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Medical Devices in TheraIndx Lifesciences!

Biocompatibility testing is a crucial aspect of ensuring the safety and effectiveness of medical devices, which is critical part of the regulatory approval and monitoring process. TheraIndx Lifesciences an ISO/IEC 17025:2017 certified with State-of-the-art testing facility is your preferred partner for medical devices testing. We have a team of subject matter experts in medical devices testing to design of studies as per regulatory guidelines for multicomponent and dynamic extraction processes as per International guidelines.

We provide biocompatibility testing for medical devices ISO 10993 to ensure compliance with industry-leading criteria. Additionally, we also adhere to the Biocompatibility testing ISO/IEC:17025:2017 to emphasize precision and quality in our testing procedures. As one of the leading biocompatibility testing laboratories, we prioritize the safety and effectiveness of medical devices and offer thorough assessments in line with global standards.

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Biocompatibility tests conducted in TheraIndx Lifesciences

IN VITRO Cytotoxicity testing

Test for in vitro Cytotoxicity

(ISO 10993-5)
  • Test on Extracts: MEM Elution
  • Direct Contact
  • Indirect contact: Agar diffusion
  • Quantitative Test by MTT

Test for Systemic Toxicity

(ISO 10993-11)

Acute systemic toxicity

genotoxicity testing

Tests for Genotoxicity

(ISO 10993-3)

Bacterial Reverse Mutation Test (Ames test)

Test for Irritation

(ISO-10993-23)

Intracutaneous Reactivity Test

Skin Sensitization Testing

Test for Skin Sensitization

(ISO-10993-10)

Guinea Pig Maximization Test (Magnusson-Kligman)

Test for Pyrogenicity

(ISO-10993-11)

Material Mediated Rabbit Pyrogenicity Test

Importance of Biocompatibility Testing

Patient
Safety

Biocompatibility testing is conducted to ensure the safety of patients who will be exposed to medical devices or implants.

It helps prevent adverse reactions such as allergies, inflammation, and other harmful responses.

Regulatory
Compliance

Regulatory bodies, such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), require biocompatibility testing as part of the approval process for medical devices.

Material
Evaluation

Assessing the biological response to materials helps in selecting or designing materials that are more compatible with the human body.

Types of Biocompatibility Tests

  • Cytotoxicity Testing

    Evaluates the toxic effects of materials on living cells, typically using cell cultures.

  • Sensitization Testing

    Determines whether the material induces an allergic response in the body

  • Hemocompatibility Testing

    Assesses the compatibility of materials with blood, ensuring that devices do not cause adverse effects on blood components.

  • Genotoxicity Testing

    Examines whether the material has the potential to damage genetic material.

  • Systemic Toxicity Testing

    Assesses the overall toxic effects of the material when introduced into the circulatory system.

  • Implantation Testing

    Involves placing the material or device directly into living tissues to observe the long-term effects, such as inflammation or tissue response.