Vaginal products and Condom

Compatibility test for use with condoms

Regulatory reference:	Proprietary method based on ISO 4074
Claim:	Compatible with latex condoms
Application field:	Vaginal products and lubrificants.
Description of the test:	The test evaluates the compatibility of the product with latex, polyurethane or polyisoprene condoms analyzing any variation in the mechanical resistance to traction and bursting following contact with the lubricating medical device being analyzed in comparison with appropriate controls.

Posted in Vaginal products and Condom, Compatible with latex condoms, Claim for medical devices

Biocompatibility test

Regulatory reference:	ISO 10993-10
Claim:	Biocompatible
Application field:	Finished products, textiles, solid products by eluate.
Description of the test:	Biocompatibility test: triple analysis for irritation, cytotoxicity and sensitization potential.

Posted in Vaginal products and Condom, Filter devices, shielding films and plasters, Heating and cooling products, Mucoadhesive products, Protection and barrier effect, Raw materials for medical devices, Substance-based, Surgical devices and medications, Claim for medical devices, Biocompatible

Challenge Test

Regulatory reference:	ISO 11930 for cosmetics; European Pharmacopoeia for medical devices
Claim:	Efficacy of preservatives
Application field:	Cosmetics and medical devices.
Description of the test:	Challenge test for the evaluation of the efficacy of preservative systems according to ISO guidelines (for cosmetics) and European Pharmacopoeia (for medical devices).

Posted in Vaginal products and Condom, Filter devices, shielding films and plasters, Heating and cooling products, Mucoadhesive products, Protection and barrier effect, Detergents, Raw materials for medical devices, Substance-based, Surgical devices and medications, Make up, Moisturizers, Preservative systems, Claim for cosmetics, Claim for medical devices, Efficacy of preservatives

Highlights

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

Contacts

Email:
Phone:	+39 0323 586239/496041
Address:	Via 42 Martiri, 213/B 28924 Verbania (VB) Italy