Biocompatibility Testing
Ensuring the safety of medical devices is a critical step in the regulatory pathway, and biocompatibility testing plays a vital role in this process. Cormica provides comprehensive ISO 10993 testing services, offering expert guidance to help you navigate the complex requirements of medical device testing. Supported by our world wide facilities with decades of scientific expertise, allow you to meet regulatory standards confidently and efficiently.
What is ISO 10993 Testing?
ISO 10993 is the internationally recognised standard for evaluating the biocompatibility of medical devices or combination devices. This series of tests assesses how your medical device interacts with biological systems, ensuring it is safe for human use. Depending on your product’s intended use and contact duration with the body, the appropriate tests are determined from the ISO 10993 matrix.
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ISO 10993 Test Finder
Supporting you with ISO 10993-1 2018, EN ISO 10993-1 2020, FDA guidance September 2023 and ISO 18562-1
E - Endpoints to be evaluated. X - prerequisite information needed for risk assessment. O - Additional FDA recommended endpoints for consideration
| Biological Endpoints | Requirement |
|---|
- Additional EU MDR requirement: Substances classified as Carcinogenic, Mutagenic, or toxic to Reproduction (CMR) of category 1A or 1B, or substances with Endocrine-Disrupting (ED) properties shall only be present in a devices or parts above 0.1% weight by weight.
NOTE:
- Transitory contact (subject to removal in current developing version of ISO 10993-1!) (< 1 minute) are not required for biocompatibility testing.
- Materials / medical devices containing or releasing nanoparticles should be considered as described in ISO 10993-22.
- Please discuss with your regulatory body or Cormica Group expert team the required endpoints that need to be addressed for you regulatory compliance.
Ensuring Patent Safety with Rigorous testing
How We Can Support You
The path to regulatory approval can be complex, long winded and extremely stressful. Our team of seasoned experts are here to assist you at every stage of launching and releasing your medical devices, from selecting the appropriate tests for your device to ensuring compliance with international regulations (EU MDR, EU IVDR, FDA, SOR/98-282, IMDRF, PMDA +)
Our Biocompatibility Testing Suite
- Chemical Characterization
- Cytotoxicity
- Irritation
- Sensitization
- Material Mediated Pyrogenicity
- Acute Systemic Toxicity
- Subacute Toxicity
- Subchronic Toxicity
- Chronic Toxicity
- Genotoxicity
- Carcinogenicity
- Hemocompatibility
- Implantation
- Reproductive / Developmental Toxicity
- Degradation
Cormica Consultancy
We also work closely with you to develop Biological Evaluation Plans (BEPs), Biological Evaluation Reports (BERs), Clinical Evaluation Plans (CEPs), and Clinical Evaluation Reports (CERs) that are critical for a thorough biocompatibility evaluation, meeting global regulatory expectations.
Contact our dedicated sales team to discuss your biocompatibility testing needs. We’ll help you navigate the complexities of ISO 10993 testing and guide you through the best path to regulatory compliance.
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