ISO 10993-10 for Skin Sensitization
Medical grade adhesives, sealants, coatings, and potting or encapsulation compounds used in contact with the body must be compatible and safe for their intended use. One of the key safety assessments required for this is the evaluation of potential skin sensitization.
ISO 10993-10 tests were conducted by a prominent independent testing laboratory and confirm that extracts of the products listed below are in full compliance with this standard. Specifically, they did not cause any skin reactions and are considered "non-sensitizers" to the skin of guinea pigs, meeting the requirements of the GPMT (Guinea Pig Maximization Test) outlined in the ISO 10993-10:2021 guidelines.
Key Application Areas for ISO 10993-10 Certified Products
- Wearable Devices
- Catheters and Tubings
- Surgical Tools and Instruments
- Patient Monitoring Equipment & Medical Tables
Master Bond Products Meeting ISO 10993-10
The following product has been confirmed as a Non-sensitizer per ISO 10993-10:2021:
| Product | Description |
|---|---|
| Two part epoxy with strong heat resistance and good electrical insulation |
Note: These results are intended as a guideline and don't guarantee FDA approval. Users are responsible for obtaining FDA clearance for their specific applications, and we recommend independent verification of our test results.
Related Certifications
Master Bond offers medical-grade systems tested to multiple biocompatibility standards:
- ISO 10993-5 – Cytotoxicity (cell toxicity screening)
- USP Class VI – Systemic toxicity, intracutaneous reactivity, and implantation testing
For more information on Master Bond sterilization resistant adhesives, please click here.
