- When Combining Subchronic And Implantation Tests In One Project, What Factors Need To Be Considered, And How Can It Be Achieved?
- Under What Conditions Can The Extraction Liquid Of Dressings Be Accepted After PH Adjustment, Centrifugation, And Other Treatments? Should Samples Be Characterized Before And After Treatment, And What Key Indicators Should Be Focused On?
- How Is The Endotoxin Limit For Wound Dressing Products Determined?
- GB/T 16886.1-2022 Includes Implantation In The Biological Evaluation Of Dressings. How Should Implantation Tests For Dressings Be Conducted, And How Should Sampling (e.g., Hydrocolloid Dressings) And The Implantation Site Be Selected?
- Do All Medical Devices Require Chemical Characterization?
- What Factors May Affect Biocompatibility Risk When Using Biological Test Data From Similar Devices For Biological Evaluation?
- Can Products Made From Materials Conforming To YY 0341.1 Appendix B Be Exempted From Biological Evaluation?
- Why Is The Extraction Period Typically 24 Hours In China For Cytotoxicity Testing?
- What Are The Key Focus Areas In The Evaluation Of Acute, Subacute, Subchronic, And Chronic Toxicity, And Can These Tests Replace One Another? If A Product Has Undergone Acute Systemic And Subchronic Systemic Toxicity Tests, Can Subacute Systemic Toxicity Tests Be Waived? Under What Circumstances Is It Not Possible To Waive Subacute Systemic Toxicity Testing?
- GB/T 16886.11-2021 Adds Tests For Subchronic Systemic Toxicity Evaluation With Dual-route Exposure. Which Products Are Suitable For Dual-route Exposure, And Can Dual-route Exposure Methods Represent Subchronic Toxicity Under Polar And Non-polar Extraction Conditions?
- For Subchronic Systemic Toxicity Studied Via Implantation, What Is The Basis For Determining The Implantation Dose, And How Is The Conversion Between Animals And Humans Handled?
- How Should The Evaluation Of New Items In The Endpoint Table Be Considered After The Implementation Of The New GB/T 16886.1, And What Is The Background Of The ISO Revision?