9秒发货/有发票 梧三标准英文版 优质技术翻译  数据库收录:159759 最近更新:2020-05-14  
支付宝/对公账号 首页   询价  购买流程  英文样品 公司简介   购物车

YY/T 1155-2019

标准搜索结果: 'YY/T 1155-2019'
标准号码内文价格(元)第2步交付天数标准名称状态
YY/T 1155-2019 英文版 2099 购买 有增值税发票,[PDF]天数 <=3 全自动发光免疫分析仪 有效

   
标准编号: YY/T 1155-2019 (YY/T1155-2019)
中文名称: 全自动发光免疫分析仪
英文名称: Automatic luminescence immunoassay analyzer
行业: 医药行业标准 (推荐)
中标分类: C44
国际标准分类: 11.100
字数估计: 14,147
发布日期: 2019-05-31
实施日期: 2020-06-01
起草单位: 北京市医疗器械检验所、深圳迈瑞生物医疗电子股份有限公司、深圳市新产业生物医学工程股份有限公司、安图实验仪器(郑州)有限公司、北京科美生物技术有限公司、长春迪瑞医疗科技股份有限公司、厦门万泰凯瑞生物技术有限公司、罗氏诊断产品(上海)有限公司、雅培贸易(上海)有限公司、贝克曼库尔特商贸(中国)有限公司
归口单位: 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)
提出机构: 国家药品监督管理局
发布机构: 国家药品监督管理局

YY/T 1155-2019
Automatic luminescence immunoassay analyzer
ICS 11.100
C44
中华人民共和国医药行业标准
代替YY/T 1155-2009
全自动发光免疫分析仪
2019-05-31发布
2020-06-01实施
国家药品监督管理局 发 布
前言
本标准按照GB/T 1.1-2009给出的规则起草。
请注意本文件的某些内容可能涉及专利。本文件的发布机构不承担识别这些专利的责任。
本标准代替YY/T 1155-2009《全自动发光免疫分析仪》,与YY/T 1155-2009相比,除编辑性修
改外主要技术变化如下:
---增加了“本标准不适用于基于图像识别的发光免疫分析仪”(见第1章);
---增加了电磁兼容性标准、体外诊断设备安全专用标准、体外诊断设备标示标准,具体调整如下:
● 增加引用了GB 4793.6、GB 4793.9和YY0648(见5.10);
● 增加引用了GB/T 18268.1和GB/T 18268.26(见5.11);
● 增加引用了GB/T 29791.3(见6);
● 删除了YY0466(见2009年版的6)。
---在规范性引用文件清单中,删除了所列标准的年号(见第2章);
---增加了加样正确度与重复性的要求和相应的试验方法(见4.1和5.2);
---修改了反应区温度控制的正确度和波动度的要求和相应试验方法(见4.2和5.3,2009年版的
4.1和5.3);
---增加了光检测装置部分的要求和相应的试验方法(见4.3和5.4);
---删除了分析仪稳定性,增加了发光值的稳定性(见4.3.4和5.4.4,2009年版的4.2和5.4);
---删除了线性相关性,增加了发光值的线性(见4.3.2和5.4.2,2009年版的4.4和5.6);
---增加了对仅能报告定性检验结果的分析仪的携带污染的要求(见4.4);
---修改了临床项目的批内精密度的要求和相应的试验方法(见4.5和5.6);
---增加了GB 4793.6、GB 4793.9、YY0648安全要求和试验方法(见4.9和5.10);
---增加了GB/T 18268.1、GB/T 18268.26电磁兼容要求和试验方法(见4.10和5.11);
---标签、标记和使用说明书改为应符合GB/T 29791.3的要求(见6);
---增加了附录A纯水密度表(见附录A)。
本标准由国家药品监督管理局提出。
本标准由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/TC136)归口。
本标准起草单位:北京市医疗器械检验所、深圳迈瑞生物医疗电子股份有限公司、深圳市新产业生
物医学工程股份有限公司、安图实验仪器(郑州)有限公司、北京科美生物技术有限公司、长春迪瑞医疗
科技股份有限公司、厦门万泰凯瑞生物技术有限公司、罗氏诊断产品(上海)有限公司、雅培贸易(上海)
有限公司、贝克曼库尔特商贸(中国)有限公司。
本标准主要起草人:王军、王俊、尹力、王超、王建梅、常淑芹、孙旭东、蔡晓蓉、王雪峰、臧玉兰。
本标准所代替标准的历次版本发布情况为:
---YY/T 1155-2009。
全自动发光免疫分析仪
1 范围
本标准规定了全自动发光免疫分析仪的要求、试验方法、标签、标记和使用说明书、包装、运输和
贮存。
本标准适用于医学实验室使用的全自动发光免疫分析仪(以下简称分析仪)。分析仪采用发光系统
和免疫分析方法对人类血清、血浆或其他体液中的各种被分析物进行定量或定性检测,包括基于化学发
光、电化学发光、荧光等原理的发光免疫分析仪。
本标准不适用于:基于图像识别的发光免疫分析仪;即时检验(POCT)的全自动发光免疫分析仪。
2 规范性引用文件
下列文件对于本文件的应用是必不可少的。凡是注日期的引用文件,仅注日期的版本适用于本文
件。凡是不注日期的引用文件,其最新版本(包括所有的修改单)适用于本文件。
GB/T 191 包装储运图示标志
GB 4793.1 测量、控制和实验室用电气设备的安全要求 第1部分:通用要求
GB 4793.6 测量、控制和实验室用电气设备的安全要求 第6部分:实验室用材料加热设备的特
殊要求
GB 4793.9 测量、控制和实验室用电气设备的安全要求 第9部分:实验室用分析和其他目的自
动和半自动设备的特殊要求
GB/T 14710 医用电器环境要求及试验方法
GB/T 18268.1 测量、控制和实验室用的电设备 电磁兼容性要求 第1部分:通用要求
GB/T 18268.26 测量、控制和实验室用的电设备 电磁兼容性要求 第26部分:特殊要求 体
外诊断(IVD)医疗设备
GB/T 29791.3 体外诊断医疗器械 制造商提供的信息(标示) 第3部分:专业用体外诊断仪器
YY0648 测量、控制和实验室用电气设备的安全要求 第2-101部分:体外诊断(IVD)医用设备
的专用要求
3 术语和定义
下列术语和定义适用于本文件。
3.1
发光免疫分析 luminescenceimmunoassay
将发光系统与免疫反应相结合,以检测抗原或抗体的方法。
3.2
发光免疫分析仪 luminescenceimmunoassayanalyzer
以发光免疫分析技术为基本原理的免疫分析仪,可进行定性或定量检测。
3.3
