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Medical Device Biocompatibility Testing and ISO 10993 Compliance

#1 in Biocompatibility Testing Worldwide Since 1967

The biocompatibility of medical devices, directed by ISO 10993-1 and the USFDA Guidance, is a critical part of the medical device risk management process. Often referred to as biological safety, this evaluation of risk consists of multiple mechanisms that work together to accurately predict medical device biocompatibility based on individual materials and type and duration of patient contact. The use of biological evaluation plans, chemical characterization testing, biocompatibility testing, and toxicological risk assessment are all necessary components of the successful mitigation of biological risks.

200+ Tests for a Wide Range of Biomaterials

NAMSA’s tests for biocompatibility are conducted on a wide range of biomaterials, medical devices and other products to ensure safety from toxins or other harmful effects. Tests include initial screenings to product release testing, along with non-clinical safety evaluations that are compliant with current global standards.  Biological tests we can perform include:

  • Acute Systemic Toxicity Testing
  • Biodegradation Testing
  • Carcinogenicity Testing
  • Sub Chronic/Chronic Toxicity Testing
  • Cytotoxicity Testing
  • Genotoxicity Testing
  • Hemocompatibility Testing
  • Implantation Testing
  • Intracutaneous/skin Irritation Testing
  • In Vitro Irritation Testing
  • Sensitization Testing
  • Subchronic Toxicity Testing

ISO 10993-3 Genotoxicity Testing

Genotoxicity is a crucial biological evaluation endpoint that is crucial for protecting patient health.

Ô°ÇøÒùÂÒconducts thousands of genotoxicity tests each year to determine if chemicals released from a device might cause gene mutations, changes in chromosome structure, or other DNA or gene changes which may lead to a carcinogenic effect.

Once genotoxicity testing is performed, we assess it as part of the biocompatibility valuation report which evaluates the overall biocompatibility of the device.  These data are then used in various types of regulatory submissions to countries/regions around the globe.

ISO 10993-4 Hemocompatibility Testing

Hemocompatibility tests are conducted to evaluate the adverse effects of blood-contacting medical devices or biomaterials on blood or blood components. These tests assess various adverse reactions, including thrombosis (blood clot formation), hemolysis (destruction of red blood cells), platelet activation (which can lead to clotting), leukocyte activation (white blood cell response), and complement activation (part of the immune response). Additionally, other blood-associated adverse events are evaluated to ensure the safety and compatibility of the devices. Following the guidelines outlined in ISO 10993-4, these tests help ensure that medical devices are safe for use in clinical settings and do not cause harmful reactions in patients.

  • SC5b-9 Complement Activation Assay
  • Thrombo-resistance Study
  • C3a Complement Activation Assay
  • ASTM Hemolysis
  • ASTM Partial Thromboplastin Time

ISO 10993-5 Cytotoxicity Testing

Cytotoxicity tests are used to determine the lysis (death) of cells, colony formation, inhibition of cell growth, and other effects on cells caused by medical devices, bio-materials, or their extracts utilizing cell culture techniques. Adhering to ISO 10993-5 is essential for regulatory approval of medical devices. It ensures that the devices are biocompatible and safe for use in or on the human body. We can conduct cytotoxicity studies following various standards and methods, including direct contact, agar diffusion, and elution methods, to ensure comprehensive evaluation of the materials used in medical devices.

  • Colony Assay – Japanese MHLW
  • MEM Elution Method
  • Agarose Overlay Method
  • Agar Diffusion Method
  • USP Elution Method
  • ISO Elution Method
  • ISO Direct Contact Method
  • MTT Cytotoxcity Study

ISO 10993-6 Implant Testing

Ô°ÇøÒùÂÒprovides best-in-class histological technology for the testing and evaluation of implanted medical devices. Valuable tissues are collected and processed on-site and under the supervision of a Board Certified Pathologist. Histopathology laboratory services are also provided.

  • Consultation
  • Custom Sample Preparation and Sectioning
  • Histochemistry Capabilities
  • Necropsy Ô°ÇøÒùÂÒ
  • Non-Decalcified and Decalcified Processing and
  • Sectioning
  • Photomicrograph Documentation
  • Routine Paraffin Processing and Sectioning
  • Soft and Hard Resin (Plastic) Processing and Sectioning
  • State-of-the-Art Histology Laboratory
  • Timely and Efficient Reporting

ISO 10993-10 Sensitization Testing

Sensitization testing is a vital component of the biocompatibility assessment for medical devices. This testing determines whether a medical device, its biomaterials or their extracts, can cause an allergic reaction, known as sensitization, after repeated or prolonged exposure to the body. The process typically adheres to the guidelines set by ISO 10993-10, which is part of a series of standards for the biological evaluation of medical devices.

Sensitization is marked by delayed, non-localized reactions that occur regardless of the dose. The method chosen depends on the type of tissue contact.

