Copper Sulfate Test
Detects free iron/defects on stainless instruments via copper deposition.
Overview
Confirm compatibility with the human body
Biocompatibility measures how safely a device or component co-exists with biological systems. The goal is to confirm suitability for human use and identify any potentially harmful physiological effects before clinical deployment.
ISO/IEC 17025:2017 accredited testing with decision-ready interpretation.
Why test
Safety, longevity, and functional reliability
Corrosion and biological interaction can undermine structural integrity and release harmful ions. Testing verifies resistance to degradation in physiological environments so electromedical devices, surgical instruments, and implants perform reliably without compromising patient health.
Scope
Tests we conduct
Cyclic Polarization
Evaluates implant susceptibility to localized corrosion under anodic/cathodic
Static Potential in SBF
Zero-current/rest potential in simulated body fluid to gauge corrosion tendency.
Boil Test
Rapid screening of surface integrity of surgical stainless instruments.
Outputs
Parameters evaluated
- Pitting resistance equivalent number (PREN).
- Corrosion potential Ecorr and rest potential (OCP).
- Corrosion current density Icorr and steady-state corrosion rate.
- Tafel slopes (βa, βc).
- Breakdown Eb, protection Ep, reverse Er, final Ef, and critical pitting potential Ecrit.
- Anodic & cathodic cycle behavior; passivation characteristics.
Methods
Guidelines & method families we apply
Stainless instruments
Procedures using boil and copper sulfate tests to reveal surface defects/impurities.
Small metallic implants
Cyclic polarization to assess susceptibility in stents, occluders, and similar devices.
Skeletal fixation devices
Requirements to verify security and effectiveness in orthopedic use.
Potentiodynamic polarization
Corrosion-potential assessment of metallic samples across biomedical environments.
Process
How we conduct the testing
Sample submission
Receive samples and device specs; define acceptance criteria.
Fixture design & development
Develop custom fixtures to replicate service conditions.
User-defined exposure
Select media (e.g., SBF) and cycles appropriate to device function.
Conduct tests
Execute corrosion/biocompatibility protocols under controlled conditions.
Experimental data
Capture potentials, currents, and morphology outcomes.
Surface characterization
Evaluate for defects, deposits, and passivation state.
Interpretation
Report, acceptance decision, and recommendations.
R&D
Initiatives & activities of our R&D team
- Assist in research & development initiatives.
- Deliver technical guidance to development and operations teams.
- Engage in the design & improvement of alloy materials for biomedical use.
Get in touch
Talk to an expert
Send device class, materials, and regulatory pathway. We’ll confirm the test matrix, reporting format, and lead indicators you need.