EN 285 Sterilization – Steam sterilizers – Large sterilizers – This European Standard specifies requirements and the relevant tests for large steam sterilizers primarily used in health care for the sterilization of medical devices and their accessories contained in one or more sterilization modules. The test loads described in this European Standard are selected to represent the majority of loads (i.e. wrapped goods consisting of metal, rubber and porous materials) for the evaluation of general purpose steam sterilizers for medical devices. However, specific loads (e.g. heavy metal objects or long and/or narrow lumen) will require the use of other test loads. This European Standard applies to steam sterilizers designed to accommodate at least one sterilization module or having a chamber volume of at least 60 l. Large steam sterilizers can also be used during the commercial production of medical devices. This European Standard does not specify requirements for equipment intended to use, contain or be exposed to flammable substances or substances which could cause combustion. This European Standard does not specify requirements for equipment intended to process biological waste or human tissues. This European Standard does not describe a quality management system for the control of all stages of the manufacture of the sterilizer. NOTE 1 Attention is drawn to the standards for quality management systems e.g. EN ISO 13485. NOTE 2 Environmental aspects are addressed in Annex A.

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EN 285 is a European standard that pertains to the sterilization of medical devices. Specifically, it deals with steam sterilizers, particularly large sterilizers used in healthcare facilities. The standard outlines requirements and testing methods for steam sterilizers to ensure the effectiveness of the sterilization process and the safety of the medical devices being sterilized.

Some key aspects covered by EN 285 include:

1. Design and Construction: The standard sets forth requirements for the design and construction of steam sterilizers to ensure they meet safety and performance standards.
2. Operating Parameters: EN 285 specifies parameters such as temperature, pressure, and cycle times that must be adhered to during the sterilization process to achieve effective sterilization.
3. Validation and Verification: The standard outlines procedures for validating and verifying the performance of steam sterilizers, including testing methods and documentation requirements.
4. Biological Indicators: It provides guidance on the use of biological indicators to monitor the effectiveness of the sterilization process.
5. Quality Management: EN 285 emphasizes the importance of quality management systems in ensuring the consistent and reliable sterilization of medical devices.
6. Safety Requirements: Safety considerations are paramount in the standard, covering aspects such as pressure vessel safety, control systems, and emergency procedures.

Compliance with EN 285 is essential for healthcare facilities to ensure that steam sterilizers are effectively sterilizing medical devices and thereby contributing to patient safety. Manufacturers of steam sterilizers must ensure their products meet the requirements outlined in the standard to obtain certification and market their devices in Europe.