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YY/T 1155-2009

Chinese Standard: 'YY/T 1155-2009'
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Detail Information of YY/T 1155-2009; YY/T1155-2009
Description (Translated English): Automatic Luminescence Immunoassay Analyzer
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C44
Classification of International Standard: 11.100
Word Count Estimation: 8,895
Date of Issue: 2009-12-30
Date of Implementation: 2011-06-01
Quoted Standard: GB/T 191; GB/T 14710; GB 4793.1-2007; YY 0466-2003
Drafting Organization: Beijing Medical Device Testing
Administrative Organization: National Standardization Technical Committee of Medical clinical testing laboratories and in vitro diagnostic systems
Regulation (derived from): China Food & Drug Administration Announcement 2009 No.83
Summary: This standard specifies the fully automated immunoassay analyzer requirements, test methods, marking, labeling and brochures, packaging, transport and storage of materials. This standard applies to automated immunoassay analyzer (hereinafter referred to as the analyzer). Analyzer using luminescence immunoassay systems and methods of human serum, plasma or other body fluids of various analytes quantitative and qualitative detection, including those based on chemiluminescence, electrochemiluminescence, such as the principle of fluorescence immunoassay analyzer.

YY/T 1155-2009
YY
ICS 11.100
C 44
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
Automatic Luminescence Immunoassay
Analyzer
全自动发光免疫分析仪
ISSUED ON. DECEMBER 30, 2009
IMPLEMENTED ON. JUNE 1, 2011
Issued by. State Food and Drug Administration
Table of Contents
Foreword ... 3 
1  Scope ... 4 
2  Normative references ... 4 
3  Terms and definitions ... 4 
4  Requirements ... 5 
5  Test methods ... 6 
6  Marks, labels and instructions ... 10 
7  Packaging, transportation and storage ... 11 
Foreword 
The Standard was proposed by China Food and Drug Administration.
The Standard shall be under the jurisdiction of National Technical Committee (SAC/TC
136) on System of Medical Clinical Test Lab and in Vitro Diagnostic System of
Standardization Administration of China.
Drafting organization of this Standard. Beijing Institute of Medical Device Testing, Abbott
Laboratories Ltd, Johnson & Johnson Medical (China) Ltd, Roche Diagnostics (Shanghai)
Limited, and Beckman Coulter Commercial Enterprise (China) Co., Ltd.
The main drafters of this Standard. Wang Jun, Wang Xuefeng, Zhang Zhang, Cai
Xiaorong, Zhang Jinwen, and Zhang Xinmei.
Automatic Luminescence Immunoassay Analyzer
1  Scope 
This Standard specifies the requirements, test methods, marks, labels and instructions,
packaging, transportation, and storage of automatic luminescence immunoassay
analyzer.
This Standard applies to automatic luminescence immunoassay analyzer (hereinafter
referred to as “the Analyzer”). The Analyzer uses luminescent system and immunological
analyzing method to set and qualitatively detect human blood serum, plasma or other
body fluids in a variety of analytes, including luminescent immunoassay analyzers based
on principle of chemiluminescence, electrochemical luminescence, fluorescence, etc.
2  Normative references 
The articles contained in the following documents have become part of this Standard
when they are quoted herein. For the dated documents so quoted, all the modifications
(excluding corrections) or revisions made thereafter shall not be applicable to this
Standard. For the undated documents so quoted, the latest editions shall be applicable to
this Standard.
GB/T 191 Packaging - Pictorial marking for handling of goods
GB/T 14710 Environmental requirement and test methods for medical electrical
equipment
GB 4793.1-2007 Safety requirements for electrical equipment for measurement,
control, and laboratory use - Part 1. General requirements (IEC 61010-1. 2001, IDT)
YY 0466-2003 Medical devices - Symbols to be used with medical device labels
labelling and information to be supplied (ISO 15223. 2000, IDT)
3  Terms and definitions 
For the purpose of this Standard, the following terms and definitions apply.
3.1
Luminescence immunoassay
It refers to the method to detect antigen or antibody, by combining luminescent system
The Analyzer shall be equipped with the following main functions.
a) Through the man-machine interactive instructions, users can make the instrument to
automatically complete the analytical tasks of different samples and test items;
b) The instrument shall be able to present the state of consumables and wastes such
as reagents;
c) The instrument is equipped with a self-checking function;
d) Fault prompt. The instrument shall have corresponding prompts for the operation
mistake, mechanical and electrical faults.
4.7 Appearance
The appearance shall meet the following requirements.
a) The appearance shall be clean and free of cracks or scratches, with clear words and
marks;
b) The moving parts of analysis system shall be smooth and shall not be stuck or
jumped;
c) Fasteners shall be connected firmly and reliably. It must not be loosen.
4.8 Safety requirements
It shall comply with the requirements of GB 4793.1-2007.
4.9 Requirements of environmental test
The environmental test shall meet the following requirements.
a) The climatic environment test shall comply with the provisions of Group I for climatic
environment test in GB/T 14710;
b) The mechanical environment test shall comply with the provisions of Group I for
mechanical environment test in GB/T 14710.
5  Test methods 
5.1 Normal working environment conditions
5.1.1 Power supply voltage. 220 V ± 22 V, 50 Hz ± 1 Hz;
5.1.2 Environment temperature. 10°C-30°C;
5.1.3 Relative humidity. ≤70%;
5.11 Requirements of environmental test
The test shall be conducted in accordance with the method specified in GB/T 14710.
6  Marks, labels and instructions 
The symbols used in the labels, marks and instructions of the Analyzer shall comply with
the requirements of YY 0466-2003.
6.1 Marks and labels
6.1.1 Outer marks
Outer marks, including the nameplate, of the instrument shall mark.
a) Name, model / trademark of the product;
b) Power supply conditions.
c) Ex-factory serial number and date;
d) Name of manufacturing enterprise.
6.1.2 Outer packaging
The external packaging of the instrument shall mark.
a) Name, model / trademark of the product;
b) Size and weight;
c) Ex-factory serial number or date;
d) Transportation and storage marks. Graphic marks shall comply with provisions of
GB/T 191;
e) The allowable environmental conditions for transportation and storage;
f) Name and address of manufacturing enterprise.
6.2 Instructions
The instructions, including operating instructions and technical specifications, shall
comply with relevant requirements of GB 4793.1-2007 for the instructions.
7  Packaging, transportation and storage 
7.1 Packaging
Product packaging shall comply with the following requirements.
a) Accessories and accompanying documents shall be accompanied with the product
and placed in the corresponding independent package;
b) The external packing box shall be able to ensure that products are free of
mechanical and natural damages; ......
Related standard:   YY/T 1155-2019  YY/T 1150-2009
   
 
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