EN 285 and ISO 17665

EN 285 covers large steam sterilizers; ISO 17665 covers the development, validation and routine control of moist heat sterilization. Key tests: the daily Bowie-Dick (air removal and steam penetration), the vacuum leak test (EN 285 clause 18: within the manufacturer's limit and never above 1.3 mbar/min), and the thermometric test with sensors in the load and the drain: equilibration time at most 15 s for chambers up to 800 L, and holding the sterilization band for the set time (in the UK, HTM 01-01 Part C sets the band and hold for porous loads). Steam quality (non-condensable gases, superheat, dryness) is part of validation.

A summary written by BMEssentia for learning, not the text of the standard. Always work from the current official edition and the manufacturer's instructions.