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

This part of ISO 15223 specifies a process for developing, selecting and validating symbols for inclusion inISO 15223-1.The purpose of this part of ISO 15223 is to ensure that symbols included in ISO 15223-1 are readilyunderstood by the target group.If the symbol validation process detailed in this part of ISO 15223 has been complied with, then the residualrisks, as defined in ISO 14971 and IEC 62366, associated with the usability of a medical device symbol arepresumed to be acceptable, unless there is objective evidence to the contrary.This part of ISO 15223 is not restricted to symbols intended to meet regulatory requirements or specified in regulatory guidelines on labelling.

标准预览图