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. |
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. |
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. |
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: | 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). |