Heating and cooling products

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

Skin tolerability test under dermatological supervision

Regulatory reference:	Guidelines to Commission Regulation (EU) No 655/2013
Claim:	Dermatologically tested
Application field:	Heating and cooling medical devices and cosmetic products.
Description of the test:	Measurement at T=0 before the application and after a preset duration agreed upon with the sponsor; Temperature control using an infrared non-invasive thermometer; Evaluation of the erythemal response through skin colorimetry using a Mexameter® MX18 colorimeter (Courage-Khazaka GmbH – Germany); Evaluation by clinical experts of the general conditions of the skin and epidermal tolerability during use; Subjective evaluation through predefined questionnaire with numerical score system (visual analogical scale) and judgement of the tolerability and heat/chill feeling as perceived during the application of the product; Comparative photography with colorimetric reference captured with a 100 mm macro objective and normalization of the color with coaxial circular flash.

Posted in Heating and cooling products, Dermatologically tested, Claim for medical devices

Quantification of the titer of substances

Regulatory reference:	Regulation 1223/209
Claim:	Titer of substances and Limit of preservatives
Application field:	Preservatives, dyes, sunscreen filters.
Description of the test:	Quantification method for the measurement of the titer of substances by HPLC, UPLC, GC-MS after preparative steps.

Posted in Heating and cooling products, Mucoadhesive products, Cosmetic raw materials, Detergents, Raw materials for medical devices, Substance-based, Surgical devices and medications, Claim for cosmetics, Claim for medical devices, Titer of substances, Limit of preservatives

Stability test

Regulatory reference:	ICH or ISO
Claim:	Accelerated stability tests
Application field:	Medical devices and cosmetics.
Description of the test:	Accelerated stability test according to ICH guidelines and ISO regulatory requirements, for medical devices and cosmetics.

Posted in Filter devices, shielding films and plasters, Heating and cooling products, Mucoadhesive products, Protection and barrier effect, Accelerated stability test, Substance-based, Surgical devices and medications, Make up, Claim for cosmetics, Claim for medical devices, Accelerated stability tests

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