scope:

Specifies requirements and the relevant tests for large steam sterilizers primarily used in health care for the sterilization of one or more sterilization modules for wrapped goods (instruments etc. and porous loads). Large steam sterilizers can also be used during the commercial production of medical devices. Sterilizers conforming to this standard can offer a single automatic sterilization cycle or a number of selectable automatic sterilization cycles, e.g. with different operating temperatures. Is not applicable to small steam sterilizers nor to steam sterilizers used for the sterilization of pharmaceutical products in containers. The use of sterilizers for unwrapped instruments and utensils for immediate use in aseptic areas and for fluid-sterilizers will be the subject of a separate standard. Does not describe a quality asssurance system for the control of all stages of the manufacture of the sterilizer. Attention is drawn to the standards for quality systems (see EN ISO 9001, EN ISO 9002, EN ISO 9004-1 and EN 46001 and EN 46002).