Protection and barrier effect

Determination of breathability (differential pressure) on surgical masks

Regulatory reference:	UNI EN 14683:2019.
Claim:	Determination of breathability
Application field:	Raw materials and finished products.
Description of the test:	Determination of the differential pressure is an indicator of the “breathability” of the mask. Air permeability is measured by determining the pressure difference across the mask under specific conditions of airflow, temperature and humidity.

Posted in Filter devices, shielding films and plasters, Protection and barrier effect, Raw materials for medical devices, Surgical devices and medications, Determination of breathability, Claim for medical devices

In vitro skin irritation test according to ISO 10993-23:2021

Regulatory reference:	ISO 10993-23:2021.
Claim:	Biocompatible
Application field:	Raw materials and finished products.
Description of the test:	In vitro skin irritation test for solid medical devices according to ISO 10993-23:2021.

Posted in Filter devices, shielding films and plasters, Protection and barrier effect, Raw materials for medical devices, Surgical devices and medications, Claim for medical devices, Biocompatible

Bioburden: Microbiological cleanliness analysis according to UNI EN ISO 11737-1:2018 and UNI EN 14683:2019

Regulatory reference:	UNI EN ISO 11737-1:2018 and UNI EN 14683:2019.
Claim:	Determination of bacterial charge
Application field:	Raw materials and finished products.
Description of the test:	The Bioburden analysis is designed to determine the microbiological cleanliness of medical face masks in order to evaluate their suitability for medical usage.

Posted in Filter devices, shielding films and plasters, Protection and barrier effect, Raw materials for medical devices, Surgical devices and medications, Determination of bacterial charge, Claim for medical devices

Bacterial Filtration Efficacy (BFE) testing according to ISO 14683

Regulatory reference:	ISO 14683:2019 (B).
Claim:	BFE (Bacterial Filtration Efficiency)
Application field:	Raw materials and finished products.
Description of the test:	Bacterial Filtration Efficacy (BFE) testing according to EN 14683:2019 (B) through Andersen six stage viable impactor. The analysis is performed on textile samples for the production of surgical masks or on finished surgical masks.

Posted in Filter devices, shielding films and plasters, Protection and barrier effect, Raw materials for medical devices, Surgical devices and medications, BFE (Bacterial Filtration Efficiency), Claim for medical devices

Evaluation of barrier effects on 3D reconstructed human epidermis

Regulatory reference:	Proprietary method
Claim:	Protects and repairs the cutaneous barrier
Application field:	Topical products.
Description of the test:	Evaluation on 3D in vitro epidermis of the efficacy of a product in protecting against acids, alkalis or solvents.

Posted in Protection and barrier effect, Protects and repairs the cutaneous barrier, Claim for medical devices

Evaluation of barrier effects on 3D reconstructed human epidermis and analysis of inflammatory cytokines

Regulatory reference:	Proprietary method
Claim:	Protects and repairs the cutaneous barrier
Application field:	Topical products.
Description of the test:	Evaluation of the protective efficacy against acids, alkalis or solvents on in vitro 3D human epidermis, paired with evaluation of the protection against pro-inflammatory substances.

Posted in Protection and barrier effect, Protects and repairs the cutaneous barrier, Claim for medical devices

Barrier effect test on 3D reconstructed skin by analysis of the transcutaneous passage of caffeine

Regulatory reference:	Proprietary method
Claim:	Barrier effect
Application field:	Solutions or finished products.
Description of the test:	Quantification by HPLC of the amount of caffeine permeating the skin barrier of in vitro 3D skin in Franz’s cells, compared to the total titer of the same substance in the applied product.

Posted in Barrier effect, Protection and barrier effect, Claim for medical devices

Barrier effect test on 3D reconstructed skin by analysis of the transcutaneous passage of testosterone

Regulatory reference:	Proprietary method
Claim:	Barrier effect
Application field:	Solutions or finished products.
Description of the test:	Quantification by HPLC of the amount of testosterone permeating the skin barrier of in vitro 3D skin in Franz’s cells, compared to the total titer of the same substance in the applied product.

Posted in Barrier effect, Protection and barrier effect, Claim for medical devices

Protection and barrier effect test on oral epithelium with analysis of IL1-Alpha expression

Regulatory reference:	Proprietary method
Claim:	Protects and repairs the cutaneous barrier
Application field:	Topycal products.
Description of the test:	Measurement of inhibitory efficacy of an active ingredient or finished product against the adhesion of Staphylococcus aureus to epithelial cells.

Posted in Protection and barrier effect, Protects and repairs the cutaneous barrier, Claim for medical devices

Barrier effect test against microbial strains

Regulatory reference:	Proprietary method
Claim:	Inhibition of bacterial adhesion
Application field:	Raw ingredients or finished products.
Description of the test:	Measurement of inhibitory efficacy of an active ingredient or finished product against the adhesion of Staphylococcus aureus to epithelial cells.

Posted in Protection and barrier effect, Inhibition of bacterial adhesion, Claim for medical devices