Salt Spray Testing
Salt spray testing (also known as salt fog testing) is an accelerated corrosion test that evaluates the resistance of medical device materials, components and protective coatings to corrosive environments. This highly controlled test simulates extreme atmospheric conditions by continuously exposing devices to a controlled saline mist, helping manufacturers assess long-term durability and performance. By accelerating the effects of months or years of environmental exposure into a matter of days or weeks, salt spray testing provides manufacturers with reliable data to make informed decisions about material selection, design improvements and manufacturing processes - ultimately ensuring device safety and longevity in real-world clinical applications.
The test serves as a critical quality control measure that helps medical device manufacturers ensure :
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Patient Safety – Corrosion can lead to metal ion leaching, material degradation, or device failure, posing risks such as:
- Tissue irritation or toxicity (e.g., nickel or chromium release from stainless steel implants).
- Structural weakening (e.g., corroded surgical instruments or implants).
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Regulatory Compliance – Agencies like the FDA, EU MDR, and ISO require corrosion resistance validation for:
- Implantable devices (ISO 10993-15 for degradation testing).
- Surgical instruments (ASTM F1089 for stainless steel corrosion resistance).
- Product Reliability – Ensures devices maintain functionality in humid, saline, or bodily fluid environments.
Our Service
Meditronics (a brand of STEMart) conducts salt spray testing following ASTM B117 and ISO 9227. General testing process includes the follow steps:
1. Sample Preparation - Devices or material samples are cleaned to remove contaminants.
2. Test Chamber Setup – Samples are placed in a controlled salt spray chamber.
3. Exposure Duration – Typically ranges from 24 to 1,000+ hours, depending on material and regulatory requirements.
4. Post-Test Evaluation – Assessed for corrosion formation (e.g. rust, pitting, or discoloration); coating adhesion loss (e.g. peeling, blistering).
Why Choose Meditronics?
Meditronics stands out as a trusted partner for medical device manufacturers due to our:
✔ Regulatory Expertise
Our team ensures testing aligns with FDA, ISO, ASTM, and EU MDR requirements, providing detailed reports for regulatory submissions.
✔ Advanced Testing Equipment
We utilize state-of-the-art salt spray chambers with precise temperature, humidity, and spray controls for reproducible, accurate results.
✔ Accurate & Reliable Results
We deliver fast, reliable, and ISO 17025-accredited testing with rapid turnaround times, uncompromised data integrity, and comprehensive reports including pass/fail criteria and failure analysis.
✔ End-to-End Support
From material selection to final product validation, we help manufacturers identify corrosion risks early, optimize coatings and materials and ensure long-term device reliability.
Salt spray testing is a critical step in ensuring medical devices remain safe, durable, and compliant in corrosive environments. Meditronics's expertise, advanced testing capabilities, and regulatory knowledge provide manufacturers with the confidence to deliver high-quality, corrosion-resistant medical devices.
Contact Meditronics today to discuss your Salt Spray Testing needs.
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