EN 285 Sterilization - Steam Sterilizers - Large Sterilizers

EUROLAB laboratory provides testing and compliance services within the scope of EN 285 standard. This European standard specifies the requirements and related tests for large steam sterilizers used primarily in healthcare for the sterilization of medical devices and their accessories contained in one or more sterilization modules.

The test loads described in this European standard have been chosen to represent most of the loads (i.e. packaged products made of metal, rubber and porous materials) for the evaluation of general purpose steam sterilizers for medical devices. However, certain loads (eg heavy metal objects or long or narrow lumens) will require the use of other test loads.

This European standard applies to steam sterilizers designed to accommodate at least one sterilization module or with 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 materials or substances capable of causing combustion.

This European standard does not specify requirements for equipment for processing biological waste or human tissues. This European standard does not define a quality management system for the control of all stages of manufacture of the sterilizer.

EUROLAB assists manufacturers with EN 285 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.