Sterilization Methods Flashcards
7 cards from real CTBS practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Sterilization Methods flashcards as text
Which ISO standard specifically governs the development and validation of sterilization processes for medical devices and tissues?
Answer: ISO 11135 / ISO 11137
ISO 11135 covers ETO sterilization and ISO 11137 covers radiation sterilization validation for medical devices and tissue products.
A tissue bank is validating a new VHP (vaporized hydrogen peroxide) sterilization cycle. Which BI organism is most appropriate?
Answer: Geobacillus stearothermophilus
G. stearothermophilus is also used as the BI for VHP sterilization validation due to its high resistance to oxidizing agents.
When processing cortical bone with low-dose radiation, what adjunct method is often combined to achieve adequate sterility?
Answer: Aseptic processing techniques
Low-dose radiation is often combined with rigorous aseptic processing to achieve the required SAL while minimizing tissue damage.
The D-value in sterilization science refers to:
Answer: The time or dose required to reduce the microbial population by 90% (1 log)
The D-value (decimal reduction value) is the time or dose needed to reduce the viable microbial population by one log (90%).
Which property of ethylene oxide makes it effective as a sterilant at low temperatures?
Answer: It alkylates proteins and nucleic acids, disrupting cellular function
ETO is an alkylating agent that chemically modifies proteins and nucleic acids, rendering microorganisms non-viable without requiring high heat.
A tissue bank receives a BI result showing growth after a terminal sterilization run. The correct first action is:
Answer: Quarantine the lot and investigate immediately
A positive BI indicates a potential sterilization failure; the lot must be quarantined and a root-cause investigation initiated before any disposition decision.
What is the primary reason terminal sterilization is preferred over aseptic processing for allografts when feasible?
Answer: It provides a validated and measurable SAL guarantee
Terminal sterilization provides a mathematically defined and validated SAL, offering a higher and more reliable sterility assurance than aseptic technique alone.