1.1 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 sterilizer 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.
Large steam sterilizers can also be used during the commercial production of medical devices.
1.2 This European Standard is not applicable to steam sterilizers designed to process a size of load less than
one sterilization module or having a chamber volume less than 60 l.
1.3 This European Standard does not describe a quality assurance system for the control of all stages of the
manufacture of the sterilizer.
NOTE Attention is drawn to the standards for quality management systems e.g. EN ISO 13485.
1.4 Planning and design of products applying to this European Standard should consider the environmental
impact from the product during its life cycle. Environmental aspects are addressed in Annex A.
NOTE Additional aspects of environmental impact are addressed in EN ISO 14971.