Plan testing before execution
Define the ISO 10993 testing strategy, extraction approach and acceptance needs before laboratory work begins.
See how KARL STORZ worked with TÜV SÜD to plan and execute ISO 10993 testing, including chemical characterization and in-vitro cytotoxicity testing, to generate regulatory-grade evidence for submissions and lifecycle claims.
KARL STORZ: Planning and executing ISO 10993 testing with TÜV SÜD
KARL STORZ needed a testing programme that could demonstrate that reusable surgical instruments remain biologically safe over their intended lifetime, including extensive reprocessing cycles.
Together with TÜV SÜD, the company defined the ISO 10993 testing approach step by step, aligning extraction procedures, test parameters, laboratory capacity and project coordination to support reliable execution and keep timelines on track.
The test programme focused on chemical characterization of device extracts according to ISO 10993-18 and in-vitro cytotoxicity testing according to ISO 10993-5. For complex reusable devices, suitable extraction vessels, representative conditions and intensified test parameters were essential to produce meaningful, regulator-ready results.
What manufacturers can learn from their testing journey
Test under representative lifecycle conditions
Use extraction methods, chemical characterization and test parameters that reflect realistic worst-case use and repeated reprocessing scenarios.
Generate test data regulators can trust
Use independent, internationally recognized laboratory testing to support technical documentation, regulatory submissions, lifecycle claims and global acceptance.