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类别: QUALITY SYSTEMS
灭菌验证
建立灭菌过程持续生产无菌产品的记录过程。医疗器械必须按ISO 11135（EO）、ISO 11137（辐射）或ISO 17665（蒸汽）验证。
Last reviewed 2026-08-05 · Reviewed by MedFlux Editorial Board · Editorial policy
Expanded process notes below are currently maintained in English; the short definition above is localized. See our editorial policy.
WHEN IT APPLIES
Sterilization validation is required when a device is labeled sterile or when sterile barrier systems are critical to patient safety. Methods include ethylene oxide (EO), radiation, steam, and others validated to recognized standards.
PROCESS / STEPS
- Select method based on materials, bioburden, and packaging.
- Establish sterilization process parameters and SAL (typically 10⁻⁶ for terminally sterilized devices).
- Perform IQ/OQ/PQ and microbiological validation (e.g., half-cycle method for EO).
- Define routine monitoring, revalidation triggers, and residual limits where applicable.
EXAMPLES
- Single-use catheters often use EO sterilization with validated aeration and residual EO testing.
COMMON MISTAKES
- Changing packaging materials without revalidation.
- Ignoring worst-case load configurations in PQ.
RELATED GUIDES & TOOLS
SOURCES
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