Many are Armoloy-coated. Although single-use devices will only be utilized once, doctors, dentists, and the patients who rely on them need the item’s performance to be maximized. For many types of medical instruments, that means applying a biocompatible chromium coating.
ISO 10993-11
ISO 10993-11
Systemic Toxicity Testing
ME-92® Coating Passes Systemic Toxicity Testing with Zero Adverse Effects
summary
What Is Systemic Toxicity?
Systemic toxicity refers to harmful effects a material or its leachables might cause throughout the body, rather than just at the site of contact. In medical device safety evaluations, systemic toxicity testing ensures that device materials won’t trigger internal organ damage, behavioral changes, or death after entering systemic circulation.
According to ISO 10993-11, systemic toxicity testing is essential for implantable, blood-contacting, or drug-delivering devices, where leachables may spread beyond the application site. Testing helps verify the material's safety profile and supports regulatory submissions.
What is a Systemic Toxicity Test?
A systemic toxicity test evaluates whether substances extracted from a medical device cause adverse effects when administered into an organism’s body. In this study, ME-92’s coating extract was evaluated using:
- Two extraction vehicles: 0.9% Sodium Chloride (saline) and Sesame Oil
- Two administration routes: Intravenous (IV) and Intraperitoneal (IP)
- Test species: Mice, in accordance with ISO 10993-11
Animals were monitored over 72 hours for:
- Clinical signs of systemic toxicity (e.g., prostration, convulsions)
- Mortality
- Weight loss (≥2g considered significant)
ME-92 Systemic Toxicity Study Summary
ME-92’s proprietary thin dense chrome coating, applied to 304 stainless steel (Lot #38408), was tested at NAMSA, a globally accredited lab.
- Number of animals tested: 20 mice (10 for each extract group)
- Mortality: 0%
- Clinical signs: None observed in any test or control group
- Weight changes: All animals maintained or gained weight within normal range
Each extract and dosage route met the requirements of ISO 10993-11 for acute systemic toxicity.
Why Toxicity Testing Matters
Systemic toxicity testing confirms that ME-92 coatings are safe for full-body exposure—a critical factor for medical devices used internally. These results strengthen ME-92’s profile as a biocompatible coating suitable for surgical implants, blood-contact devices, and tools requiring systemic safety assurance.
Other Biocompatibility Standards
Explore more compatibility standards we certify to.
Frequently Asked Questions
Yes, as long as the weld is machined and blended. This is a positive application to consider since a welded area is very susceptible to corrosion during autoclave.
Biocompatible coatings enhance the durability, safety, and performance of surgical instruments by preventing corrosion and wear while ensuring they remain safe for use in the body. To learn more about the key benefits and differences between coating types like BIO-TDC and ME-92, read our full blog here.
A disposable medical instrument must perform as well as a reusable device and even disposable instruments require autoclave prior to use. Disposable instruments experience galling and dulling of edges during their short usage, but still must perform to a high level. The ME-92® biocompatible coating reduces these undesirable occurrences.
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Systemic safety is non-negotiable. Trust ME-92 to deliver biocompatible coatings that meet ISO standards across every layer of patient protection.