本欧洲标准适用于体外诊断医疗器械（IVD MD）的性能评估，包括用于自检的IVD MD。它规定了制造商对绩效评估研究的规划，进行，评估和记录的责任和一般要求。它不适用于某些IVD MD或特定用途的具体评估计划。 注:有关具体评估计划的一些出版物，请参阅参考书目。 在制造商维护质量体系的情况下，该标准解决了符合EN ISO 9001，EN 46001和EN 928中描述的“设计验证”和“设计变更”，特别是考虑到IVD MD的性质和用途。 特别地，本标准适用于IVD MD - 根据制造商要求的IVD MD执行的绩效评估结果，向受理机构和国家当局提供证据， - 建立源自适当研究或由现有文献产生的足够的绩效评估数据 - 满足设计验证的质量体系要求

This European Standard applies to the performance evaluation of in vitro diagnostic medical devices (IVD MDs) including IVD MDs for self-testing. It specifies the responsibilities and general requirements for the planning, conduct, assessment and documentation of a performance evaluation study by the manufacturer. It does not apply to specific evaluation plans for certain IVD MDs or a specific use. NOTE For a selection of publications on specific evaluation plans see Bibliography. Where a manufacturer maintains a quality system this standard addresses the compliance with "design validation" and "design changes" as described in EN ISO 9001, EN 46001 and EN 928 especially considering the nature and use of IVD MDs. In particular, this standard applies to IVD MDs to - show evidence to notified bodies and national authorities by results of a performance evaluation that the IVD MD performs as claimed by the manufacturer, - establish adequate performance evaluation data originating from appropriate studies or resulting from available literature, and to - satisfy the requirements of a quality system for design validation.