所有分析过程包括样品和试剂的加注、免疫结合反应环境的提供、数据测量、结果计算和输出都实

YY/T 1155-2019
Automatic luminescence immunoassay analyzer
ICS 11.100
C44
People's Republic of China Pharmaceutical Industry Standard
Replacing YY/T 1155-2009
Fully automatic illuminating immunoassay analyzer
Published on.2019-05-31
2020-06-01 implementation
State Drug Administration issued
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that some of the contents of this document may involve patents. The issuing organization of this document is not responsible for identifying these patents.
This standard replaces YY/T 1155-2009 "Full-automatic Luminous Immunoassay Analyzer", compared with YY/T 1155-2009, except for editorial repair
The main technical changes changed are as follows.
--- Added "This standard does not apply to illuminating immunoassays based on image recognition" (see Chapter 1);
--- Added electromagnetic compatibility standards, special standards for in vitro diagnostic equipment safety, and in vitro diagnostic equipment labeling standards. The specific adjustments are as follows.
● Added references to GB 4793.6, GB 4793.9 and YY 0648 (see 5.10);
● Added references to GB/T 18268.1 and GB/T 18268.26 (see 5.11);
● Added reference to GB/T 29791.3 (see 6);
● YY 0466 has been deleted (see 6 of the.2009 edition).
--- In the list of normative references, the year number of the listed standard is deleted (see Chapter 2);
--- Increased the accuracy and repeatability of the sample and the corresponding test methods (see 4.1 and 5.2);
--- Revised the requirements for the correctness and volatility of the temperature control of the reaction zone and the corresponding test methods (see 4.2 and 5.3,.2009 edition)
4.1 and 5.3);
--- Increased the requirements of the light detection device section and the corresponding test methods (see 4.3 and 5.4);
--- Removed analyzer stability and increased luminescence stability (see 4.3.4 and 5.4.4,.2009 editions 4.2 and 5.4);
--- Removed linear correlation and increased linearity of luminescence values (see 4.3.2 and 5.4.2, 4.4 and 5.6 for.2009);
--- Increased the requirements for carrying contamination of analyzers that can only report qualitative test results (see 4.4);
--- Revised the intra-assay precision requirements of the clinical project and the corresponding test methods (see 4.5 and 5.6);
--- Added GB 4793.6, GB 4793.9, YY 0648 safety requirements and test methods (see 4.9 and 5.10);
--- Added GB/T 18268.1, GB/T 18268.26 electromagnetic compatibility requirements and test methods (see 4.10 and 5.11);
--- Labels, markings and instructions for use should be in accordance with the requirements of GB/T 29791.3 (see 6);
--- Added Appendix A Pure Water Density Table (see Appendix A).
This standard was proposed by the State Drug Administration.
This standard is under the jurisdiction of the National Medical Clinical Laboratory and the In vitro Diagnostic System Standardization Technical Committee (SAC/TC136).
