YY/T 0468-2015 in English
VALIDMedical devices―Quality management―Medical device nomenclature data structure
- Issued on:2015-03-02
- Implemented on:2016-01-01
- File Format:PDF
- Delivery:Via email within 5 business days
$301.00
本标准代替YY/T 0468-2003《命名 用于管理资料交流的医疗器械命名系统规范》。
本标准规定了医疗器械术语系统数据结构的规则和指南,以促进国际范围内医疗器械数据信息的交换。
本标准适用于提供和交换医疗器械产品信息。
Scope
This standard provides rules and guidance for the structure of medical device terminology system data to facilitate the international communication of data used by regulatory agencies between interested parties (e.g. regulatory agencies, manufacturers, suppliers, health care organizations and end users). exchange and cooperation. This standard includes guidance on minimum data groups and their structure. These guidelines are provided to enable system designers to build databases using the terminology described here. This standard contains requirements that may be used to establish and maintain an international terminology system for the identification of medical devices. This standard does not cover the terminology system itself, which is provided as a data file.

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