標準號：DIN EN 285-2009
中文標準名稱：滅菌.蒸汽滅菌器.大型滅菌器(包括修改件A2-2009).英文版本DIN EN 285-2009-08
英文標準名稱：Sterilization - Steam sterilizers - Large sterilizers (includes Amendment A2:2009); English version of DIN EN 285:2009-08
標準類型：C46
發布日期：1999/12/31 12:00:00
實施日期：1999/12/31 12:00:00
中國標準分類號：C46
國際標準分類號：11.080.10
引用標準：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;EN 60751-1995;EN 61010-1;EN 61010-2-040;EN 61326-1997;EN 61672-1-2003;EN 61672-2-2003;EN ISO 3746-1995;EN ISO 4017
適用范圍：1.1 This European Standard specifies requirements and the relevant tests for large steam sterilizers primarilyused in health care for the sterilization of medical devices and their accessories contained in one or moresterilization modules. The test loads described in this European Standard are selected to represent the majority ofloads (i.e. wrapped goods consisting of metal, rubber and porous materials) for the evaluation of general purposesteam sterilizer for medical devices. However, specific loads (e.g. heavy metal objects or long and/or narrowlumen) 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 thanone sterilization module or having a chamber volume less than 60 I.1.3 This European Standard does not describe a quality assurance system for the control of all stages of themanufacture 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 environmentalimpact 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.