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Chinese Standard: YY/T 1630-2018

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Fundamental requirements for unique device identifier


Standard in brief
Scope of Application:  
本标准规定了医疗器械唯一标识的相关术语和定义、基本原则、产品标识的要求和生产标识的要求。
本标准适用于医疗器械唯一标识的管理。

Basic information
Standard No:YY/T 1630-2018
Standard Name:医疗器械唯一标识基本要求
English Name:Fundamental requirements for unique device identifier
Standard Status:现行
Release Date:2018-12-20
Effective Date:2020-01-01
Language of Publication:中文简体

Standard Classification
ICS Number:11.040.01;35.040
CCS Number:C30

Related Standards
Referenced Standards:GB/T 1988,YY/T 0287

Publication Information
Number of pages:12
Number of words:12 K
Format:大16
Edition:1
Color Pages:0
Electronic Version:Yes
Color Images:No
Print Publication Date:2019-01-01

Standard Revision Information
Has Amendment:No

Other Information
Application Dept:国家药品监督管理局
Standard Type:QT
Standard Attribute:YY
Other Standard Number:1630
Drafter:易力、余新华、何昆仑、母瑞红、郑佳、许慧雯、王剑
Drafting Organization:原国家食品药品监督管理总局医疗器械标准管理中心、中国人民解放军总医院
Management Organization:原国家食品药品监督管理总局医疗器械标准管理中心
Proposing Department:国家药品监督管理局

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