Products and Packaging Validation

Morphological and Topographical analysis of materials

Physico-chemical, Morphological and Topographical characterization of materials. Testing method has been established following Standard ISO 10993-19 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…

• AES : Auger Electron Spectroscopy including scanning tunneling auger
• BET : Brunauer-Emmett-Teller, a porosity measurement methodology
• DMTA : Dynamic Mechanical Thermal Analysis
• DSC : Differential Scanning Calorimetry
• EPMA : Electron Probe Microanalyser
• ESC : Equilibrium Solvent Content
• EWC: Equilibrium Water Content
• EDX-SEM : Energy Dispersive X-ray Analysis — Scanning Electron Microscopy
• FTIR : Fourier Transform Infra Red (spectroscopy) including microscopy, imaging and diffuse reflectance
• FTIR-ATR : Fourier Transform Infra Red (spectroscopy) -— Attenuated Total Reflectance (multiple internal reflectance)
• IR : Infra Red (spectroscopy)
• OM : Optical Microscopy including polarized light and phase contrast microscopy

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