scope:

This document 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 document 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 document 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 document does not specify requirements for large steam sterilizers intended to use, contain or be exposed to flammable substances or substances which could cause combustion. This document does not specify requirements for equipment intended to process biological waste or human tissues.

This document 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.