Views:334 Author:Site Editor Publish Time: 2021-01-18 Origin:Site
The management of masks in the European market is divided into two main types, personal protective masks and medical masks. Personal protective masks are mainly used for industrial protection, and medical masks are mainly used in hospitals. This two kinds of masks are required to be produced by different mask making machines, such as medical mask making machines and ultrasonic mask making machines.
The corresponding European standard of medical masks is EN14683, which classifies masks into three types according to BFE, respiratory impedance and splash resistance. In accordance with the requirements of the Medical Device Regulation 2017/745/EU, masks can be managed as I class devices. Depending on whether the product is provided in a sterile or non-sterile state, the certification model is different.
1) Medical Masks Are Provided in a Non-sterile Way
A. Preparation of technical documents.
Provide test report. (It can provide melt blown cloth performance test report and non-woven fabric biological report)
B. Prepare DOC.
C. Designate an EU authorized representative and complete European registration.
2) Medical Masks Are Provided in a Sterile Way
A. Sterilization verification.
B. Establish the ISO13485 system.
C. Preparation of technical documents.
D. Provide test report, (test report on biology, performance, sterility, etc.)
E. Announcement agency review
F. Obtain CE certificate and complete European registration.
From the current overall situation, if you have not obtained the CE certificate before, it is no longer possible to apply temporarily. Therefore, masks currently exported to Europe should only have the option of providing in non-sterile way. However, non-sterile does not mean that it does not control the production environment completely. EN14683 requires no more than 30cfu/g for the initial contamination of the product.
The European standard for protective masks is EN149. According to the standard, masks are divided into three types: FFP1/FFP2 and FFP3.
Protective masks need to meet the requirements of the EU Personal Protective Equipment Directive (PPE), and protective masks are products with complex designs. Masks exported to Europe needs to be certified and issued by an authorized agency. The items required for certification include:
1) Type test report of the product
2) Review of technical documents
3) Factory quality system review
4) Announcement agency review
5) Certificate issue
The mask needs to obtain the EU type certification (Module B) + random product inspection (Module C2) or quality control of the production process (Module D). As a European announcement agency, DEKRA reminds all manufacturers that when exporting protective masks to Europe, they must choose a compliant announcement agency with complete qualifications to avoid unnecessary losses after export.
DEKRA, as Germany’s largest inspection, testing and certification agency, is also the EU Notified Body (NB 0158). For protective (PPE) masks exported to Germany, DEKRA and IFA jointly proposed to the German Security Certification Technology Center (ZLS) the temporary rapid testing and conformity declaration process, and it was approved by ZLS on March 20.
This process is based on the EN 149:2001+A1:2009 standard for rapid testing of personal protective masks, and products that pass the test will obtain a conformity verification. The entire process is completed in 1-2 weeks under normal circumstances. At present, only DEKRA and IFA are authorized by the German Security Certification Technology Center to perform rapid testing in accordance with this process.
If you wish that masks are better exported to Europe, you need to choose a more professional and suitable automatic mask making machine. When choosing a fully automatic mask making machine, you must have a comprehensive understanding of the face mask making machine.
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