BS EN ISO 15225:2016规定了医疗器械命名数据的规则和指南 结构，以促进监管机构在 相关方之间的国际层面，例如监管机构、制造商、供应商， 医疗保健提供者和最终用户。本国际标准包括最小数据集及其结构的指南。这些 为系统设计师提供了使用命名系统建立数据库的指南 如本文所述。本国际标准中包含的要求适用于 维护医疗器械识别的国际术语。本国际标准不包括术语本身，术语本身作为单独的标准提供 数据文件。交叉引用:ISO/IEC 8859-1:1998 ISO 1087- 1:2000ISO 1942ISO/IEC 2382:2015ISO 25964-1:2011ISO 25964-2:2013ISO 4135ISO 999ISO 10241-1IEC 6060190/385/EEC93/42/EEC98/79/ECENV 12611购买本文件时提供的所有当前修订版均包含在购买本文件中。

BS EN ISO 15225:2016 specifies 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, healthcare providers and end users.This International Standard 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 this International Standard are applicable to the development and maintenance of an international nomenclature for medical device identification.This International Standard does not include the nomenclature itself, which is provided as a separate data file.Cross References:ISO/IEC 8859-1:1998ISO 1087-1:2000ISO 1942ISO/IEC 2382:2015ISO 25964-1:2011ISO 25964-2:2013ISO 4135ISO 9999ISO 10241-1IEC 6060190/385/EEC93/42/EEC98/79/ECENV 12611All current amendments available at time of purchase are included with the purchase of this document.