Biocompatibility Studies

Microbial Identification Testing

Genotoxicity is a critical endpoint in biological evaluations, essential for safeguarding patient health and ensuring the safety of medical devices. At DIQC Lifesciences, we specialize in conducting rigorous genotoxicity tests to assess the potential of chemicals released from devices to cause gene mutations, chromosomal changes, or other DNA alterations that could lead to carcinogenic effects

Our approach includes:

• Comprehensive genotoxicity testing in compliance with ISO 10993-3 standards.
• Assessment of test results as part of a complete biocompatibility evaluation report, ensuring a holistic understanding of the device’s safety profile.
• Utilization of this data for inclusion in regulatory submissions to meet global compliance requirements.
• With extensive experience and adherence to the highest standards, DIQC Lifesciences provides precise and reliable genotoxicity testing to support your product’s success in the international market.

ISO 10993-18 Chemical Characterization Testing at DIQC Lifesciences

DIQC Lifesciences offers advanced chemical characterization testing to assess the safety and quality of medical devices. Adhering to ISO 10993-18 standards, we provide comprehensive testing to ensure reproducibility and consistent manufacturing.

Our capabilities include:

• Differential Scanning Calorimetry (DSC)
• Fourier Transform Infrared Spectroscopy (FTIR)
• Gas Chromatography-Mass Spectroscopy for Semi-Volatiles and Volatiles
• Inductively Coupled-Plasma Optical Emission Spectroscopy for Inorganics/Metals
• Liquid Chromatography-UV/VIS Spectroscopy for Non-Volatiles

These tests ensure device components meet regulatory requirements for safety and performance.

ISO 10993-4 Hemocompatibility Testing

Hemocompatibility testing is essential for ensuring the safety and compatibility of blood-contacting medical devices and biomaterials. At DIQC Lifesciences, we conduct thorough evaluations to assess the potential adverse effects of these devices on blood and its components, in strict compliance with ISO 10993-4 standards.

Our tests address critical reactions, including:

• Thrombosis: Blood clot formation
• Hemolysis: Destruction of red blood cells.
• Platelet Activation: Leading to potential clotting
• Leukocyte Activation: White blood cell immune responses
• Complement Activation: Triggering parts of the immune system

We also evaluate other blood-associated adverse events to ensure comprehensive safety and effectiveness. Our hemocompatibility testing services include:

• SC5b-9 Complement Activation Assay
• Thrombo-resistance Studies
• C3a Complement Activation Assay
• ASTM Hemolysis Testing
• CoASTM Partial Thromboplastin Time (PTT) Testing

By integrating advanced methodologies and expert analysis, DIQC Lifesciences provides reliable hemocompatibility assessments to meet the highest regulatory and clinical standards, ensuring patient safety in real-world applications.

ISO 10993-5 Cytotoxicity Testing

Cytotoxicity testing is a fundamental step in evaluating the biocompatibility of medical devices, biomaterials, and their extracts. These tests determine the potential for cell death (lysis), inhibition of cell growth, or other adverse effects on cellular structures caused by device materials. At DIQC Lifesciences, we conduct cytotoxicity evaluations in compliance with ISO 10993-5 standards, ensuring that your medical devices are safe and suitable for regulatory approval and human use.

Our cytotoxicity testing methodologies include:

• Direct Contact Method: Evaluates direct interaction between the device and cell cultures.
• Agar Diffusion Method: Assesses diffusion of leachable substances through agar to the cells.
• Agarose Overlay Method: Provides a sensitive analysis of cytotoxic effects.
• ISO and USP Elution Methods: Test extracts of materials for potential cytotoxic agents.
• MEM Elution Method: Measures cytotoxicity in extracts using minimal essential medium.
• Colony Assay – Japanese MHLW: Specialized method for cell colony evaluation.
• MTT Cytotoxicity Study: Quantifies cell viability using a colorimetric assay.

By leveraging these advanced techniques, DIQC Lifesciences provides a comprehensive evaluation of materials used in medical devices. This ensures adherence to global regulatory standards and supports the safe introduction of innovative medical technologies.

ISO 10993-6 Implant Testing

DIQC Lifesciences offers advanced histological testing and evaluation for implanted medical devices. We provide expert histopathology services, including tissue collection, processing, and analysis under the supervision of certified professionals.

Our offerings include

• Custom sample preparation
• Necropsy services
• Decalcified processing
• Photomicrograph documentation
• Efficient reporting

With state-of-the-art histology labs and a commitment to accuracy, we ensure comprehensive and timely evaluation of medical devices for regulatory compliance.

ISO 10993-10 Sensitization Testing

Sensitization testing is crucial for evaluating the biocompatibility of medical devices. It helps determine whether a device or its materials could cause allergic reactions after prolonged exposure. DIQC Lifesciences follows ISO 10993-10 guidelines to perform sensitization tests, offering methods such as Maximization Sensitization Studies, Closed Patch Sensitization Studies, and others. We ensure precise results through controlled studies to assess the potential for delayed, non-localized allergic reactions, based on the type of tissue contact.

ISO 10993-11 System Toxicity Testing at DIQC Lifesciences

Systemic toxicity testing is essential to assess the biological effects of medical devices on organs and tissues. DIQC Lifesciences performs systemic toxicity studies based on ISO 10993-11 guidelines, evaluating the potential adverse effects after exposure to devices or their biomaterials.

Our systemic toxicity testing services include:

• Subacute-Subchronic Systemic Toxicity Study Following Implant
• JP Systemic Toxicity Study
• Systemic Toxicity Study – Japanese MHLW
• ISO Acute Systemic Toxicity Study – Extract
• Systemic Toxicity Study – Solution
• USP Systemic Toxicity Study – Extract
• Chronic Systemic Toxicity Study in Subjects Following Implant
• Systemic Toxicity Study – Repeated Parenteral Subjection

ISO 10993-23 Irritation Testing at DIQC Lifesciences

Irritation testing is essential for evaluating the potential of medical devices, biomaterials, or their extracts to cause irritation to skin, eyes, or mucous membranes. DIQC Lifesciences conducts irritation studies following ISO 10993-23 standards to identify adverse reactions early, ensuring the safety and biocompatibility of medical devices before clinical use.

Our testing includes:

• Oral Mucosal Irritation Study – Surgical Method
• Intravitreal Injection Study
• USP Intracutaneous Study
• Intraocular Irritation Study
• ISO Ocular Irritation Study
• In Vitro Irritation Assay
• FHSA Skin Irritation Study

These tests help determine the irritation potential, ensuring devices meet safety standards for human use.