標準號：BS EN 13060-2005
中文標準名稱：小型蒸汽滅菌器
英文標準名稱：Small steam sterilizers
標準類型：C47
發布日期：2005/8/3 12:00:00
實施日期：2005/8/3 12:00:00
中國標準分類號：C47
國際標準分類號：11.080.10
適用范圍：This European Standard specifies the performance requirements and test methods for small steam sterilizers andsterilization cycles which are used for medical purposes or for materials that are likely to come into contact withblood or body fluids.This European Standard applies to automatically controlled small steam sterilizers that generate steam usingelectrical heaters or use steam that is generated by a system external to the sterilizer.This European Standard applies to small steam sterilizers used primarily for the sterilization of medical devices andunable to accommodate a sterilization module (300 mm × 300 mm × 600 mm) and with a chamber volume notexceeding 60 litres.This European Standard does not apply to small steam sterilizers that are used to sterilize liquids orpharmaceutical products.This European Standard does not specify safety requirements related to risks associated with the zone in which thesterilizer is used (e.g. flammable gases).This European Standard does not specify requirements for the validation and routine control of sterilization by moistheat.NOTE Requirements for the validation and routine control of sterilization by moist heat are given in EN 554, which mayalso be applied for small steam sterilizers.