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. |
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. |
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). |