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.
Related directives
NOTE: If the word "harmonized" (marked in green) is not found in the field with the name of the directive, it means that the European standard is not cited in the OJEU.
Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
