Services available for Biocompatibility
 
            
    
        Medical Device Biocompatibility Testing
We offer tests which evaluate cytotoxicity and biological risks within the chemical make-up of a medical device.
- 4-5 week typical lead time
- Biological Evaluation Plan & Report
- In Vitro & In Vivo methods
- Extractables & Leachables (E&L) Studies
- Also testing after cleaning, disinfection & sterilization
 
            
    
        Medical Device Biological Evaluation Plan
We complete Biological Safety Evaluation, following ISO 10993-1 standard to address possible biological hazards and risks associated with the clinical use of your medical device.
- 2 week typical lead time
- ISO 10993-1 – Biological evaluation of medical devices
- Meets the requirements of FDA / MDR
- Provides comprehensive ISO10993 testing plan
- Completed by in-house toxicologist (competent person)
 
            
    
        Medical Device Biological Evaluation Report
We produce a report which is a collective summary of all data used to assess the biocompatibility of your medical device.
- 2-3 week typical lead time
- ISO 10993-1 – Biological evaluation of medical devices
- Meets the requirements of FDA / MDR
- Provides comprehensive ISO10993 report
- Completed by in-house toxicologist (competent person)
 
            
    
        ISO 10993-5 Cytotoxicity Testing
We offer ISO 10993-5 cytotoxicity in vitro tests which evaluate biological risks within the chemical make-up of a medical device.
- 2-4 week typical lead time
- Good Laboratory Practice GLP study
- Biological Evaluation Plan
- Biological Evaluation Report
- ISO 10993-5 – cytotoxicity – in vitro methods
 
            
    
        ISO 10993-23 Test for Irritation
We offer ISO 10993-23 tests to determine irritation potential of their devices without the need for animal testing.
- 2-4 week typical lead time
- Good Laboratory Practice GLP study
- Biological Evaluation Plan
- Biological Evaluation Report
- ISO 10993-23 – test for irritation – in vitro methods
 
            
    
        Extractables & Leachables (E&L) Testing
We offer comprehensive Extractables & Leachables (E&L) testing to identify and quantify substances, supporting your product’s biocompatibility and regulatory compliance.
- 10-16 weeks typical lead time
- ISO 10993-18
- USP<1663>/<1664>, USP <665>/<1665>
- Aligned with MDR and FDA guidance
- Custom Extractables Study Design
 
            
    
        Residual Hydrogen Peroxide Determination
We assess hydrogen peroxide residues remaining on medical devices following H2O2 sterilisation processes to assess biocompatibility and patient safety.
- 2-3 week typical lead time
- BS EN ISO 22441:2022
- BS EN ISO 109931-1:2020
- BS EN ISO 10993-17:2023
- BS EN ISO 10993-18:2020+A1:2023