Non-Active Medical Device Testing
Non-active medical device testing evaluates the mechanical performance, fatigue life, and structural integrity of implants and devices that do not rely on a power source to perform their intended function. Additionally, this testing verifies orthopedic hip, knee, and trauma devices, spinal fixation and reconstruction implants, dental implant systems, and specialized device coatings. Furthermore, laboratories evaluate these products against the applicable ISO and ASTM standards that govern each device category.
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When to Use Non-Active Medical Device Testing
This testing provides an ideal solution when implantable or non-powered medical devices must demonstrate mechanical performance before clinical use. Additionally, manufacturers commonly request this testing for hip and knee prostheses, trauma fixation hardware, spinal rods, screws, cages, artificial discs, endosseous dental implant systems, and calcium phosphate, hydroxyapatite, or metallic implant coatings. Furthermore, manufacturers use this testing to support 510(k) and PMA submissions, satisfy CE marking requirements, validate design or material changes, and compare performance across product lines.
The Importance of Non-Active Medical Device Testing
Non-active implants must perform reliably inside the body for years, and often decades, without a power source to compensate for wear, fatigue, or loosening. Additionally, these devices experience repeated mechanical loading from walking, chewing, and spinal motion throughout their service life. If a device loosens, fractures, delaminates, or wears prematurely, it can compromise patient outcomes and lead to revision surgery. Therefore, comprehensive non-active medical device testing helps manufacturers identify these vulnerabilities before products reach the field.
- Verify mechanical performance and fatigue life across a wide range of non-active medical devices.
- Identify design weaknesses early in orthopedic, spinal, dental, and coated implant systems.
- Reduce the risk of field failures caused by cyclic loading, wear, and coating delamination in vivo.
- Generate objective, third-party data to support FDA and CE regulatory submissions.
- Partner with a single ISO/IEC 17025-accredited laboratory for testing to applicable ISO and ASTM standards.
Common Risks Reduced by Non-Active Medical Device Testing
- Fatigue fracture of stems, trays, plates, nails, rods, screws, or fixation hardware
- Loosening at modular junctions, screw-rod interfaces, and fixation surfaces
- Delamination or wear debris generation from coated or articulating surfaces
- Loss of disc height, torsional stability, or joint kinematics in spinal and dental systems
- Inconsistent performance across implant sizes, materials, and manufacturing lots
How Testing Results Support Design Decisions
Laboratory data helps engineering and quality teams compare device performance against applicable ISO and ASTM standards or internal design specifications. Additionally, testing identifies common failure modes, including fatigue fracture, interface loosening, coating delamination, and wear. As a result, manufacturers can apply insights from one device program to another. This broader evidence base helps engineers make targeted design improvements while avoiding unnecessary and costly redesigns.
Scope of Testing
The scope of non-active medical device testing spans orthopedic implant testing, spinal implant testing, dental implant testing, coating testing, and the fatigue and endurance testing that underlies nearly every device category. It extends beyond a simple pass or fail, evaluating static strength, fatigue life, wear resistance, corrosion behavior, and modular junction security across the full range of applicable standards. Manufacturers use this testing to validate new designs, compare configurations, and confirm readiness for regulatory submission.
Test Preparation and Sample Evaluation
Testing begins by documenting the device, confirming the configuration and materials represent intended clinical use, and selecting the applicable test standard, model, and fixture configuration based on device type, anatomical application, and the specific regulatory pathway being pursued.
Mechanical, Fatigue, and Environmental Testing
Non-active medical device testing applies static and cyclic loading, torque and torsion, disassembly force, and corrosion or fretting evaluation appropriate to the device family, ranging from ISO 7206 hip stem endurance testing and ASTM F1717 spinal construct testing to ISO 14801 dental implant fatigue testing and ASTM F1044-family coating adhesion testing, each configured to represent worst-case physiological conditions.
Documentation and Final Reporting
After testing, laboratory personnel inspect each specimen for evidence of fracture, deformation, wear, delamination, or loosening at critical interfaces. Reports document the test conditions, equipment used, load levels, cycle counts, failure modes, photographs, and final results, providing engineering data suitable for design improvement and regulatory documentation.
Overview of Non-Active Medical Device Testing Services
Applus+ Reliable Analysis’s non-active medical device testing program is organized around the device categories manufacturers most often need to validate together.
Orthopedic Implant Testing
Endurance, static load, and torque resistance testing of hip, knee, shoulder, and trauma devices in accordance with the ISO 7206 series and ASTM standards including F382, F384, F543, F564, F1264, and F1541.
Spinal Implant Testing
Static and fatigue testing of rods, screws, cages, and artificial discs in accordance with ASTM F1717, ISO 12189, ASTM F2077, ASTM F2346, and related spinal construct standards.
Dental Implant Testing
Dynamic fatigue and torsion testing of endosseous dental implant systems in accordance with ISO 14801 and ISO/TS 13498.
Coating Testing
Shear, tension, and fatigue testing of calcium phosphate, hydroxyapatite, and metallic implant coatings in accordance with ASTM F1044, F1147, and F1160.
Fatigue & Endurance Testing
Cross-category cyclic loading services that support every device family above, characterizing long-term durability under simulated physiological conditions.
Expert Non-Active Medical Device Testing Laboratory
Applus+ Reliable Analysis’s ISO/IEC 17025 accredited laboratory offers expert non-active medical device testing across orthopedic, spinal, dental, and coated implant categories. Applus+ Reliable Analysis has a full lab of test equipment which permits us to provide short lead times on scheduling. Explore the individual test method pages in this library for detailed procedures, or contact us to scope a complete non-active device testing program for your next regulatory submission. Request a quote today to get started!
