BS EN 13795-1:2019规定了除以下信息外，还应向用户和第三方验证者提供的信息: 医疗器械的常规标签（见EN 1041和EN ISO 15223-1），涉及制造和维护 处理要求。本文件介绍了一次性使用和一次性使用的特点 可重复使用的手术服和手术帘，用作患者、临床工作人员和医生的医疗设备 用于防止临床工作人员和患者之间传染的设备 在外科手术和其他侵入性手术中。本文件规定了评估试验结果的试验方法 确定了手术窗帘和手术服的特点，并为其设定了性能要求 产品。交叉引用:EN ISO 22612:2005EN 29073-3:1992 EN ISO 13938-1:1999ISO 9073-10:2003ISO 139:2005/AMD 1:2011EN ISO 9073-10:2004ISO 11737-1:2018EN ISO 10993-1:2009ISO 22610:2006 Ed 1EN ISO 811: 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 ISO ISO ISO ISO ISO ISO ISO ISO 2009 2009 2009 2009 ISO ISO ISO ISO ISO ISO ISO ISO 2009 2009 2009 2009 ISO ISO ISO ISO ISO 2009 2009 2009 2009 ISO ISO ISO ISO 2009 2009 2009 2009 2009 2009 ISO ISO ISO ISO ISO ISO 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 ISO ISO ISO ISO ISO ISO ISO ISO ISO ISO ISO ISO 2009 2009 2009 2009 2009 2009 2009 2009 2009 ISO ISO ISO ISO ISO ISO ISO 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 ISO ISO ISO ISO ISO ISO ISO 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 ISO ISO ISO ISO ISO ISO 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 ISO ISO ISO ISO ISO ISO 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 ISO ISO ISO ISO ISO ISO ISO 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 2009 ISO ISO ISO ISO ISO ISO ISO 2009 ISO 10993-5EN ISO 13485EN ISO 10993-5EN ISO 11810ENISO 15797 ISO 15797ISO 9073-12ISO 11810EN ISO 9073-6取代了BS EN 13795:2011+A1:2013，该标准仍然有效。购买本文件时，所有当前可用的修订版均包含在购买本文件中。

BS EN 13795-1:2019 specifies information to be supplied to users and third party verifiers in addition to the usual labelling of medical devices (see EN 1041 and EN ISO 15223-1), concerning manufacturing and processing requirements. This document gives information on the characteristics of single-use and reusable surgical gowns and surgical drapes used as medical devices for patients, clinical staff and equipment, intended to prevent the transmission of infective agents between clinical staff and patients during surgical and other invasive procedures. This document specifies test methods for evaluating the identified characteristics of surgical drapes and gowns and sets performance requirements for these products.Cross References:EN ISO 22612:2005EN 29073-3:1992EN ISO 13938-1:1999ISO 9073-10:2003ISO 139:2005/AMD 1:2011EN ISO 9073-10:2004ISO 11737-1:2018EN ISO 10993-1:2009ISO 22610:2006 Ed 1EN ISO 811:2018EN ISO 139:2005ISO 10993-1:2009EN ISO 11737-1:2018ISO 22612:2005ISO 811:2018EN ISO 22610:2006ISO 13938-1:1999ISO 139:2005ISO 9073-6EN ISO 11607-1ISO 15223-1EN ISO 9237EN 62366ISO 13485EN ISO 11092ISO 9237EN ISO 10993-10ISO 9073-11ISO 11092EN ISO 9073-12EN 1041EN ISO 15223-1EN 14065ISO 11607-2EN ISO 11607-2EN ISO 9073-11ISO 11607-1ISO 10993-10ISO 10993-5EN ISO 13485EN ISO 10993-5EN ISO 11810EN ISO 15797ISO 15797ISO 9073-12ISO 11810EN ISO 9073-6Replaces BS EN 13795:2011+A1:2013 which remains currentAll current amendments available at time of purchase are included with the purchase of this document.