Mask technical report statement
How to determine whether medical / protective masks are appropriate or not? Are they compliant with the Medical Devices Directive / Regulation?
30. 03. 2020
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30. 03. 2020
Choosing the right mask is a daunting task.
For the purpose of expert review of the documentation of medical or protective masks, we prepare a Technical Report with detailed descriptions of all established facts.
Compliancy for protective masks has to ensure the manufacturer / distributor / importer
- Declarations of conformity.
- instructions for proper storage, use and disposal,
- quality management system – for the purpose of production (ISO 9001: 2015),
- EU type-examination certificate (Regulation – Module B) issued by a Notified Body (CE 0000),
- test certificate on the basis of which the EU-type examination certificate (harmonized standard EN 149: 2001 + A1: 2009) was issued,
- certificate of approval of the product quality system2,
- Conformity to type based on internal control of production and controlled tests of products at random intervals (Regulation – Module C2) issued by the Notified Body (CE 0000),
- Conformity to type based on production quality assurance (Regulation – Module D) issued by a Notified Body (CE 0000),
test certificate on the basis of which the Certificate of approval of the product quality system (harmonized standard EN 149: 2001 + A1: 2009) was issued, - labeling of the product or packaging.
Compliancy for medical masks has to ensure the manufacturer / distributor / importer
- Declarations of conformity,
- instructions for proper storage, use and disposal,
- quality management system – for production (ISO 13485: 2016),
- test certificates (harmonized standard EN 14683: 2019 + AC: 2019),
- labeling of the product or packaging.