Overview
ISO 19213:2017 - "Implants for surgery - Test methods of material for use as a cortical bone model" defines standardized static mechanical test methods for materials intended to act as cortical bone models. The standard helps characterize material properties so that bone models can be used reliably when evaluating devices and instruments for orthopaedic, plastic, neurosurgical, and oral/maxillofacial applications. Dynamic, viscoelastic, and poroelastic tests are explicitly out of scope.
Key Topics and Requirements
- Selection of test methods: Guidance on choosing appropriate fundamental and practical tests to represent cortical bone behavior for a given application.
- Fundamental mechanical tests: Includes compressive, tensile, shear, hardness, Charpy and Izod impact tests, and diametral tensile strength (DTS).
- Practical tests: Methods that replicate device interactions such as torque and axial pull-out (screw pull-out), ultrasonic cutting (oscillating scaler tips), and drilling performance on bone-model materials.
- Specimen and test setup: Requirements related to specimen shape/dimensions, anisotropic materials, conditioning/test atmosphere, preload, and calibration of testing machines (referencing ISO 7500-1).
- Data recording and reporting: Instructions for measurement, calculation of strength/strain parameters, statistical interpretation, and preparation of a final test report.
- Normative references: Incorporates established test methods from ISO and ASTM (for example ISO 527, ISO 604, ISO 179/180, ASTM D638/D695/D256) to ensure consistency and comparability.
Practical Applications and Who Uses This Standard
ISO 19213:2017 is intended for organizations and professionals involved in:
- Medical device manufacturers validating implants, fixation devices, and surgical instruments against realistic cortical bone behavior.
- Materials suppliers developing and certifying synthetic cortical bone blocks and composites.
- Independent test laboratories performing standardized mechanical tests for regulatory submissions or product development.
- Regulatory bodies and conformity assessors evaluating test data supporting device safety and performance claims.
- Academic and clinical researchers studying mechanical interactions between devices and cortical bone analogs.
- Surgical educators and simulation developers using validated bone models for training, pre-operative planning, and device demonstrations.
Benefits include more reproducible device testing (compared with animal bone), reduced sanitary/variance issues, and improved relevance of bench tests to clinical performance.
Related Standards
Key referenced standards used together with ISO 19213 include:
- ISO 527 (tensile properties), ISO 604 (compressive properties), ISO 179/180 (impact tests), ISO 2039-2 (hardness), ISO 7500-1 (machine calibration)
- ASTM standards such as ASTM D638, D695, D256 and ASTM F543 (bone screw testing)
Keywords: ISO 19213:2017, cortical bone model, mechanical test methods, implants for surgery, bone model testing, orthopaedic device testing.
Открыть превью (PDF)Implants for surgery — Test methods of material for use as a cortical bone model