Standard No.:	YY/T 0468-2015
Chinese Name:	医疗器械 质量管理 医疗器械术语系统数据结构
English Name:	Medical devices—Quality management—Medical device nomenclature data structure
Professional Classification:	C31 General and microsurgical devices
Professional Classification:	YY Professional Standard - Pharmaceutics
ICS Classification:	11.040.01 Medical equipment in general 35.240.80 IT applications in health care technology
Issued by:
Issued on:	2015-03-02
Implemented on:	2016-01-01
Status:	VALID
Replace:	YY/T0468-2003 Nomenclature—Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange
Language:	English
File Format:	PDF
Word Count:	12000 words
Price(USD):	360 (USD)
Delivery:	via email in 1-3 business day

前言 Ⅲ
引言 Ⅳ
1 范围 1
2 规范性引用文件 1
3 术语和定义 1
4 结构原则 4
4.1 总则 4
4.2 器械类目 4
4.3 集合术语 4
4.4 同类器械 4
4.5 器械类型 5
4.6 术语系统结构示例 5
5 要求 6
5.1 器械类目 6
5.2 同类器械 6
5.3 器械类型 8
5.4 集合术语 8
6 数据文件字典 8
6.1 总则 8
6.2 器械类目数据文件 8
6.3 同类器械数据文件 8
6.4 器械类型数据文件 9
6.5 集合术语数据文件 10
附录A (资料性附录) 器械类目 11
附录B(资料性附录) 同类器械术语和同义词生成示例 13
附录C (资料性附录) 同类器械记录示例 15
附录D (资料性附录) 集合术语示例 16
参考文献 17