Technical report on masks
How to determine whether medical / protective masks are appropriate or not? Also compliant with the Medical Devices Directive / Regulation?
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.
Compliance of protective masks must be ensured by the manufacturer or distributor or 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),
- the 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 system
- 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 product quality system approval (harmonized standard EN 149: 2001 + A1: 2009) was issued,
- labeling of the product or packaging.
We are preparing a technical report.
Compliance of medicine masks must be ensured by the manufacturer or distributor or 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.