Corrosion testing services for medical devices

Corrosion testing for medical devices is a laboratory service used to evaluate the resistance of medical devices and materials to corrosion mechanisms that may occur during manufacturing, sterilization, storage, and clinical use. At Applus+ Laboratories, medical device corrosion testing services provide technical data related to material degradation, surface stability, and long‑term performance in aggressive environments. 

This testing is commonly applied to metallic implants, surgical instruments, and components exposed to physiological or chemical conditions. 

What is corrosion testing for medical devices? 

In medical device materials testing, corrosion testing is designed to assess how materials and assemblies react when exposed to environments that may promote electrochemical or chemical degradation. These environments may include physiological fluids, sterilization agents, cleaning solutions, or combined mechanical and chemical stresses. 

Medical device corrosion evaluation focuses on identifying susceptibility to localized or uniform corrosion phenomena that could affect device integrity or performance. 

Why corrosion testing for medical devices is important? 

Corrosion testing for medical devices is important because it: 

• Evaluates material behavior in simulated physiological environments 
• Identifies corrosion mechanisms that may affect long‑term performance 
• Addresses regulatory requirements related to material degradation products 
• Provides data to support material selection and surface treatment evaluation 
• Supports lifecycle performance assessments for metallic devices 

Benefits of corrosion testing for medical devices 

Medical device corrosion testing provides: 

• Objective data on corrosion resistance and susceptibility 
• Identification of localized and systemic corrosion mechanisms 
• Evaluation of surface treatments and coatings 
• Support for design verification and material comparisons 
• Technical input for risk and performance evaluations 

Our medical device corrosion testing capabilities 

Applus+ Laboratories performs medical device corrosion testing using electrochemical, immersion, and mechanical‑assisted methodologies aligned with international standards. 

Pitting and crevice corrosion testing 

Pitting and crevice corrosion testing is used to assess localized corrosion susceptibility under controlled electrochemical conditions. These tests are commonly applied to passive metallic materials and implantable components. 

Cyclic polarization testing 

Cyclic polarization testing evaluates breakdown potential, repassivation behavior, and corrosion resistance of metallic surfaces. This method is commonly used for implantable devices and metallic materials intended for long‑term implantation. 

Galvanic corrosion of dissimilar metals 

Galvanic corrosion testing evaluates corrosion interactions between dissimilar metals in electrical contact within an electrolyte. This testing is relevant for modular implants and assemblies combining different metallic materials. 

Long‑term immersion and fretting corrosion 

Long‑term immersion and fretting corrosion testing assesses material degradation under prolonged exposure to corrosive environments, with or without relative motion between contacting surfaces. These tests are commonly used for joint implants and modular connections. 

Additional corrosion testing capabilities 

Additional corrosion‑related testing capabilities include: 

• Corrosion testing of surgical instruments 
• Evaluation of surface treatments and coatings 
• Corrosion testing after sterilization cycles 
• Combined mechanical and corrosion fatigue evaluation for medical devices 

Common standards for medical device corrosion testing 

Medical device corrosion testing is aligned with internationally recognized standards that define test methods, environments, and evaluation criteria. 

ASTM F2129, ISO 10993‑15, and ISO 10271 

Examples of commonly applied standards include: 

• ASTM F2129 — Cyclic potentiodynamic polarization for corrosion susceptibility of implant materials 
• ISO 10993‑15 — Identification and quantification of degradation products from metals and alloys 
• ISO 10271 — Corrosion test methods for metallic dental materials 
• ASTM F1875 — Fretting corrosion testing of modular implant interfaces

Additional standards may be applied depending on device type, material composition, and intended use. 

Why choose Applus+ Laboratories for medical device corrosion testing services? 

Applus+ Laboratories provides corrosion testing for medical devices through a global network of accredited laboratories with expertise in biomaterials, electrochemistry, and surface science. 

• Technical expertise in electrochemical and material‑based corrosion evaluation 
• Experience across implantable devices, instruments, and metallic components 
• Testing aligned with applicable international standards 
• Lifecycle support from development through post‑market evaluation 
• Global laboratory presence enabling consistent methodologies and reporting 

These capabilities position Applus+ Laboratories as a qualified partner for medical device corrosion evaluation and medical device corrosion testing programs.