标准摘要
[中文适用范围]： ISO 15223 的这一部分指定了开发、选择和验证包含在 ISO 15223-1 中的符号的流程。 ISO 15223 这部分的目的是确保目标群体易于理解 ISO 15223-1 中包含的符号。 如果已遵守 ISO 15223 本部分中详述的符号验证流程，则 ISO 14971 和 IEC 62366 中定义的与医疗器械符号的可用性相关的残余风险被认为是可接受的，除非有客观的要求相反的证据。 ISO 15223 的这一部分不限于旨在满足监管要求或标签监管指南中指定的符号。 [外文原描述]： 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.
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