Design for ISO testing compliance

Since our design is intended to come in contact with the human body (any kind of contact, brief or permanent, in any location of the human body,
we are to comply with ISO 10993-1 and any of the additional chapters of this standard that may apply to your specific device. 
The necessary biocompatibility tests are to be done. These include;

1. Risk Assessment to identify potential biocompatibility issues associated with the materials used in our device, assess the materials' chemical composition, and determine any potential dangers associated with prolonged skin contact.
2. Material Composition to ensure all materials are thoroughly characterized to determine their physical and chemical properties. This will help determine the material's nature and usage.
3. Cytotoxicity Testing (ISO 10993-5) to evaluate the biological response of cells to the materials used in our device. This involves direct contact with cultured cells to assess any harmful effects.
4. Sensitization Testing (ISO 10993-10) to determine if the materials can cause allergic reactions when in contact with skin. This can involve conducting a guinea pig test.
5. Irritation Testing (ISO 10993-10) to evaluate skin irritation potential using tests to assess the response of skin to the materials, typically through in vivo testing methods.
6. Extraction Studies (ISO 10993-12) to evaluate any leachable substances that may migrate from the device materials into the body.

Finally, all results are to be compiled to determine if the device meets the safety requirements outlined in ISO 10993-1. If the results show that the device materials are biocompatible, we can confidently assert compliance.