ISO 15223-2-2010 医疗器械.用于医疗器械标签、作标记和提供信息的符号.第2部分:符号的制定、筛选和批准

标准号：ISO 15223-2-2010
中文标准名称：医疗器械.用于医疗器械标签、作标记和提供信息的符号.第2部分:符号的制定、筛选和批准
英文标准名称：Medical devices - Symbols to be used with medical device labels, labelling, and information to be supplied - Part 2: Symbol development, selection and validation
标准类型：C30
发布日期：1999/12/31 12:00:00
实施日期：1999/12/31 12:00:00
中国标准分类号：C30
国际标准分类号：01.080.20;11.040.01
引用标准：ISO 9186-1-2007;ISO 15223-1-2007;ISO 80416-2;IEC 80416-1-2008
适用范围：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.