医疗器械使用期限
2025-12-08 19:51:22 0 举报医疗器械使用期限流程图
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Analyze the influencing factors of key components
Path 1
b. Frequency and intensity of use
Post market data from the products or similar products(Failure rate/Compliant rate...)
g. if any more.? ..
Evaluation path selectionPath 1 or Path 2 ?
f. Component maintenance and repair status
Conduct accelerated aging tests on products/key components
e. Packaging and sterilization
end
d. cleaning and disinfection
Decompose into subsystem/component evaluation
Path 2
a. Key componnets malfunction
Formulate an evaluation report
Conduct product verification directly
Start of usefullife evaluation
Analysis
usefullife timepre-define
influencing factors
Conduct real-time/accelerated aging tests
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