BS EN 285:2015 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 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 European Standard 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 European Standard 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 European Standard does not specify requirements for equipment intended to process biological waste or human tissues.

This European Standard 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.


Cross References:
EN 764-7:2002
EN 867-5:2001
EN 1041:2008+A1:2013
EN 13445-1:2014
EN 13445-2:2014
EN 13445-3:2014
EN 13445-4:2014
EN 13445-5:2014
EN 13445-8:2014
EN 14222:2003
EN 22768-1:1993
ISO 2768-1:1989
EN 60204-1:2006
IEC 60204-1:2005
EN 60584-1:2013
IEC 60584-1:2013
EN 60751:2008
IEC 60751:2008
EN 60770-1:2011
IEC 60770-1:2011
EN 61010-1:2010
IEC 61010-1:2010
EN 61010-2-040:2005
IEC 61010-2-040:2005
EN 61326-1:2013
IEC 61326-1:2012
EN ISO 228-1:2003
ISO 228-1:2000
EN ISO 3746:2010
ISO 3746:2010
EN ISO 11140-3:2009
ISO 11140-3:2007
EN ISO 12100:2010
ISO 12100:2010
EN ISO 13408-2:2011
ISO 13408-2:2003
EN 547-1:1996+A1:2008
EN 547-2:1996+A1:2008
EN 547-3:1996+A1:2008
EN 556-1:2001
EN 764-1:2004
EN 868
EN 1717:2000
EN 1837
EN 10088-2
EN 10088-3
EN 12953
EN 13060
EN 13445
EN 61032:1998
IEC 61032:1997
EN 61140
IEC 61140
EN 61508
IEC 61508
EN 61508-1
IEC 61508-1
EN 62061
IEC 62061
EN 62304
IEC 62304
EN 62366
IEC 62366
EN ISO 3740
ISO 3740:2000
EN ISO 4017
ISO 4017
EN ISO 9000:2005
ISO 9000:2005
EN ISO 11140-1:2009
ISO 11140-1:2005
EN ISO 11140-4:2007
ISO 11140-4:2007
EN ISO 11607-1
ISO 11607-1
EN ISO 13485:2012
ISO 13485:2003
EN ISO 13732-1
ISO 13732-1
EN ISO 14050:2010
ISO 14050:2009
EN ISO 14738:2008
ISO 14738:2002
EN ISO 14937
ISO 14937
EN ISO 14971:2012
ISO 14971:2007
EN ISO 15223-1:2012
ISO 15223-1:2012
EN ISO 15883-1:2009
ISO 15883-1:2006
EN ISO 17665-1:2006
ISO 17665-1:2006
CEN ISO/TS 17665-2:2009
ISO/TS 17665-2:2009
EN ISO/IEC 17025:2005
ISO/IEC 17025:2005
ISO 8573-1:2010
ISO/TS 11139:2006
93/42/EEC
2014/68/EU
2003/10/EC
2006/42/EC


All current amendments available at time of purchase are included with the purchase of this document.