Medical device durability testing services

Medical device durability testing is a laboratory service used to evaluate how medical devices perform when subjected to repeated mechanical, environmental, and time‑based stresses. Medical device endurance testing provides data on wear, fatigue, material stability, and structural integrity over a device’s expected service life. 

This type of testing is commonly used to assess the long‑term performance of implantable and non‑implantable medical devices under simulated use conditions. 

What is durability testing for medical devices? 

Durability testing for medical devices is designed to assess how a device withstands mechanical loads, cyclic stresses, environmental exposure, and aging effects without unacceptable performance degradation. 

Durability testing services of medical devices is used to evaluate resistance to fatigue, wear, corrosion, and material failure when devices are exposed to conditions representative of clinical use, handling, storage, and transportation.

Benefits of durability testing for medical devices 

Medical device durability testing is commonly used to: 

• Evaluate long‑term performance under repeated or sustained loading 
• Assess material and structural resistance to fatigue and wear 
• Address regulatory requirements related to device lifetime and performance 
• Provide data to enable design verification and risk evaluations 
• Compare device performance before and after environmental or aging exposure 

What durability testing methods for medical devices do we perform? 

A range of durability testing methods is applied depending on the device type, intended use, and applicable standards.

Cyclic load and endurance testing 

Cyclic and endurance testing evaluates device behavior under repeated mechanical loading. This approach is commonly used for orthopedic implants, spinal systems, and surgical instruments exposed to repetitive forces during use. 

Our medical device durability testing capabilities 

Applus+ Laboratories performs medical device durability testing using controlled laboratory environments and standardized test configurations aligned with international guidelines. 

Mechanical testing 

Mechanical testing assesses strength and deformation properties under static and dynamic loads, including tension, compression, bending, and torsion. These tests are used to evaluate structural integrity and load‑bearing capacity. 

Fatigue testing and failure analysis 

Medical device endurance testing involves fatigue testing to determine device performance over millions of load cycles. When failures occur, failure analysis is conducted to evaluate fracture modes, damage mechanisms, and contributing factors.

Wear and corrosion test 

Wear and corrosion testing evaluates material degradation caused by friction, articulation, or exposure to physiological or aggressive environments. These tests are commonly used for joint implants, moving components, and metallic materials.

Accelerated aging and shelf‑life testing 

Accelerated aging and shelf‑life testing are used to evaluate material and functional stability over time. These tests provide data on performance after simulated long‑term storage and environmental exposure.

Environmental durability 

Environmental durability testing evaluates device performance under controlled environmental conditions that may affect materials or functionality.

Temperature 

Temperature‑based testing assesses device behavior when exposed to elevated or reduced temperatures, including thermal cycling where applicable. 

Humidity 

Humidity testing evaluates the effects of moisture exposure on materials, coatings, and assemblies, particularly for polymeric or electronic components.

Common standards for medical device durability testing 

Medical device durability testing is aligned with internationally recognized standards that define test conditions, load profiles, and acceptance criteria. 

ISO 14879‑1 and ASTM F1717 

Examples of commonly applied standards include: 

• ISO 14879‑1 – Fatigue testing of knee joint tibial components 
• ASTM F1717 – Spinal implant constructs fatigue and static testing 

Additional standards may be applied depending on device category, material type, and intended function. 

Why choose Applus+ Laboratories for ,edical device durability testing? 

Applus+ Laboratories provides medical device durability testing through a global network of accredited testing laboratories with experience across a wide range of medical technologies. 

• Technical expertise in mechanical, fatigue, wear, and environmental testing 
• Experience with implantable and non‑implantable medical devices 
• Testing aligned with applicable international standards 
• Lifecycle assessment from early development to post‑market activities 
• Global laboratory presence enabling consistent testing approaches 

These capabilities position Applus+ Laboratories as a qualified testing partner for durability testing of medical devices across development, verification, and long‑term performance evaluation stages.