Characterization of your medical devices according to ISO 10993-19
Would you like to perform a medical device characterization according to ISO 10993-19?
Physicochemical, morphological, and topographical characterization is an essential step in the biological evaluation of medical devices.
ISO 10993-19 analysis identifies surface, structural, and compositional properties that may influence the device’s biocompatibility.
Our ISO 10993-19 analysis
Depending on your needs, the tests performed may include:
Composition and impurity analysis
Multi-scale morphological analysis
Surface and roughness characterization
Comparative studies between batches or materials
Our analytical techniques for PMT characterization according to ISO 10993-19
At the FILAB laboratory, ISO 10993-19 characterization is based on a multi-technique approach tailored to the nature of the device and its clinical use:
- physicochemical analyses of materials by FTIR, TGA, DSC, ICP-AES
- surface and topographical characterization by AFM
- morphological analyses at different scales by SEM-EDX
- identification of surface treatments or coatings by SEM-EDX, XPS, ToF-SIMS
- study of the surface condition and homogeneity of materials by Raman microscopy
Analytical protocols are defined according to the device, its manufacturing process and regulatory requirements.
FILAB laboratory supports you with ISO 10993-19 analysis of your medical devices
PMT characterization (physicochemical, morphological, and topographical) in a nutshell...
ISO 10993-19 provides a set of parameters and associated analytical methods for the PMT characterization (physicochemical, morphological, and topographical) of medical devices. These PMT parameters play an important role in the biocompatibility and clinical effectiveness of medical devices.
What is ISO 10993-19?
The ISO 10993-19 standard is part of the ISO 10993 series dedicated to the biological evaluation of medical devices.
It defines the principles and methods for PMT characterization (physicochemical, morphological and topographical) of materials and devices, before or in addition to biological testing.
This characterization provides an in-depth understanding of the material, its surface and its potential behavior in contact with the body.
PMT characterization (physicochemical, morphological and topographical) in a nutshell
PMT characterization aims to precisely describe:
- the chemical nature of the material
- the structure and morphology of the device
- surface properties that may influence biological interactions
What is the scope of ISO 10993-19?
ISO 10993-19 applies to all medical devices, regardless of their class, when their physicochemical or surface properties may affect biological safety. It applies in particular to:
polymer, metal, ceramic, or composite materials
devices with surface treatments, coatings, or specific texturing
implantable and non-implantable devices
The rise of nano-characterization according to ISO 10993-19 and -22 standards
Discover our press articleFurther information
Our human scale, ongoing investments, and knowledge of the medical device sector guarantee our clients reliable results, fast processing of requests, and tailored support to meet their needs.
Our FAQ
ISO 10993-19 covers, in particular:
- the chemical composition of materials
- surface morphology and topography
- physicochemical properties relevant to biological evaluation
- the identification of parameters that may influence material–organ interactions
- in vivo or in vitro biological testing
- the toxicological assessment of substances (addressed in other parts of ISO 10993)
- clinical performance testing
To request a quote, you can contact our teams via our contact form, by phone or by email.
Simply send us your requirements (material type, requested analysis, applicable standard, urgency, number of samples, etc.). We will then send you a personalized technical and financial proposal within 24–48 hours.
Turnaround times vary depending on the nature of the analysis and the complexity of the expert assessment project.
FILAB nevertheless commits to providing fast turnaround times tailored to your industrial constraints and urgent requirements.
