Develop biocompatibility testing strategy ensuring patient-contact materials meet safety standards.
Component | Material | Supplier | Grade | Contact Assessment |
---|---|---|---|---|
Base Layer | Silicone elastomer | MedSil Corp | USP Class VI | Direct contact with wound bed |
Antimicrobial Coating | Silver nanoparticles | NanoSilver Inc | Medical grade | Direct contact with wound and surrounding tissue |
Adhesive Border | Acrylic adhesive | AdhesiveMed | Skin-contact approved | Direct contact with intact skin |
Backing Film | Polyurethane | FlexFilm Ltd | Medical grade | No patient contact |
Test Category | Required | Test Method | Rationale |
---|---|---|---|
Cytotoxicity | Yes | ISO 10993-5 | Screening test for all devices |
Sensitization | Yes | ISO 10993-10 | Extended skin contact requires sensitization assessment |
Irritation | Yes | ISO 10993-10 | Direct contact with compromised tissue |
Systemic Toxicity (Acute) | Yes | ISO 10993-11 | Extended contact duration requirement |
Systemic Toxicity (Subchronic) | No | - | Contact duration <30 days |
Implantation | No | - | Not an implantable device |
Hemocompatibility | No | - | No blood contact |
Genotoxicity | Optional | ISO 10993-3 | Consider due to silver nanoparticles |
Carcinogenicity | No | - | Contact duration <30 days |
How do I determine which biocompatibility tests are required for my device?
Can existing biocompatibility data reduce my testing requirements?
How does sterilization affect biocompatibility testing?
What should I do if my device contains novel materials?
How do I handle combination products with drug or biologic components?
What if my biocompatibility testing shows adverse results?