After a positive biological indicator, the sterilizer is inspected, a probable cause is corrected, and testing resumes. What is generally required before the sterilizer returns to routine service?

Giải thích

Requalification after a failure or a major repair uses three consecutive empty-chamber cycles with negative biological indicators, with Bowie-Dick testing added for dynamic-air-removal sterilizers, to demonstrate the equipment is reliably performing again. A chemical indicator does not demonstrate microbial lethality, and one biological indicator in a production load is not sufficient evidence of restored performance. Operator observation is not a qualification method.