ISO 15223-2:2010 医疗设备 与医疗设备标签、标记以及所提供信息一起使用的符号 第2部分：符号的开发、选择和确认

标准编号：ISO 15223-2:2010

中文名称：医疗设备 与医疗设备标签、标记以及所提供信息一起使用的符号 第2部分：符号的开发、选择和确认

英文名称：Medical devices — Symbols to be used with medical device labels, labelling, and information to be supplied — Part 2: Symbol development, selection and validation

发布日期：2010-01

标准范围

ISO 15223-2:2010规定了开发、选择和验证ISO 15223-1中包含的符号的过程。ISO 15223-2:2010的目的是确保目标群体容易理解ISO 15223-1中包含的符号。如果符合ISO 15223-2:2010中详述的符号验证过程，则ISO 14971和IEC 62366中定义的与医疗器械符号可用性相关的剩余风险被认为是可接受的，除非有相反的客观证据。ISO 15223-2:2010不限于旨在满足监管要求或标签监管指南中规定的符号。

ISO 15223-2:2010 specifies a process for developing, selecting and validating symbols for inclusion in ISO 15223-1.The purpose of 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 ISO 15223-2:2010 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.ISO 15223-2:2010 is not restricted to symbols intended to meet regulatory requirements or specified in regulatory guidelines on labelling.

标准预览图