Fabrics, plastics and polymer patches

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

UV protection of textile products (UPF)

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.
Posted in Fabrics, plastics and polymer patches, UV protection factor for textiles (UPF), Claim for medical devices

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, 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