Products and Packaging Validation

Chemical characterization of materials

A Testing method has been established following Standard ISO 10993-13 for ʺBiological evaluation of medical devicesʺ.

Rescoll can help you to select appropriate analytical methods for your medical device through a literature study or using our expediencies…

• DMTA : Dynamic mechanical thermal analysis
• DSC : Differential scanning calorimetry
• EDX-SEM : Electron dispersal X-ray analysis – scanning electron microscopy
• GC : Gas chromatography
• GC-MS : Gas chromatography – Mass spectroscopy
• GPC : Gel permeation chromatography
• HPLC : High performance liquid chromatography
• FTIR : Fourier transform infra red
• ICP : Inductively coupled plasma
• IR : Infrared
• NMR : Nuclear magnetic resonance
• UV Ultraviolet

These analytical methods are useful and available at RESCOLL  to obtain quantitative and/or qualitative information on product in order to establish the material equivalence compared to a clinically established original product or to characterize a new product.