BS EN 285:2006+A2:2009 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.

BS EN 285:2006+A2:2009 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.

BS EN 285:2006+A2:2009 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.

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.



Cross References:
EN 764-1:2004
EN 867-3
EN 867-5
EN 868-5
EN 1822
EN 10088-1
EN 10088-3
EN 12953
EN 13445
EN 14222
EN 60584-2:1993
IEC 60584-2:1982
IEC 60584-2:1982/AMD 1:1989
EN 60751:1995
IEC 60751:1983
IEC 60751:1983/AMD 1:1986
EN 61010-1
IEC 61010-1:2001
EN 61010-2-040
IEC 61010-2-040:2005
EN 61326:1997
IEC 61326:1997
EN 61672-1:2003
IEC 61672-1:2002
EN 61672-2:2003
IEC 61672-2:2003
EN ISO 3746:1995
ISO 3746:1995
EN ISO 4017
ISO 4017:1999
EN 554:1994
EN 556-1:2001
EN 573-3
EN 573-4
EN 866-1:1997
EN 867-4
EN 868-1
EN 868-2
EN 868-3
EN 868-4
EN 868-6
EN 868-7
EN 868-8
EN 868-9
EN 868-10
EN 1562
EN 1652
EN 1653
EN 1717
EN 1982
EN 10025
EN 10088-2
EN 10095
EN 12449
EN 12451
EN 13060
EN 60204-1
IEC 60204-1:1997
EN ISO 228-1
ISO 228-1:2000
EN ISO 10012
ISO 10012:2003
EN ISO 11140-1
ISO 11140-1:2005
EN ISO 13485
ISO 13485:2003
EN ISO 14161
ISO 14161:2000
EN ISO 14937
ISO 14937:2000
EN ISO 14971
ISO 14971:2000
ISO/TS 11139:2001
ISO 13683:1997
prEN ISO 17665
ISO/DIS 17665:2004
VIM:1993
97/23/EC
93/42/EEC
2006/42/EC


Incorporates the following:
Amendment, June 2008. Amends and replaces BS EN 285:2006. Amendment, January 2010. Amends and replaces BS EN 285:2006+A1:2008