BS EN 13060-2005 小型蒸汽灭菌器

标准号：BS EN 13060-2005
中文标准名称：小型蒸汽灭菌器
英文标准名称：Small steam sterilizers
标准类型：C47
发布日期：2005/8/3 12:00:00
实施日期：2005/8/3 12:00:00
中国标准分类号：C47
国际标准分类号：11.080.10
适用范围：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.