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Section
Number
Top Level Hazard & Cause
Effect & Harm / Hazard related use scenario
Pre Control Severity
Pre Control Probability
Design Mitigation
Design Verification Plan
Manufacturing and/or other Control
Manufacturing Verification Plan
Post Control Severity
Post Control Probability
Post Control Risk
Pre Control Risk
Low as Possible and Acceptable
Severity rating
8- Requirements for Sterility
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No
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