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Raw materials 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

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

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