BS EN 13795-2:2019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。交叉引用:EN ISO 22612:2005ISO 9073-10:2003ISO 22612:2005EN ISO 139:2005EN ISO 11737-1:2018ISO 13938-1:1999ISO 11737-1:2018ISO 10993-1:2009ISO 139:2005ISO 139:2005/AMD 1:2011EN ISO 10993-1:2009EN ISO 9073-10:2004EN 29073-3:1992EN ISO 13938-1:1999ISO 11607-2ISO 11693-10ISO 11092EN ISO 11677-1EN ISO 9293-10EN ISO 10993-10EN ISO 1096593-11767ENISO 13485ISO 13485ISO 10993-5EN ISO 15223-1ISO 15223-1ISO 9237EN ISO 11092EN ISO 11607- 2替换BS EN 13795:2011+A1:2013，其保持当前状态。购买本文件时，所有当前可用的修订均包含在购买本文件中。

BS EN 13795-2:2019 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.Cross References:EN ISO 22612:2005ISO 9073-10:2003ISO 22612:2005EN ISO 139:2005EN ISO 11737-1:2018ISO 13938-1:1999ISO 11737-1:2018ISO 10993-1:2009ISO 139:2005ISO 139:2005/AMD 1:2011EN ISO 10993-1:2009EN ISO 9073-10:2004EN 29073-3:1992EN ISO 13938-1:1999ISO 11607-2ISO 10993-10ISO 11092EN ISO 15797ISO 11607-1EN ISO 9237EN ISO 10993-10EN ISO 10993-5EN ISO 11607-1EN 1041ISO 15797EN 14065EN 62366EN ISO 13485ISO 13485ISO 10993-5EN ISO 15223-1ISO 15223-1ISO 9237EN ISO 11092EN ISO 11607-2Replaces BS EN 13795:2011+A1:2013 which remains currentAll current amendments available at time of purchase are included with the purchase of this document.