EVS-EN 285:2015+A1:2021

EN 285 specifies requirements and the relevant tests for large steam sterilizers primarily used in health care for the sterilization of medical devices. The test loads described in EN 285 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. However, specific loads (e.g. heavy metal objects or long and/or narrow lumen) will require the use of other test loads.

EN 285 applies to steam sterilizers designed to accommodate at least one sterilization module or have a chamber volume of at least 60 l. Large steam sterilizers can also be used during the commercial production of medical devices.

It does not specify requirements for equipment intended to use, contain or be exposed to flammable substances or substances which could cause combustion and requirements for equipment intended to process biological waste or human tissues. This standard does not describe a quality management system for the control of all stages of the manufacture of the sterilizer.