EN-285 is a European standard that sets guidelines for the sterilization of medical devices in healthcare facilities. When a person is expected to use EN-285 in a regulatory sense, they are required to adhere to the specific procedures and requirements outlined in the standard to ensure the effective sterilization of medical equipment.
This includes following the correct sterilization methods, monitoring parameters, documentation, and quality assurance measures as mandated by EN-285. One key parameter is the "time of sterilization," which determines the minimum duration for a load to be exposed at the sterilization temperature and saturated steam conditions to achieve the required level of energy transferred to the sterilized goods. Compliance with EN-285 is crucial for regulatory approval and proper sterilization of medical equipment in healthcare settings.
This parameter is validated using biological indicators (BIs) containing resistant microorganisms. BIs are placed in the sterilizer with the load, tested afterward for surviving microorganisms. EN-285 mandates a minimum sterilization time of three minutes at 121.1°C (250°F) for gravity displacement sterilizers and four minutes at 132°C (270°F, EN-285 actually lists three minutes @134°C) for pre-vacuum sterilizers.
- EN-285 sets requirements for temperature uniformity, steam quality, and sterilization duration. It is essential to monitor these factors together to confirm effective sterilization.
- Temperature: Steam temperature must reach a minimum of 121.1°C (250°F) for gravity displacement sterilizers and 134°C (270°F in most US applications) for pre-vacuum sterilizers.
- Steam Quality: High-quality steam is vital, free of non-condensable gases, with a pH between 5.5 and 8.5.
- Time of Sterilization: This must be sufficient to ensure steam reaches all load surfaces and eliminates microorganisms.
The Pass-Fail Report, integrated into the Common Reporting Tool, streamlines the process by utilizing a Time of Sterilization metric. This metric precisely denotes whether the conditions or criteria, including temperature, saturation, and steam quality, were satisfied between two sample intervals, ensuring alignment with EN-285 mandates. Though our products are designed for compliance with EN-285, the ultimate responsibility for compliance rests with you, the customer. Ensure you are familiar with and have done due diligence regarding EN-285.
The Time of Sterilization is a calculation that determines the total effective sterilization time. It combines the saturation criterion with the measured reference temperature. Time is considered as part of the sterilization process if the measured reference temperature matches or exceeds the required process temperature, and the saturation, expressed as the Temperature minus the calculated Saturation Temperature (T-Sat T), falls within the designated range.
You can establish both a minimum and maximum sterilization time criteria separately. The minimum time criterion is deemed "Passed" if the calculated time meets or exceeds the predefined criteria. Conversely, the maximum time condition "Passes" if the calculated time is equal to or falls below the predefined criteria. The max criterion can help to prevent adverse effects of the sterilization on the sterilized product. In cases where both the Min and Max fields are defined, the criterion "Passes" if the calculated time aligns with or falls within the specified range.
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