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How much is the cost of CE certification of respirator

1、 Why do masks need CE certificate for export to Europe
For many products, CE certification is a necessary certificate to enter the European market. Most popular CE certified products are masks, many new ones
In order to respond to the needs of European buyers, manufacturers are actively applying for CE certification. But recently, CE certificates issued by various organizations let you
It is difficult to distinguish and use correctly. I hope that through the analysis of this article, we can have a clear understanding of this.
2、 What kind of CE certificate do civil masks need to get into Europe
Just as the management and control of respirators in China is divided into medical and civil use, the management and control of respirators in Europe is also divided into the following two categories:
Medical masks need to meet the requirements of Medical Devices Directive, while civil masks need to meet the requirements of personal protection directive (EU) 2016 / 425). Civil port
The mask shall apply for CE certificate, and the mask shall be made according to the personal protection ce-ppe instruction and standard en149. The announcement with corresponding product range qualification is required
Only when CE certificate is issued by the organization can the European requirements be met.
3、 Test items of en149 standard for CE certification of civil masks:
Civil masks are used to filter the air entering the mouth and nose, so as to prevent harmful gases, smells and droplets from entering and leaving the mouth and nose of the wearer. main
It is divided into cotton mask, non-woven mask, polymer mask, active carbon powder filter mask and active carbon fiber blanket mask.
1. Appearance 2. Material 3. Resistance test 4. Headband 5. Exhalation valve 6. Pretreatment 7. Respiratory resistance 8. Air leakage coefficient 9. Carbon dioxide concentration 10. Real
International wearing
EU en149: 2001 test standard:
Respiratory protective devices - filter half masks for particle protection - requirements, testing and marking
Ffp1: low filtering effect 80%
FFP2: low filtering effect 94%
FFP3: low filtration effect 97%
1. High allowable dust penetration value: air flow at 95 LPM
2. Initial test allows delta P to breathe resistance
4、 CE certification process of respirator:
Step 1: provide product information, and do it by series
1. Fill in the application form
2. Application company information form
3. Provide product data and send samples
Step 2: Quotation
Determine the test standard, test time and corresponding cost according to the data provided by the engineer;
Step 3: payment
After confirming the offer, the applicant shall sign the filing application form and service agreement and pay the payment
Step 4: Test
The laboratory shall carry out a complete set of tests on the applied products according to the relevant EU test standards
Step 5: pass the test and complete the report
Step 6: complete the project and issue CE certificate
5、 Issuing authority
Issued by: Italian ECM, Announcement No. 1282
1. Headquartered in Italy, it is a global multinational enterprise with 56 offices around the world and more than 30000 registered customers;
2. Asia Pacific General Office, providing customers with fast, professional and trustworthy services;