2026–2027 | Detailed Answers & Exam Review
Qualification - correct answers -Testing that assesses the performance of a steam sterilizer in the
environment in which it will be used before the equipment is approved for routine use in the healthcare
facility.
Validation - correct answers -Documented procedures performed by a medical device manufacturer to
establish that a process consistently yields a product complying with predetermined specifications.
Verification - correct answers -Documented procedures performed in the users environment to
establish that predetermined specifications have been met.
Lot (load) control number - correct answers -Number and /or letters by which a specific group of
products can be traced to a particular manufacturing or sterilization operation.
Extended cycle - correct answers -Sterilization cycles that fall outside of the traditional cycles used in the
Central Service department because exposure times exceed standard steam sterilization times.
Wet pack - correct answers -Trays/containers containing moisture after the sterilization process is
complete
Biobarrier - correct answers -A package system that allows a sterilant to enter a pack and after
sterilization, creates a barrier to contamination.
1