Medical Device Reliability and Associated Areas

摘要: INTRODUCTION Historical Developments Need of Reliability in Medical Devices Device Related Facts and Figures Government control Liability Recalls Equipment Classification Associated Areas Terms Definitions BASIC RELIABILITY MATHEMATICS AND CONCEPTS FOR MEDICAL DEVICES Basic Law Boolean Algebra Probability Distributions for Time to Failure Configurations Aerospace Comparisons Guidelines reliability Professional Working Health Care TOOLS DEVICE ASSURANCE Mode Effect analysis (FMEA) Fault Tree Analysis (FTA) Rate Evaluation Parts Count Methods Markov Method Common-Cause HUMAN ERROR IN HEALTH CARE SYSTEMS Facts, Figures, Example on Human Error Systems Causes Patient Injuries Accident with High Occurrence Anesthesia most Frequent Incidents, Factors, Operator Errors General Approach Factors Development Process Reduce useful the Reducing Device/Equipment User Interface SOFTWARE QUALITY Software Hardware versus Failures Classifications Specification Framework Define Quality Assurance Program a Company Cardioplegia Delivery System Important Issues Safety Cardiac-Rhythm-Management Products Design, Coding, Testing, Metrics Modeling SAFETY Types Essential Requirements Legal Aspects Life Cycle Estimation Cost Models RISK ASSESSMENT CONTROL Risk Management, Definitions, Steps Assessment Integrating Design Control Affecting Values Consequences Data Regulatory Compliance Total Management Tools Assuring Indices TESTING Test Plan Information Tests Accelerated Testing Success Mean between (MTBF) Calculation Confidence Limits MBF Publications COSTING Reason Costing Economic Making Investment Decisions Formulas Determining Value Money Useful MAINTENANCE MAINTAINABILITY Repair Maintenance Computerized its Selection Ventilator Field Performance medical Maintainability Measures RELATED STANDARDS, FAILURE DATA SOURCES, ANALYSIS What is Standard? Organizations Involved Standards other Documents Names Addresses Directly or Indirectly Standard/Other Sources Appendix Each chapter also contain problems references