the mask products currently exported to Europe should only provide an option in non-sterile state. However, non-sterile does not completely control the production environment. EN14683 requires no more than 30cfu / g for the initial contaminated bacteria of the product.
Protective mask The European standard for protective masks is EN149. According to the standard, masks are divided into three categories: FFP1 / FFP2 and FFP3. Classification of European protective masks Protective masks need to meet the requirements of the EU Personal Protective Equipment Directive (PPE). Protective masks are products of complex design. Exporting to Europe requires an authorized notified body to certify and issue certificates. The materials required for certification include: A) Product type test report; B) Technical document review; C) Factory quality system review.