background bubble helix decoration
systemic toxicity seen in cells

ISO 10993-11

Systemic Toxicity Testing

ME-92® Coating Passes Systemic Toxicity Testing with Zero Adverse Effects

Request Systemic Toxicity Results

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.
systemic toxicity specimen in beaker test

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)
systemic toxicity in cells of a pink color

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.

surgery operation

Why Toxicity Testing Matters

metal mesh stent plated with ME-92 coating by Armoloy

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.

intracutaneous needle
Intracutaneous Testing
blood test tube testing for hemolysis
Hemolysis Testing
cytotoxicity testing sample tray
Cytotoxicity Testing
pyrogen at enhanced magnification
Pyrogens
Dark blue cosmic visual

Partner With Us

Systemic safety is non-negotiable. Trust ME-92 to deliver biocompatible coatings that meet ISO standards across every layer of patient protection.

Let’s ChatRequest a Sample