BS ISO 15223-2:2010规定了开发、选择和验证符号的过程，以包含在 ISO 15223-1。BS ISO 15223-2:2010的目的是确保ISO 15223-1中包含的符号易于识别 被目标群体理解。如果符合ISO 15223本部分详述的符号验证过程，则剩余 ISO 14971和IEC 62366中定义的与医疗器械符号可用性相关的风险包括: 推定为可接受，除非有相反的客观证据。 BS ISO 15223-2:2010不限于旨在满足监管要求或规范中规定的符号 标签监管指南。交叉引用:ISO 9186-1:2007ISO 15223-1:2007ISO 80416-2IEC 80416-1:2008ISO 7000ISO 7010ISO/TR 7239ISO 14971ISO 15225IEC 60417-DBIEC/TR 60878IEC 80416-3EN 980IEC 62366购买本文件时提供的所有当前修订版均包括在内。

BS ISO 15223-2:2010 specifies a process for developing, selecting and validating symbols for inclusion in ISO 15223-1.The purpose of BS ISO 15223-2:2010 is to ensure that symbols included in ISO 15223-1 are readily understood by the target group.If the symbol validation process detailed in this part of ISO 15223 has been complied with, then the residual risks, as defined in ISO 14971 and IEC 62366, associated with the usability of a medical device symbol are presumed to be acceptable, unless there is objective evidence to the contrary.BS ISO 15223-2:2010 is not restricted to symbols intended to meet regulatory requirements or specified in regulatory guidelines on labelling.Cross References:ISO 9186-1:2007ISO 15223-1:2007ISO 80416-2IEC 80416-1:2008ISO 7000ISO 7010ISO/TR 7239ISO 14971ISO 15225IEC 60417-DBIEC/TR 60878IEC 80416-3EN 980IEC 62366All current amendments available at time of purchase are included with the purchase of this document.