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 2025, EN ISO 10993-1 2020, FDA guidance September 2023 and ISO 18562-1
| Biological Effects | Requirement |
|---|
* Genotoxicity (Limited contact)
Only required for medical devices used in extracorporeal circuits or implantable medical devices.
† Local Effects After Tissue Contact
Only considered for medical devices having direct contact with other tissues in addition to circulating blood.
If tissue contact is indirect, this aspect is typically addressed within the haemocompatibility evaluation.
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 support you through the best path to regulatory compliance.
Biocompatibility Related Resources:
