The ANSM (French National Agency for the Safety of Medicines and Health Products) recognizes the conformity of the measurements carried out on the equipment and following the operating protocol proposed by the Icare Group. It becomes the first European laboratory to meet all the conditions for the certification of surgical masks.
For 25 years, the Icare Group has been specialised in the guarantee of the safety of health products, in compliance with regulations. With this experience, it has been able to meet the growing demand from its partners and customers for compliance checks on medical devices related to the health crisis.
Since the beginning of April, in Saint-Beauzire, the Group has been working on a set of processes to test and analyze the quality and conformity of products and manufacturing processes.
Thus, Icare has implemented a bacterial filtration efficiency measuring bench and a breathability measuring equipment in accordance with Annexes B and C of the NF EN 14683-2019 standard.
Controlled tests (standard NF EN 14683+AC – 2019 and its appendices):
– In vitro measurement of bacterial filtration efficiency (BFE) on viable Staphylococcus aureus (Staphylococcus aureus) type particles. Assembled at Icare, a device measures the amount of microorganisms that pass through the mask, thus its effectiveness.
– Breathability measurement (differential pressure). The specific and standardized device was manufactured according to a very precise specifications developed by Icare.The idea is to blow an air flow in an airtight chamber. A mask is placed in its center which cuts the chamber into two parts. “The breathability measurement is determined by calculating the pressure difference between the two parts.”
– Evaluation of microbial cleanliness.The tests are carried out according to a process perfectly controlled by Icare. This activity constitutes its core business on behalf of medical device manufacturing and for which Icare has been COFRAC accredited since 1995 on the basis of NF EN ISO 17025 – 2017.
– 3 biocompatibility tests – ISO 10993 standard – are performed by the Group: cytotoxicity (COFRAC accreditation); skin irritation and sensitization (based on the Principles of Good Laboratory Practice (BPL2)).
A 360° perspective:
The ANSM considers, after the evaluation and discussions with the Icare Group, that a result of bacterial filtration efficiency or breathability rendered using the equipment and according to the proposed protocol, may be used by a mask manufacturer to demonstrate compliance with the CE marking.
This aknowledgment confirms the strong will of Christian Poinsot, President and Scientific Director and Séverine Itier, CEO : commitment, quality and partners support on throughout their projects, from the idea to the release.
- Different kind of masks that can be tested:
Respiratory Protection Mask (FFP): protects the mask wearer from inhaling airborne particles, and larger droplets that may contain infectious agents.
Surgical-type mask: By avoiding the projection of droplets emitted by the wearer of the mask, it limits the contamination of the outside environment and other people.
Barrier mask: These masks made out of material, with guaranteed filtration, mostly washable and reusable.They are easily recognizable.They have to be used outside the health care system.
- Laboratory Good Practices
The Laboratory Good Practice (BPL – in French) insure the quality of the organization and operation of laboratories (referred to as “test facilities”) conducting non-clinical chemical safety trials.
The purpose of BPL is to ensure the quality, reproducibility and integrity of data generated for regulatory purposes.
Source : https://www.ansm.sante.fr/