Claim for medical devices

Percutaneous absorption test

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

Posted in Protection and barrier effect, Substance-based, Claim for medical devices, Evaluation of transcutaneous absorption

Quantification of trace substances and impurities

Regulatory reference:	UE Regulation
Claim:	Titer of substances
Application field:	Cosmetics and medical devices.
Description of the test:	Analysis of trace substances, residues and impurities for quality control purposes through UPLC or GC-MS. Includes sample preparation.

Posted in Filter devices, shielding films and plasters, Cosmetic raw materials, Raw materials for medical devices, Surgical devices and medications, Claim for cosmetics, Claim for medical devices, Titer of substances

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

UV protection of textile products (UPF)

Regulatory reference:	BS EN 13758-1:2001
Claim:	UV protection factor for textiles (UPF)
Application field:	Textile fabrics, clothes, bandages.
Description of the test:	Evaluation of the protection in the UV spectrum granted by textile protective items or similar products through analysis of the absorbance.

Posted in Filter devices, shielding films and plasters, UV protection factor for textiles (UPF), Claim for medical devices

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

Compatibility test for use with condoms

Regulatory reference:	ISO 19671:2018
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

Ames test

Regulatory reference:	OECD 471
Claim:	Non mutagenic
Application field:	Raw ingredients for medical devices or cosmetics.
Description of the test:	Analysis of genotoxicity of a substance according to OECD 471.

Posted in Cosmetic raw materials, Raw materials for medical devices, Claim for cosmetics, Claim for medical devices, Non mutagenic

Evaluation of bacterial adhesion on mammal cells

Regulatory reference:	Proprietary method
Claim:	Inhibition of bacterial adhesion
Application field:	Medical devices design to inhibit bacterial adhesion.
Description of the test:	Evaluation of bacterial adhesion on mammal cells, performed on the CACO-2 cell line.

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

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