Biocompatibility Testing Matrix

Test for Consideration (Based on ISO 10993-1:2018 & FDA 2016 Guidance on ISO 10993-1)

- Body Contact
- Choose Body Contact
- Choose Surface Devices
- Choose Externally Communicating Devices
- Choose Implant Devices
- Choose Exposure Duration
- Regulatory Requirements
- Required
  - Physical and/or Chemical Information
  ISO Endpoits to be Evaluated
  - Cytotoxicity
  - Sensitization
  - Irritation
- Required
  - Physical and/or Chemical Information
  ISO Endpoits to be Evaluated
  - Cytotoxicity
  - Sensitization
  - Irritation
- Required
  - Physical and/or Chemical Information
  ISO Endpoits to be Evaluated
  - Cytotoxicity
  - Sensitization
  - Irritation
  - Acute Systemic Toxicity
  - Acute Systemic Toxicity
  - Implantation
  Additional Tests Considered Applicable by the FDA
  - Pyrogenicity
- Required
  - Physical and/or Chemical Information
  ISO Endpoits to be Evaluated
  - Cytotoxicity
  - Sensitization
  - Irritation
  - Acute Systemic Toxicity
  - Subacute Toxicity
  - Implantation
  - Subchronic Toxicity
  - Genotoxicity
  - Chronic Toxicity
  Additional Tests Considered Applicable by the FDA
  - Pyrogenicity
- Required
  - Physical and/or Chemical Information
  ISO Endpoits to be Evaluated
  - Cytotoxicity
  - Sensitization
  - Irritation
  - Acute Systemic Toxicity
  - Pyrogenicity
- Required
  - Physical and/or Chemical Information
  ISO Endpoits to be Evaluated
  - Cytotoxicity
  - Sensitization
  - Irritation
  - Acute Systemic Toxicity
  - Pyrogenicity
  - Subacute Toxicity
  - Implantation
  Additional Tests Considered Applicable by the FDA
  - Subchronic Toxicity
- Required
  - Physical and/or Chemical Information
  ISO Endpoits to be Evaluated
  - Cytotoxicity
  - Sensitization
  - Irritation
  - Acute Systemic Toxicity
  - Pyrogenicity
  - Subacute Toxicity
  - Subchronic Toxicity
  - Genotoxicity
  - Implantation
  - Chronic Toxicity
  - Carcinogenicity
- Required
  - Physical and/or Chemical Information
  ISO Endpoits to be Evaluated
  - Cytotoxicity
  - Sensitization
  - Irritation
  - Acute Systemic Toxicity
  - Pyrogenicity
  - Hemocompatibility
- Required
  - Physical and/or Chemical Information
  ISO Endpoits to be Evaluated
  - Cytotoxicity
  - Sensitization
  - Irritation
  - Acute Systemic Toxicity
  - Pyrogenicity
  - Subacute Toxicity
  - Hemocompatibility
  Additional Tests Considered Applicable by the FDA
  - Subchronic Toxicity
- Required
  - Physical and/or Chemical Information
  ISO Endpoits to be Evaluated
  - Cytotoxicity
  - Sensitization
  - Irritation
  - Acute Systemic Toxicity
  - Pyrogenicity
  - Subacute Toxicity
  - Subchronic Toxicity
  - Genotoxicity
  - Implantation
  - Hemocompatibility
  - Chronic Toxicity
  - Carcinogenicity
- Required
  - Physical and/or Chemical Information
  ISO Endpoits to be Evaluated
  - Cytotoxicity
  - Sensitization
  - Irritation
  - Acute Systemic Toxicity
  - Pyrogenicity
- Required
  - Physical and/or Chemical Information
  ISO Endpoits to be Evaluated
  - Cytotoxicity
  - Sensitization
  - Irritation
  - Acute Systemic Toxicity
  - Pyrogenicity
  - Subacute Toxicity
  - Genotoxicity
  - Implantation
  Additional Tests Considered Applicable by the FDA
  - Subchronic Toxicity
- Required
  - Physical and/or Chemical Information
  ISO Endpoits to be Evaluated
  - Cytotoxicity
  - Sensitization
  - Irritation
  - Acute Systemic Toxicity
  - Pyrogenicity
  - Subacute Toxicity
  - Subchronic Toxicity
  - Genotoxicity
  - Implantation
  - Chronic Toxicity
  - Carcinogenicity
- Required
  - Physical and/or Chemical Information
  ISO Endpoits to be Evaluated
  - Cytotoxicity
  - Sensitization
  - Irritation
  - Acute Systemic Toxicity
  - Pyrogenicity
  - Genotoxicity
  - Hemocompatibility
- Required
  - Physical and/or Chemical Information
  ISO Endpoits to be Evaluated
  - Cytotoxicity
  - Sensitization
  - Irritation
  - Acute Systemic Toxicity
  - Pyrogenicity
  - Subacute Toxicity
  - Genotoxicity
  - Implantation
  - Hemocompatibility
  Additional Tests Considered Applicable by the FDA
  - Subchronic Toxicity
- Required
  - Physical and/or Chemical Information
  ISO Endpoits to be Evaluated
  - Cytotoxicity
  - Sensitization
  - Irritation
  - Acute Systemic Toxicity
  - Pyrogenicity
  - Subacute Toxicity
  - Subchronic Toxicity
  - Genotoxicity
  - Implantation
  - Hemocompatibility
  - Chronic Toxicity
  - Carcinogenicity
- Required
  - Physical and/or Chemical Information
  ISO Endpoits to be Evaluated
  - Cytotoxicity
  - Sensitization
  - Irritation
  - Acute Systemic Toxicity
  - Pyrogenicity
- Required
  - Physical and/or Chemical Information
  ISO Endpoits to be Evaluated
  - Cytotoxicity
  - Sensitization
  - Irritation
  - Acute Systemic Toxicity
  - Pyrogenicity
  - Subacute Toxicity
  - Genotoxicity
  - Implantation
  Additional Tests Considered Applicable by the FDA
  - Subchronic Toxicity
- Required
  - Physical and/or Chemical Information
  ISO Endpoits to be Evaluated
  - Cytotoxicity
  - Sensitization
  - Irritation
  - Acute Systemic Toxicity
  - Pyrogenicity
  - Subacute Toxicity
  - Subchronic Toxicity
  - Genotoxicity
  - Implantation
  - Chronic Toxicity
  - Carcinogenicity
- Required
  - Physical and/or Chemical Information
  ISO Endpoits to be Evaluated
  - Cytotoxicity
  - Sensitization
  - Irritation
  - Acute Systemic Toxicity
  - Pyrogenicity
  - Genotoxicity
  - Implantation
  - Hemocompatibility
- Required
  - Physical and/or Chemical Information
  ISO Endpoits to be Evaluated
  - Cytotoxicity
  - Sensitization
  - Irritation
  - Acute Systemic Toxicity
  - Pyrogenicity
  - Subacute Toxicity
  - Genotoxicity
  - Implantation
  - Hemocompatibility
  Additional Tests Considered Applicable by the FDA
  - Subchronic Toxicity
- Required
  - Physical and/or Chemical Information
  ISO Endpoits to be Evaluated
  - Cytotoxicity
  - Sensitization
  - Irritation
  - Acute Systemic Toxicity
  - Pyrogenicity
  - Subacute Toxicity
  - Subchronic Toxicity
  - Genotoxicity
  - Implantation
  - Hemocompatibility
  - Chronic Toxicity
  - Carcinogenicity
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* The results of the above calculator are only recommendations. It is necessary to verify the results with company representatives

Biocompatibility Testing Matrix

Body Contact

Regulatory Requirements

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