This standard was drafted. Beijing Medical Device Inspection Institute, Shenzhen Mindray Biomedical Electronics Co., Ltd., Shenzhen New Industrial Students
Medical Engineering Co., Ltd., Antu Experimental Instrument (Zhengzhou) Co., Ltd., Beijing Kemei Biotechnology Co., Ltd., Changchun Dirui Medical
Technology Co., Ltd., Xiamen Wantai Kerry Biotechnology Co., Ltd., Roche Diagnostics (Shanghai) Co., Ltd., Abbott Trade (Shanghai)
Ltd., Beckman Coulter Trading (China) Co., Ltd.
The main drafters of this standard. Wang Jun, Wang Jun, Yin Li, Wang Chao, Wang Jianmei, Chang Shuqin, Sun Xudong, Cai Xiaorong, Wang Xuefeng, Yan Yulan.
The previous versions of the standards replaced by this standard are.
---YY/T 1155-2009.
Fully automatic illuminating immunoassay analyzer
1 Scope
This standard specifies the requirements, test methods, labels, markings and instructions for use, packaging, transportation and
Storage.
This standard applies to the fully automatic illuminating immunoassay analyzer (hereinafter referred to as the analyzer) used in medical laboratories. Analyzer using illumination system
And immunoassay methods for quantitative or qualitative detection of various analytes in human serum, plasma or other body fluids, including chemical-based
A light-emitting immunoassay analyzer based on the principles of light, electrochemiluminescence, and fluorescence.
This standard does not apply to. light-emitting immunoassay analyzer based on image recognition; full-automatic illumination immunoassay analyzer for immediate inspection (POCT).
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article.
Pieces. For undated references, the latest edition (including all amendments) applies to this document.
GB/T 191 packaging storage and transportation icon
Safety of electrical equipment for measurement, control and laboratory use - Part 1. General requirements
GB 4793.6 Safety requirements for electrical equipment for measurement, control and laboratory use - Part 6
Special requirements
GB 4793.9 Safety requirements for electrical equipment for measurement, control and laboratory use - Part 9. Laboratory analysis and other purposes
Special requirements for moving and semi-automatic equipment
GB/T 14710 Medical electrical requirements and test methods
GB/T 18268.1 Electromagnetic compatibility requirements for electrical equipment - Part 1 . General requirements
GB/T 18268.26 Electromagnetic compatibility requirements for electrical equipment for measurement, control and laboratory - Part 26. Particular requirements
External diagnostic (IVD) medical equipment
GB/T 29791.3 Information provided by in vitro diagnostic medical device manufacturers (labeling) Part 3. Professional in vitro diagnostic equipment
Safety of electrical equipment for measurement, control and laboratory use - Part 2-101. In vitro diagnostic (IVD) medical equipment
Special requirements
3 Terms and definitions
The following terms and definitions apply to this document.
3.1
A method of combining an illuminating system with an immune response to detect an antigen or antibody.
3.2
Luminescence immunoassay analyzer luminescenceimmunoassayanalyzer
An immunoassay analyzer based on luminescent immunoassay technology can perform qualitative or quantitative detection.
3.3
All analytical procedures include the addition of samples and reagents, the provision of immunological binding reactions, data measurements, calculation of results, and output.
YY/T 1155-2019
Automatic luminescence immunoassay analyzer
ICS 11.100
People's Republic of China Pharmaceutical Industry Standard
Replacing YY/T 1155-2009
Fully automatic illuminating immunoassay analyzer
Published on.2019-05-31
2020-06-01 implementation
State Drug Administration issued
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that some of the contents of this document may involve patents. The issuing organization of this document is not responsible for identifying these patents.
The main technical changes changed are as follows.
--- Added "This standard does not apply to illuminating immunoassays based on image recognition" (see Chapter 1);
--- Added electromagnetic compatibility standards, special standards for in vitro diagnostic equipment safety, and in vitro diagnostic equipment labeling standards. The specific adjustments are as follows.
● Added references to GB 4793.6, GB 4793.9 and YY 0648 (see 5.10);
● Added references to GB/T 18268.1 and GB/T 18268.26 (see 5.11);
● Added reference to GB/T 29791.3 (see 6);
● YY 0466 has been deleted (see 6 of the.2009 edition).
