[Research on Reliability Design and Verification of CT Based on Clinical Application Data]

Area of Science:

• Medical Imaging Technology
• Product Reliability Engineering
• Clinical Data Analysis

Background:

• Clinical application data from medical X-ray computed tomography (CT) systems is crucial for understanding real-world performance.
• Translating this data into actionable product reliability requirements is a significant challenge in medical device development.

Purpose of the Study:

• To develop a method for transforming clinical application data into product reliability index requirements for medical CT.
• To demonstrate a closed-loop process from reliability requirements to design and verification using representative components.

Main Methods:

• Utilized clinical application data from Shanghai Sixth People's Hospital's medical CT systems.
• Defined reliability index requirements based on failure characteristics and clinical data.
• Applied the method to mechanical (patient table) and electronic (data control board) components.

Main Results:

• Established a complete set of closed-loop implementation methods for reliability engineering.
• Demonstrated the practical application of transforming clinical data into reliability requirements.
• Provided a framework for reliability design and verification informed by clinical usage.

Conclusions:

• The proposed method effectively bridges clinical data with product reliability engineering for medical CT.
• This approach enhances the reliability of medical devices by grounding design in actual clinical performance.
• The study offers a systematic pathway for improving medical CT product reliability through data-driven insights.