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YY/T 1155-2009 English PDF (YYT1155-2009)

YY/T 1155-2009 English PDF (YYT1155-2009)

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YY/T 1155-2009: Automatic Luminescence Immunoassay Analyzer

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. 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.
YY/T 1155-2009
YY
ICS 11.100
C 44
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
Automatic Luminescence Immunoassay
Analyzer
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 and 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;
c) The accompanying documents shall include the product specifications and packing list;
d) The outer of packing box shall mark the marks specified by GB/T 191. 7.2 Transportation
Transportation shall be in accordance with the requirements specified in the Order Contract.
7.3 Storage
Packaged analyzer shall be stored at the environment at -40°C-55°C, relative humidity not more than 70%, without corrosive gases, and with ventilated conditions (when storage conditions are not consistent with manufacturing enterprise’s nominal values, product’s nominal values shall prevail. Manufacturing enterprise shall specify in the product standard).

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