  • Maximization Sensitization Study – Japanese MHLW (Ministry of Health, Labour and Welfare)
  • ISO Closed Patch Sensitization Study
  • ISO Maximization Sensitization Study

ISO 10993-11 System Toxicity Testing

ISO 10993-11 is a standard that outlines the procedures for evaluating the potential systemic toxicity of medical devices. Systemic Toxicity tests evaluate the generalized biological effects to organs and tissues following exposure to a medical device, bio-material, or their extracts.  The term systemic implies that the exposure occurs by one route and the toxic substance is carried to distant locations causing an adverse effect.  Systemic toxicity is typically evaluated in studies of acute, sub-acute, sub-chronic, and chronic duration based on the device’s intended exposure. Studies include:

  • Subacute- Subchronic Systemic Toxicity Study Following Implant
  • JP Systemic Toxicity Study
  • Systemic Toxicity Study- Japanese MHLW (Ministry of Health, Labour and Welfare)
  • ISO Acute Systemic Toxicity Study – Extract
  • Systemic Toxicity Study- Solution
  • USP Systemic Toxicity Study – Extract
  • Chronic Systemic Toxicity Study In Subjects Following Implant – (Chronic describes the longer duration of the study)
    Systemic Toxicity Study – Repeated Parenteral Subjection

ISO 10993-18 Chemical Characterization Testing

Ô°ÇøÒùÂÒprovides an extensive range of testing services to help secure product safety, quality, and consistency during all stages of development. Our processes are the most trusted in industry and help to efficiently define device components and enable assessment of reproducibility in manufacturing and processing. The successful implementation of this standard, ISO 10993-18, and evaluation outlined in supporting documents, is critical for medical device manufacturers if they wish to stay on track with market clearance plans. Some of our capabilities include, but are not limited to:

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

ISO 10993-23 Irritation Testing

Irritation tests are utilized to assess the irritation potential of medical devices, biomaterials, or their extracts when exposed to the eye, skin, or mucous membranes. This testing evaluates the potential of a device to cause irritation, such as redness, swelling, or pain, upon exposure. The tests are performed using models appropriate for the specific route (skin, eye, mucosa) and duration of exposure or contact, following the guidelines outlined in ISO 10993-23.  The goal is to identify any adverse reactions early, ensuring the safety and biocompatibility of the medical devices before they are approved for clinical use. Some common irritation studies include:

  • 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 (Federal Hazardous Substances Act)

Why Companies Choose NAMSA

118K +

Medical Device Tests Conducted Last Year

13

Board-Certified DABT Toxicologists on Staff

3

Major US and EU Labs Performing ISO 10993 Testing

800+

Biological Safety Plans and Reports Prepared Last Year

The Most Experienced Team of Biocompatibility Scientists and Toxicologists

NAMSA’s medical device biocompatibility testing team is composed of chemists, material specialists, toxicologists and other testing experts who work together to ensure your safety plan minimizes unnecessary testing, maintains compliance and provides evidence of device safety.

Our biocompatibility team does all testing in-house and evaluates your device’s component materials and regulatory pathways to help you minimize cost and time while developing your product.

Companies Trust Ô°ÇøÒùÂÒto Get It Right the First Time

At NAMSA, we understand the confidence you require in your biocompatibility testing partner to deliver high-quality, accurate results on your way to commercialization. We have been conducting biocompatibility testing since 1967. Our highly trained experts perform all tests in house to evaluate your device’s component material / finished product use and regulatory pathway — minimizing cost and development time.

  • ASCA accreditation means FDA and other regulators trust our results
  • 7 testing labs in the US and Europe
    • 95% on-time turnaround

It’s our commitment to move the testing process along with great care while respecting your timelines.

Medical Device Biological Safety

Ô°ÇøÒùÂÒdoes far more than testing! Ensuring biological safety is an extremely rigorous process, and our team works to achieve compliance through several steps that are encompassed our biological safety consulting services. Our process includes everything from creating a biological evaluation plan to gap analyses and adverse test result memos when needed.

Meet Our Team of Biocompatibility Experts

Explore the depth of our team’s expertise in medical device biocompatibility and ISO 10993 compliance.

Meet Our Full Team
  • Don Pohl, BS

    Principal Strategy Consultant, Biocompatibility
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  • Catherine Tremolieres, DVM

    Manager, Biological Safety & Validation Consulting Ô°ÇøÒùÂÒ, Europe
    View Bio
  • Sylvie Framery, PhD

    Senior Principal Biological Safety Scientist
    View Bio
  • Michelle Kelly, BSc, MSc, ERT

    Toxicologist
    View Bio
  • Alfred Dibao-Dina, PhD

    Biological Safety Scientist
    View Bio
  • Crystal Jurkiewicz, BS, MS, DABT

    Toxicologist
    View Bio

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