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Chinese Standard: YY/T 1838-2022

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Disposable capillary blood collection device


Standard in brief
Scope of Application:  
本文件规定了一次性使用末梢采血器(以下简称采血器)的产品分类、要求、试验方法、标志、包装、运输、贮存。
本文件适用于穿刺皮肤以采集人体末梢血样的采血器。

Basic information
Standard No:YY/T 1838-2022
Standard Name:一次性使用末梢采血器
English Name:Disposable capillary blood collection device
Standard Status:现行
Release Date:2022-05-18
Effective Date:2023-06-01
Language of Publication:中文简体

Standard Classification
ICS Number:11.040.10
CCS Number:C30

Related Standards
Referenced Standards:GB/T 14233.1-2008,GB/T 16886.1,GB/T 18457-2015,YY 0174-2019,YY/T 0466.1

Publication Information
Number of pages:12
Number of words:23 K
Format:大16
Edition:1
Color Pages:0
Electronic Version:Yes
Color Images:No
Print Publication Date:2022-06-01

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:1838
Drafter:张立波、孙建军、施国平、周庭丽、董美成、贾彧飞、孙娟娟、王颖、陈勇、韩乃水
Drafting Organization:天津华鸿科技股份有限公司、山东省医疗器械产品质量检验中心、苏州施莱医疗器械有限公司、碧迪医疗器械(上海)有限公司、天津市医疗器械审评查验中心
Management Organization:全国医用输液器具标准化技术委员会(SAC/TC 106)
Proposing Department:国家药品监督管理局

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