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Following the whole COVID-19 global context, EQUILIBRIUM Laboratory has worked together with its clients at an international level, so that we can give a timely response to companies and to the population in general. Always with a view to impartiality in results and speed in services.
It is crucial to establish the purpose of your product in order to classify it.
After classifying, and before placing their products on the market, manufacturers and distributors must follow these guidelines:
Product |
|
Product Textile |
Mask |
Medical device |
-Clinical mask; |
EPI |
- Respiratory protective device |
Biocides |
Biocides/ |
authority |
|
Product Textile |
Authority |
Medical device |
Competent authority |
EPI |
Supervisory Authority ASAE |
Biocidas |
authority |
Referential |
|
Product Textile |
CWA 17553:2020 (for |
Medical Device |
Directive 93/42/CEE |
EPI |
Regulation |
Biocides |
/ |
Each area of performance is based on the Legal and Normative framework, being important the harmonization of characteristics and test methods at the level:
– Minimum performance requirements
– Specifications of the appropriate test methods
– Recommendations for use
In the specific case of community face covers, the document CWA 17553:2020, provides a support for producers. Specific changes and recommendations / guidelines by state and supervisory bodies of each country are safeguarded.
Their design according to accepted best practices and production quality control remains the responsibility of the producer. The producer may need to use a laboratory to verify the required performance. The community face cover specified in this document is neither a medical device (MD) under Directive 93/42/CEE or Regulation (EU) 2017/745 nor a personal protective equipment (PPE) under Regulation (EU) 2016/425. The producer may need to use a laboratory to verify the required performance. The community face cover specified in this document is not a medical device (MD) within the scope of Directive 93/42/CEE or Regulation (EU) 2017/745, nor is it a personal protective equipment (PPE) within the scope of Regulation (EU) 2016/425.
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