Surgical Face Mask CE Marking - Operon strategist

 

Surgical Face Mask CE Marking and EU Registration is mandatory for marketing the medical device in the European region. The present European Medical Device Directive (MDD) has to be followed with regard to Class 1 medical devices. 

Face masks become a symbol in each pandemic period. It is very important to wear a mask for a viral enemy that is unclear where it will come from and is not visible even if it is not hidden. Although people sometimes use a scarf wrapped around their face or colorful homemade textiles that cover the mouth and nose, it is best to use masks or, more rarely, N95 masks for effective and healthy protection.

• As CE mark consultants for medical devices we’ll help you for the process of making a defined technical file with all the product details.
• We will help you in meeting European submission standards that state the product offered is in compliance with the exact requirements of European safety.

The classification of masks is mainly based on the results of the following tests:

• Bacterial filtration efficiency test
• Breathability (delta P) test
• Splash resistance (synthetic blood) test
• Microbial cleaning test
• Biocompatibility test

The basic standard that must be complied with in order to put Surgical Face Mask CE Marking is the TS EN 149 standard (Respiratory protective devices – Half masks with filters for protection against particles – Properties, experiments and marking standard). This standard describes the minimum conditions for half masks with filters, respiratory equipment used for protection against particles that cannot be removed from the environment.

Surgical Face Mask CE Marking 

Surgical Face Mask CE Marking as a medical device is theoretically possible but there is no standard for this and in the absence of a widely agreed performance benchmark the rules for CE marking medical devices, which require the manufacturer to have clear evidence that the device provides a medical benefit in response to one or more specific illness or disability, actually make it likely that it will cost more and take longer than the Notified Body procedure for PPE.

CE marking can now be placed on surgical masks that pass these tests under the responsibility of the manufacturer. Surgical Face Mask CE Marking services are also provided to our businesses within the scope of certification services.

Surgical Face Mask CE Marking is approved for safety, health and environmental protection standards. After tests performed in advanced laboratories, masks are classified as N95, N99 and N100 according to their level of efficiency, and CE marking is put on it by rating it as FFP1, FFP2 or FFP3.

Read More - Surgical Face Mask CE Marking

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Contact details –

Phone  no -  93702 83428

Mail id – enquiry@operonstrategist.com

If  You Want Medical Devices Services Consultation For Following.

1. Medical Device Consulting 
2. cdsco registration 
3. FDA 510k Clearance 
4. ce mark medical device 
5. CDSCO Manufacturing License 
6. CDSCO import license 
7. TURNKEY PROJECT CONSULTANT 
8. medical device manufacturing 
9. iso 15378 certification 
10. 21 cfr part 210 and 211 
11. ISO 13485 Medical Device Consultant 
12. Primary Packaging Turnkey Project Consultant 
13. Clean Room Design Consultant 
14. manufacturing site conceptualization 
15. Market Analysis and feasibility for Medical Devices 
16. manufacturing plant layout design 
17. medical device design and development 
18. DMF file submission guideline 
19. 21 cfr part 820 
20. qms certification services 
21. capa management 
22. design control requirements 
23. medical device process validation 
24. combination product 
25. continuous improvement program 
26. Medical Device Compliance & Regulatory Services 
27. Cdsco India authorized agent for medical device