Material selection
Comparison between granules, bars, plates, filament and other implantable PEEK formats.
From selection to validation
Technical support capacity Invibio
Thermal, chemical, microscopic and mechanical analysis capabilities to support the development of PEEK devices.
Support throughout development
The support described in the document begins in the selection of the biomaterial and its form of supply, passes through the design and production process and achieves characterization, testing and technical documentation for the regulatory project.
Project support
Discussion of geometry, processing, expected performance and manufacturing requirements.
Tests and analysis
Thermal, chemical, microscopic, molecular and mechanical characterization.
Regulatory
Technical information and documentary support for compliance routes applicable to the device.
01
Microscopy and composition
3D optical microscopy supports failure analysis, surface characterization, measurements and fracture inspection. SEM with EDS allows you to observe micro and nanostructures and map the elemental composition by point, line or area.
02
Thermal and molecular analyses
CSD evaluates thermal transitions and crystallinity; TGA monitors mass variation and load content; TMA measures dimensional changes; FTIR helps identify molecular groups; GPC characterizes molecular mass distribution and macromolecular structure.
03
Mechanical tests
The document relates tensile, bending, impact and compression tests, including references to ISO 527, ISO 178, ISO 180 and ISO 604. The capabilities and equipment shall be confirmed for the applicable scope and version of the method.
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