Substance-based

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 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 Fabrics, plastics and polymer patches, Heating and cooling products, Mucoadhesive products, Protection and barrier effect, 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 Condom and vaginal products, Fabrics, plastics and polymer patches, 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 Condom and vaginal products, Fabrics, plastics and polymer patches, Heating and cooling products, Mucoadhesive products, Protection and barrier effect, Raw materials for medical devices, Detergents, Substance-based, Surgical devices and medications, Make up, Moisturizers, Preservative systems, Claim for cosmetics, Claim for medical devices, Efficacy of preservatives

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