标准编号：ISO 15225:2016
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：2016-03
标准范围
This International Standard specifies rules and guidelines for a medical device nomenclature datastructure, in order to facilitate cooperation and exchange of data used by regulatory bodies on aninternational 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. Theseguidelines are provided for system designers setting up databases that utilize the nomenclature systemdescribed herein.The requirements contained in this International Standard are applicable to the development andmaintenance of an international nomenclature for medical device identification.This International Standard does not include the nomenclature itself, which is provided as a separatedata file.
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