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Medical Translation: Chinese to English Verification Plan for Shelf Life of Medical Devices
Shelf life refers to the maximum period during which medical device products can maintain their performance specifications and functionality under specified storage conditions. This concept typically applies to single-use products, such as catheters and syringes.
I have translated a verification plan for the shelf life of a pressure balloon catheter consisting of over 4,600 words into English, including the following sections:
Purpose
Scope
Product Description
3.1. Product Name
3.2. Intended Use
3.3. Product Classification
3.4. Product Structure
3.5. Main Raw Materials
3.6. Sterilization Method
3.7. Sterilization Parameters
3.8. Packaging Method
3.9. Transportation Methods and Environment
3.10. Model Specifications
Verification Team Members and Responsibilities
Shelf Life Impact Analysis
Test Types and Conditions
6.1. Real-time Stability Testing
6.2. Real-time Stability Testing Conditions
6.3. Simulated Transportation
Sample Size and Test Items
7.1. Determination of Sample Size
7.2. Total Sample Size for Shelf Life
Acceptance Criteria and Testing Methods
8.1. Appearance and End Tip
8.2. Balloon Cross-section
8.3. Dimensions
8.4. Hydrophilicity
8.5. Peak Tensile Strength
8.6. No Leakage
8.7. Catheter Hub
8.8. Balloon Burst Pressure
8.9. Balloon Fatigue
8.10. Balloon Inflation and Deflation Time
8.11. Relationship Between Balloon Diameter and Inflation Pressure
8.12. Integrity of Hydrophilic Coating (Appearance)
8.13. Integrity of Hydrophilic Coating (Particle Shedding)
8.14. Friction of Hydrophilic Coating
8.15. Adhesion of Hydrophilic Coating
8.16. Simulated Use
8.17. Balloon Retraction
8.18. Insoluble Particles
8.19. Pulse Discharge Count
8.20. Electrical Safety
8.21. Sound Output Performance
8.22. Packaging Appearance
8.23. Packaging Seal Leakage
8.24. Packaging Seal Strength
8.25. Five Chemical Tests
8.26. Residue Levels of Ethylene Oxide and 2-Chloroethanol
8.27. Sterility
8.28. Bacterial Endotoxins
Sample Preparation
9.1. Sample Production
9.2. Sample Specifications and Quantities
9.3. Flowchart
Implementation Steps
Result Processing
Test Records
Conclusion
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