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For medical devices that come into direct or indirect contact with patients, biocompatibility tests are required to obtain regulatory approval before being placed on the market. Biocompatibility tests help determine whether a device performs as intended without causing any adverse or harmful effects to patients or users, and identify any biological risks posed by the device.
ISO 10993 is the primary standard used for medical device biocompatibility testing. The standard consists of 22 sections.
Determining the appropriate biocompatibility test according to ISO 10993-1
Determining and performing appropriate biocompatibility tests according to ISO 10993-1 helps avoid delays in regulatory approvals. Our team helps determine applicable biocompatibility tests depending on the type of device, intended use, nature and duration of contact with patients.
We can help you meet ISO 10993 biocompatibility testing requirements
Our comprehensive biocompatibility testing portfolio includes:
CYTOTOXICITY TESTING
INTRACUTANEOUS REACTIVITY TESTING
DERMAL IRRITATION TESTING
ACUTE SYSTEMIC TOXICITY TESTING
SUBCHRONE SYSTEMIC TOXICITY TESTING
SUBCHRONE/CHRONIC SYSTEMIC TOXICITY TESTING
IMPLANTATION TESTING
SENSITIZATION TESTING
BLOOD INTERACTION (HEMOLYSIS) TESTING
INVIVO PYROGENICITY TESTING EU PHARMACOPEA 9.0 2.6.8
INVIVO ABNORMAL TOXICITY TESTING EU PHARMACOPEA 9.0 2.6.9
GENOTOXICITY TEST - MUTATION TEST
AMES TEST
GENOTOXICITY TEST IN VITRO MICRONUCLEUS TEST
OECD 404 ACUTE DERMAL IRRITATION TEST FOR BIOCIDAL PRODUCTS
ISO 7405 - 6.2 CYTOTOXICITY TEST
ISO 7405 - 6.3 CYTOTOXICITY TEST
ISO 7405 - 6.4 PULP INSPECTION TEST
ISO 7405 - 6.5 PULP CAUFAFAGE TEST
ISO 7405 EKB CYTOTOXICITY TEST
ISO 7405 ANNEX B TEST
ISO 7405 ANNEX C TEST
ISO 7405 6.6 ENDODONTIC TESTING
BIOMATICITY LD 50 DOSE DETERMINATION TEST
Contact us for more information about ISO 10993 and our support with biocompatibility testing
- Creation and writing of the biosafety assessment strategy
- Decision whether parts of the biosafety assessment will undergo a scientific literature review
- Scientific writing of the literature study
- Selection of a testing laboratory
- Communication with this laboratory to identify the appropriate testing program, combination of tests, technical content of the test, organization of functionality studies, monitoring of testing timelines
- Interpretation of test results; resolution of these deviations, especially when the results are not very clear
- Writing of a general biosafety test report
- Interpretation if a design or process change affects the biological safety of a medical device
