标准号：EN 13795-2011
实施状态：现行
中文名称：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
英文名称：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 (Incorporates Amendment A1: 2013)
发布日期：2011-03-01
被替代标准：EN 13795+A1-2013
标准简介：This European Standard specifies information to be supplied to users and third party verifiers in addition to the usual labelling of medical devices (see EN 980 and EN 1041), concerning manufacturing and processing requirements.This European 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 European Standard specifies test methods for evaluating the identified characteristics of surgical drapes, gowns and clean air suits and sets performance requirements for these products. EN 13795 does not cover requirements for flammability of products. Suitable test methods for flammability and resistance to penetration by laser radiation, together with an appropriate classification system, are given in EN ISO 11810-1 and EN ISO 11810-2. Additional essential requirements that apply to surgical clothing and drapes are covered by other European Standards.
文件格式：PDF
文件大小：1.05MB
文件页数：26
（以上信息更新时间为：2019-11-28）
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.pdf
(1.05 MB)
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