BIOCOMPATIBILITY TESTING SERVICES

We specialise in biocompatibility testing and offer standard or customised biological evaluation assays, with expert in-house teams using the latest biocompatibility testing methods.


Virologica provides comprehensive biocompatibility testing services for medical devices and materials across the UK. Our accredited laboratory specialises in ISO 10993, OECD 439, and USP 87 testing protocols, ensuring regulatory compliance and product safety for pharmaceutical and medical device manufacturers.

Biocompatibility Testing Services Testing in UK - Virologica

We can offer a comprehensive range of biocompatibility testing services and laboratory solutions, including:

+ ISO 10993-5

BIOLOGICAL EVALUATION OF MEDICAL DEVICES - TESTS FOR IN VITRO CYTOTOXICITY

ISO 10993-5 provides the general requirements for evaluating the cytotoxic potential of a medical device through specialised laboratory testing. The in vitro tests described assess the cytotoxic potential of a device or material to inhibit cell growth or cause cell death and can be performed qualitatively and/or quantitatively in our accredited biocompatibility testing laboratory. There are three categories of test – extract test, direct contact test and indirect contact test. The appropriate test method is selected based on the nature of the sample, the potential site of use and the nature of use.

+ OECD 439

IN VITRO SKIN IRRITATION – RECONSTRUCTED HUMAN EPIDERMIS TEST METHOD

OECD 439 describes an in vitro procedure that may be used for the hazard group identification of irritant chemicals in accordance with the UN Globally Harmonized System of Classification and Labelling (GHS) in Category 2 using advanced laboratory techniques. Reconstructed human epidermis is exposed to the test substance, following exposure cell viability is measured quantitatively in our specialised biocompatibility testing facility. Irritant test substances are identified by their ability to decrease cell viability below defined threshold levels.

+ USP 87

BIOLOGICAL REACTIVITY TESTS – IN VITRO

USP 87 details test methods designed to determine the biological reactivity of mammalian cell cultures following contact with elastomeric plastics and other polymeric materials with direct or indirect patient contact or of specific extracts prepared from the materials under test in our professional laboratory environment. Three tests are described – agar diffusion test, direct contact test and elution test. The appropriate test method is selected based on the nature of the sample, the potential site of use and the nature of use. The biological reactivity is rated on a scale of 0 to 4 qualitatively through our comprehensive biocompatibility testing services.

What Is Biocompatibility Testing?

Biocompatibility testing is a critical process used to evaluate whether a material or medical device is safe for contact with the human body. It ensures that the device performs its intended medical function without causing harmful biological responses such as irritation, cytotoxicity, or sensitisation.

Our biocompatibility testing services focus on identifying any risks associated with the use of medical devices, implants, or healthcare materials. Testing is conducted according to internationally recognised standards, such as ISO 10993 testing, UK, OECD guidelines, and USP protocols. These standards help determine how a product will interact with biological systems under various conditions.

In addition to biocompatibility, we also offer biofilm efficacy testing for medical devices where bacterial resistance is a concern. Our accredited laboratory performs both biocompatibility testing and efficacy testing on biofilm to ensure comprehensive product evaluation.

Why Biocompatibility Testing Matters for Medical Devices

Biocompatibility testing is essential for protecting patient safety and meeting regulatory requirements. Without proper testing, medical devices may cause adverse biological effects such as inflammation, toxicity, or immune reactions, which could lead to regulatory rejection or product recalls.

Manufacturers seeking approval from regulatory bodies, including the UK MHRA, US FDA, or EU Notified Bodies, must complete robust biocompatibility testing in accordance with ISO 10993 and other relevant standards. Our biocompatibility testing services in the UK ensure compliance with these regulatory frameworks, helping you navigate complex submission processes.

Our laboratory not only provides biocompatibility testing but also specialises in biofilm testing labs services, allowing clients to assess both the safety and antimicrobial performance of their devices. Combining ISO 10993 testing UK with biofilm efficacy testing allows for a holistic approach to medical device evaluation, giving you a competitive edge in both safety and effectiveness.

Our Biocompatibility Testing Process

Virologica provides an efficient, compliant, and client-focused approach to biocompatibility testing services. Our process ensures that your medical device meets both regulatory requirements and the highest standards of patient safety:

  1. Initial Consultation & Risk Assessment
    We start by evaluating your product’s intended use, material composition, and exposure type. Our team then determines the necessary testing based on ISO 10993 testing UK standards and additional regulatory guidelines.

  2. Test Plan Development & Regulatory Strategy
    We create a tailored testing strategy that aligns with your product’s risk classification and clinical application. This may include cytotoxicity testing, skin irritation, sensitisation, and other evaluations.

  3. Laboratory Testing
    Our fully accredited laboratory conducts advanced biocompatibility testing using industry-standard methods, including ISO 10993-5 cytotoxicity, OECD 439 skin irritation testing, and USP 87 biological reactivity testing. For devices prone to microbial contamination, we also provide biofilm efficacy testing and efficacy testing on biofilm to measure antimicrobial properties.

  4. Data Interpretation & Reporting
    After testing, we analyse the results in detail and provide comprehensive reports that include expert commentary, risk assessments, and regulatory recommendations to support your device submissions.

  5. Post-Test Regulatory Support
    We offer ongoing support to assist with regulatory submissions, address additional testing needs, and provide guidance for complex cases.

With Virologica’s biocompatibility testing services, including biofilm testing labs and ISO 10993 testing UK, you gain access to expert analysis, rapid turnaround times, and full regulatory compliance support.

FAQ

  • Biocompatibility testing services evaluate if medical devices are safe and non-toxic for human use as per ISO 10993, OECD, and USP standards.

  • It ensures medical devices won’t cause harmful effects like irritation, cytotoxicity, or immune reactions, meeting strict regulatory standards.

  • Virologica offers ISO 10993-5 cytotoxicity, OECD 439 skin irritation, USP 87 reactivity, and customised testing per device needs.

  • Yes, Virologica specialises in ISO 10993 testing in the UK for full biological evaluation of medical devices and materials.

  • Testing time varies by product type, but Virologica ensures fast turnaround with expert analysis and regulatory support.