YY/T 0655-2024 Active Industry standards-Medicine

YY/T 0655-2024 Dry chemistry analyzer

Publish Date: 2024-02-07 Implement Date: 2025-03-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 0655-2024

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical laboratory equipment

ICS Name: -

Publish Date: 2024-02-07

Implement Date: 2025-03-01

Publisher: 国家药品监督管理局

Technical Committee: 全国医用临床检验实验室和体外诊断系统标准化技术委员会(SAC/TC 136)

Pages: 12 pages

Scope

本文件规定了干式化学分析仪(以下简称分析仪)的要求、标志、标签、使用说明书和包装、运输、贮存，描述了相应的试验方法。本文件适用于配套使用固相载体试剂，在医学临床上对患者的血液、尿液和脑脊液等样品进行化学检验的分析仪。本文件不适用于血糖分析仪、尿液分析仪、血气分析仪或其他干式分析仪。

Development Information

Drafting Units:

北京市医疗器械检验研究院(北京市医用生物防护装备检验研究中心)、江苏省计量科学研究院(江苏省能源计量数据中心)、奥森多医疗器械贸易(中国)有限公司、富士胶片(中国)投资有限公司

Drafting Persons:

赵丙锋、崔宏恩、苏捷、沈海涛、李胜民

Word Count: 13 Thousand words Pages: 12 pages

Replace the following standards

YY/T 0655-2008 Dry chemistry analyzer

Referenced Standards

GB/T 191-2000 Packaging—Pictorial marking for handling of goods GB/T 191-2008 Packaging—Pictorial marking for handling of goods GB 4793.1-1995 Safety requirements for electrical equipment for measurement, control, and laboratory use Part 1:General requirements GB 4793.1-2007 Safety requirements for electrical equipment for measurement, control, and laboratory use—Part 1:General requirements GB 4793.6-2001 Safety requirements for electrical equipment for measurement, control and laboratory use—Particular requirements for laboratory equipment for the heating of materials GB 4793.6-2008 Safety requirements for electrical equipment for measurement,control,and laboratory use—Part 6:Particular requirements for laboratory equipment for the heating of materials GB/T 14710-1993 The environmental requirements and test methods for medical electrical equipment GB/T 14710-2009 Environmental requirement and test methods for medical electrical equipment GB/T 18268.1-2010 Electrical equipment for measurement,control and laboratory use—EMC requirements—Part 1:General requirements GB/T 18268.26-2010 Electrical equipment for measurement,control and laboratory use—EMC requirements—Part 26:Particular requirements—In vitro diagnostic (IVD) medical equipment GB/T 29791.3-2013 In vitro diagnostic medical devices—Information supplied by the manufacturer(labelling)—Part 3:In vitro diagnostic instruments for professional use YY 0648-2008 Safety requirements for electrical equipment for measurement,control and laboratory use—Part 2-101:Particular requirements for in vitro diagnostic (IVD) medical equipment GB/T 18268.1-2025 Electrical equipment for measurement,control and laboratory use—EMC requirements—Part 1:General requirements GB/T 191-2025 Graphical symbols marking for handling and storage of packages YY/T 0648-2025 Safety requirements for electrical equipment for measurement,control,and laboratory use—Part 2-101:Particular requirements for in vitro diagnostic (IVD)medical equipment

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