Raw materials for medical devices

H295R Steroidogenesis Assay – OECD 456

Regulatory reference: According to OECD 456.
Claim: No endocrin 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, No endocrin disruption, Raw materials for medical devices, Claim for cosmetics, Claim for medical devices

Mucoadhesion test

Regulatory reference: Proprietary method
Claim: Mucoadhesive effect
Application field: Finished products for direct application on external mucosae.
Description of the test: Gravimetric analysis of the adhesion of a product on a layer of mucin against the same product on an untreated plane. Detachment kinetics in terms of percentage of adhesion against a non-adhesive control.
Posted in Mucoadhesive products, Raw materials for medical devices, Surgical devices and medications, Mucoadhesive effect, Claim for medical devices

Mucoadhesion test: gravimetric variant using the dry weight of the product

Regulatory reference: Proprietary method
Claim: Mucoadhesive effect
Application field: Finished products for direct application on external mucosae.
Description of the test: Analysis of the resistance to washing off with and without a basal layer of mucin. Determination of the percentage of resistance against the same product on substrate without mucin.
Posted in Mucoadhesive products, Raw materials for medical devices, Surgical devices and medications, Mucoadhesive effect, Claim for medical devices

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 Fabrics, plastics and polymer patches, 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

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

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

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, Detergents, Raw materials for medical devices, Substance-based, Surgical devices and medications, Make up, Moisturizers, Claim for cosmetics, Preservative systems, Claim for medical devices, Efficacy of preservatives