--- In the list of normative references, the year number of the listed standard is deleted (see Chapter 2);
--- Increased the accuracy and repeatability of the sample and the corresponding test methods (see 4.1 and 5.2);
4.1 and 5.3);
--- Increased the requirements of the light detection device section and the corresponding test methods (see 4.3 and 5.4);
--- Removed analyzer stability and increased luminescence stability (see 4.3.4 and 5.4.4,.2009 editions 4.2 and 5.4);
--- Removed linear correlation and increased linearity of luminescence values (see 4.3.2 and 5.4.2, 4.4 and 5.6 for.2009);
--- Increased the requirements for carrying contamination of analyzers that can only report qualitative test results (see 4.4);
--- Revised the intra-assay precision requirements of the clinical project and the corresponding test methods (see 4.5 and 5.6);
--- Added GB 4793.6, GB 4793.9, YY 0648 safety requirements and test methods (see 4.9 and 5.10);
--- Added GB/T 18268.1, GB/T 18268.26 electromagnetic compatibility requirements and test methods (see 4.10 and 5.11);
--- Labels, markings and instructions for use should be in accordance with the requirements of GB/T 29791.3 (see 6);
This standard was proposed by the State Drug Administration.
This standard is under the jurisdiction of the National Medical Clinical Laboratory and the In vitro Diagnostic System Standardization Technical Committee (SAC/TC136).
This standard was drafted. Beijing Medical Device Inspection Institute, Shenzhen Mindray Biomedical Electronics Co., Ltd., Shenzhen New Industrial Students
Medical Engineering Co., Ltd., Antu Experimental Instrument (Zhengzhou) Co., Ltd., Beijing Kemei Biotechnology Co., Ltd., Changchun Dirui Medical
Technology Co., Ltd., Xiamen Wantai Kerry Biotechnology Co., Ltd., Roche Diagnostics (Shanghai) Co., Ltd., Abbott Trade (Shanghai)
Ltd., Beckman Coulter Trading (China) Co., Ltd.
The main drafters of this standard. Wang Jun, Wang Jun, Yin Li, Wang Chao, Wang Jianmei, Chang Shuqin, Sun Xudong, Cai Xiaorong, Wang Xuefeng, Yan Yulan.
The previous versions of the standards replaced by this standard are.
---YY/T 1155-2009.
1 Scope
This standard specifies the requirements, test methods, labels, markings and instructions for use, packaging, transportation and
Storage.
This standard applies to the fully automatic illuminating immunoassay analyzer (hereinafter referred to as the analyzer) used in medical laboratories. Analyzer using illumination system
And immunoassay methods for quantitative or qualitative detection of various analytes in human serum, plasma or other body fluids, including chemical-based
A light-emitting immunoassay analyzer based on the principles of light, electrochemiluminescence, and fluorescence.
This standard does not apply to. light-emitting immunoassay analyzer based on image recognition; full-automatic illumination immunoassay analyzer for immediate inspection (POCT).
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article.
GB/T 191 packaging storage and transportation icon
Safety of electrical equipment for measurement, control and laboratory use - Part 1. General requirements
GB 4793.6 Safety requirements for electrical equipment for measurement, control and laboratory use - Part 6
Special requirements
GB 4793.9 Safety requirements for electrical equipment for measurement, control and laboratory use - Part 9. Laboratory analysis and other purposes
Special requirements for moving and semi-automatic equipment
GB/T 14710 Medical electrical requirements and test methods
GB/T 18268.1 Electromagnetic compatibility requirements for electrical equipment - Part 1 . General requirements
GB/T 18268.26 Electromagnetic compatibility requirements for electrical equipment for measurement, control and laboratory - Part 26. Particular requirements
GB/T 29791.3 Information provided by in vitro diagnostic medical device manufacturers (labeling) Part 3. Professional in vitro diagnostic equipment
Safety of electrical equipment for measurement, control and laboratory use - Part 2-101. In vitro diagnostic (IVD) medical equipment
Special requirements
3 Terms and definitions
The following terms and definitions apply to this document.
3.1
Luminescence immunoassay luminescenceimmunoassay
A method of combining an illuminating system with an immune response to detect an antigen or antibody.
3.2
An immunoassay analyzer based on luminescent immunoassay technology can perform qualitative or quantitative detection.
3.3
All analytical procedures include the addition of samples and reagents, the provision of immunological binding reactions, data measurements, calculation of results, and output.
   
宁德梧三商贸有限公司 | 纳税人识别号:91350900MA32WE2Q2X | 营业执照:营业执照证书
点击联络我们 联系电邮郑文锐销售经理: Sales@gb-gbt.cn | Sales@ChineseStandard.net | 电话郑经理: 18059327808 | 增值税普通发票 / 增值税专用发票样品
对公开户银行:中国建设银行古田支行 | 账号:35050168730700000955 | 账户名称:宁德梧三商贸有限公司 | 大额行号(非必须):105403500207 对公银行账号证书
翻译支持:全资母公司新加坡场测亚洲公司(https://www.ChineseStandard.net 卖欧美后再内销)
网站备案许可:闽ICP备19012676号 http://www.beian.miit.gov.cn
隐私   ·  优质产品   ·  退款政策   ·  公平交易   ·  关于我们