Claim for medical devices

Clinical tests with high resolution infrared camera using healthy volunteers

Regulatory reference:	Proprietary method
Claim:	Infrared thermography
Application field:	Raw materials and finished products.
Description of the test:	Simulation in conditions of long or short term use of the medical device. The test includes mathematical processing of physical data in order to have a quantitative result of the change in the temperature of the skin treated by the product over time.

Posted in Heating and cooling products, Infrared thermography, Claim for medical devices

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

Determination of antiviral activity of textile products according to ISO 18184:2019 (E)

Regulatory reference:	ISO 18184:2019 (E).
Claim:	Antiviral activity
Application field:	Raw materials and finished products.
Description of the test:	The test can be performed on textiles (wool, fibers, spun materials, bundles, knitwear fabrics). Tested products can be used in hospitals and healthcare facilities, or as upholstery materials on transports. The virus strands used in the test are “Type A flu” and “Feline carcinovirus”. Other virus strands can be tested upon requests, following a feasibility study.

Posted in Filter devices, shielding films and plasters, Antiviral activity, Claim for medical devices

Antiviral activity on plastics and other non-porous surfaces according to ISO 21702:2019 (E)

Regulatory reference:	ISO 21702:2019 (E).
Claim:	Antiviral activity
Application field:	Raw materials and finished products.
Description of the test:	The test can be performed on plastics, upholstery materials, ceramics, natural or artificial leather, stainless steel, rubbers. The virus strands used in the test are “Type A flu” and “Feline carcinovirus”. Other virus strands can be tested upon requests, following a feasibility study.

Posted in Filter devices, shielding films and plasters, Antiviral activity, Claim for medical devices

LAL (Lysate of Limulus Amaebocytes) test

Regulatory reference:	USP85.
Claim:	Absence of bacterial endotoxins
Application field:	Medical devices: raw ingredients and finished products.
Description of the test:	Lysate of limulus amaebocytes (LAL) is an acqueous extract obtained by Limulus polyphemus amaebocytes. The LAL reacts strongly to endotoxins in Gram-negative bacterial membranes (lypopolysacchartides), resulting in coagulation. This property is exploited in the LAL test to detect endotoxins.

Posted in Raw materials for medical devices, Absence of bacterial endotoxins, Claim for medical devices

H295R Steroidogenesis Assay – OECD 456

Regulatory reference:	According to OECD 456.
Claim:	No endocrine disruption
Application field:	Raw ingredients and finished products.
Description of the test:	The purpose of the test is identifying substances that interfere with 17-ß estradiol and testosterone production.

Posted in Cosmetic raw materials, Raw materials for medical devices, No endocrine disruption, Claim for cosmetics, 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