DIN EN 13795-2011 患者,临床医务人员和医疗设备作为医疗器材使用的手术用布帘,睡衣和超净套装.制造商,处理机和产品的一般要求,试验方法,性能要求和性能等级.德文版本EN 13795-2011
Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - General requirements for manufacturers, processors and products, test methods, performance requirements and performance levels; German version
This standard gives information on the characteristics of single-use and reusable surgical gowns, surgical drapes and clean air suits used as medical devices for patients, clinical staff and equipment, intended to prevent the transmission of infective agents between patients and clinical staff during surgical and other invasive procedures. This standard specifies test methods for evaluating the identified characteristics of surgical drapes, gowns and clean air suits and sets performance requirements for these products.