ISO 15225:2010 医疗器械 质量管理 医疗器械的命名数据结构

标准编号：ISO 15225:2010

中文名称：医疗器械 质量管理 医疗器械的命名数据结构

英文名称：Medical devices — Quality management — Medical device nomenclature data structure

发布日期：2010-05

标准范围

ISO 15225:2010为医疗器械命名数据结构提供了规则和指南，以促进监管机构在国际层面上与相关方（如监管机构、制造商、供应商、医疗保健提供商和最终用户）之间的合作和数据交换。ISO 15225:2010包括最小数据集及其结构的指南。这些指南是为系统设计人员提供的，他们可以使用本文所述的命名系统建立数据库。ISO 15225:2010中包含的要求适用于医疗器械标识国际术语的开发和维护。ISO 15225:2010不包括作为数据文件提供的术语本身。

ISO 15225:2010 provides rules and guidelines for a medical device nomenclature data structure, in order to facilitate cooperation and exchange of data used by regulatory bodies on an international level between interested parties, e.g. regulatory authorities, manufacturers, suppliers, health care providers and end users.ISO 15225:2010 includes guidelines for a minimum data set and its structure. These guidelines are provided for system designers setting up databases that utilize the nomenclature system described herein.The requirements contained in ISO 15225:2010 are applicable to the development and maintenance of an international nomenclature for medical device identification.ISO 15225:2010 does not include the nomenclature itself, which is provided as a data file.

标准预览图