MASKS
We are among the few Italian Notified Bodies certyfing FFP2 and FFP3 filtering half masks to protect against particles in accordance with the harmonized standard EN 149
THE HARMONIZED STANDARD FOR PPE MASKS FFP2 AND FFP3
EN 149
Respiratory protective devices filtering half masks to protect against particles – Requirements, testing, marking
Risk Categories of PPE
CATEGORY 3very serious consequences such as death or irreversible damage to health (e.g., extreme atmospheric conditions, high voltage, hazardous substances and mixtures).
In addition to the EU type conformity assessment procedure (Module B), one of the following procedures must be requested: type conformity based on internal production control combined with product testing under official control carried out at random intervals (Module C2) as per Annex VII of Regulation (EU) 2016/425, or type conformity based on production process quality assurance (Module D) as per Annex VIII of Regulation (EU) 2016/425.
Certification Process
Before applying for certification:
- Ensure all necessary tests have been performed according to current standards.
- Prepare the required technical documentation: technical file and user’s
For Category 3 PPE, in addition to the EU type conformity assessment Module B, apply for one of the following procedures:
- type conformity based on internal production control combined with product testing under official control carried out at random intervals (Module C2) as per Annex VII of Regulation (EU) 2016/425
- type conformity based on production process quality assurance (Module D) as per Annex VIII of Regulation (EU) 2016/425.
Certification validity and document storage
Keep the EU declaration of conformity and technical documentation for 10 years from the date the PPE is placed on the market.
The EU Type Certificate Module B is valid for a maximum of 5 years from the date of issue, unless the referenced harmonized standard is revised.
Module C2 and Module D are subject to annual surveillance.
FOR MORE INFORMATION
Contact us for:
- Contact us to verify the validity of our EU Certificates
- o learn about the financial means supporting our activities.
USEFUL INFORMATION
COMPLAINTS AND APPEALS REPORTS
fill out the M33 form and send it to qualita@cimac.it