The safety and effectiveness of the medical devices are the primary consideration when it comes to product registration. According to the international standard ISO 10993-1, the biological evaluation of the medical device is based on nature and duration of their anticipated contact with human tissues when in use and indicates.

To make sure the safety tests data are true and traceability, biocompatibility tests should be conducted under a laboratory quality system compliant to ISO/IEC 17025 or an equivalent standard such as GLP. All the study was performed in accordance with the agreed protocol and recorded in the report to provide the true and accurate results.