Cytotoxicity Testing

Cytotoxicity testing is a critical component of biocompatibility evaluation for medical devices, assessing whether a device or its extracts cause harmful effects on living cells. As a fundamental requirement under ISO 10993-5, USP <87>, and other regulatory frameworks, cytotoxicity testing helps determine if a material releases toxic substances that could compromise patient safety. Given the increasing regulatory scrutiny on medical devices, manufacturers must ensure their products meet stringent biocompatibility standards before entering clinical trials or obtaining market approval. Meditronics's cytotoxicity testing services provide reliable, compliant, and efficient evaluations to support your product development and regulatory submissions.

2-1-cytotoxicity-testing (Generated by AI)

Our Service

Meditronics (a brand of STEMart) conducts cytotoxicity testing in full compliance with ISO 10993-5, USP <87>, and USP <1036>, employing multiple validated methodologies to assess cellular responses to medical device materials. Our testing approaches include:

Direct Contact Test

Evaluates the impact of solid materials placed directly on cell monolayers (e.g., L929 fibroblasts), observing morphological changes, cell lysis, and growth inhibition.

Elution (Extract) Test

Uses saline or cell culture media to extract leachable substances from materials, followed by exposure to cells and viability assessment via MTT, CCK-8, or Neutral Red Uptake assays.

Agar Diffusion Test

Assesses diffusible toxins by overlaying cells with agar and measuring cytotoxicity zones around test samples.

Filter Diffusion Test

Evaluates liquid or soluble extracts by diffusion through a membrane onto cultured cells.

Each method is selected based on the device's material composition, intended use, and regulatory requirements, ensuring scientifically robust and reproducible results.

Why Choose Meditronics?

Meditronics's cytotoxicity testing services are designed to meet FDA (21 CFR Part 820), EU MDR, and ISO 10993 compliance requirements. Our team of experienced toxicologists and regulatory specialists stays updated with evolving standards, ensuring your device meets global market expectations. We go beyond standardized testing by offering:

✔ ISO 10993-5, USP <87>, and FDA/EU MDR compliance

✔ Customized protocols for unique materials and applications

✔ Expert regulatory guidance and comprehensive reporting

✔ Fast turnaround times without compromising data integrity

With state-of-the-art laboratories, GLP-compliant procedures, and a commitment to fast turnaround times, Meditronics delivers high-quality cytotoxicity testing to accelerate your medical device's path to market.

By choosing Meditronics, you gain a trusted partner dedicated to ensuring your medical devices meet the highest safety and performance standards. Let us support your biocompatibility testing needs—reach out for a consultation or quotation today.

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