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YY/T 1529-2017

Chinese Standard: 'YY/T 1529-2017'
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BASIC DATA
Standard ID YY/T 1529-2017 (YY/T1529-2017)
Description (Translated English) ELISA analytical instruments
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C44
Classification of International Standard 11.100
Word Count Estimation 10,143
Date of Issue 2017-05-02
Date of Implementation 2018-04-01
Drafting Organization Beijing Medical Device Inspection Institute, Shanghai Branch of China Experimental System Co., Ltd., Jiangsu Sino-British Novartis Medical Technology Co., Ltd., Shenzhen Aikang Biological Technology Co., Ltd., Yantai Orth State Biological Engineering Co., Ltd.
Administrative Organization National Medical Clinical Laboratory and in vitro diagnostic system standardization Technical Committee (SAC/TC 136)
Regulation (derived from) China Food & Drug Administration Announcement 2017 No. 49
Proposing organization China Food and Drug Administration
Issuing agency(ies) State Food and Drug Administration

YY/T 1529-2017
YY
PHARMACUETICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.100
C 44
ELISA Analytical Instruments
酶联免疫分析仪
ISSUED ON. MAY 2, 2017
IMPLEMENTED ON. APRIL 1, 2018
Issued by. China Food and Drug Administration
Table of Contents
Foreword ... 3 
1 Application Scope ... 4 
2 Normative References ... 4 
3 Terms and Definitions ... 5 
4 Classification ... 5 
5 Requirements ... 6 
6 Experimental Method ... 7 
7 Marking, Labelling and Operating Manual ... 12 
8 Packaging, Storage and Transportation ... 12 
Annex A (Informative) Preparation Method of Sensitivity Solution Standard
Substance for the ELISA Analytical Instruments ... 13 
Bibliography ... 14 
Foreword
This Standard was drafted in accordance with the rules given in GB/T 1.1-2009.
Attention is drawn to the possibility that some of the elements of this document may
be the subject of patent rights. The issuer of this document shall not be held
responsible for identifying any or all such patent rights.
This Standard was proposed by China Food and Drug Administration.
This Standard shall be under the jurisdiction of National Technical Committee on
Medical Clinical Laboratory and In Vitro Diagnosis Systems of Standardization
Administration of China (SAC/TC 136).
The drafting organizations of this Standard. Beijing Testing Institute of Medical Devices,
Shanghai Kehua Experimental System Co., Ltd., Jiangsu Sinnowa Medical Technology
Co., Ltd., Shenzhen Aikang Medtech Co., Ltd., Yantai Ausbio Bioengineering Co., Ltd.
The main drafters of this Standard. Wang Ruixia, Li Dong, Zhou Qiang, Zhang
Chuanguo, Liu Yanchun, Zhuang Chuansong.
ELISA Analytical Instruments
1 Application Scope
This Standard defines the terms and definitions of ELISA analytical instruments
(hereinafter referred to as the analytical instruments), and specifies the classification,
requirements, test method, marking, labelling, operating manual, packaging, storage
and transportation.
This Standard applies to the reading modules of ELISA analytical instruments and full-
automatic ELISA analytical instruments.
2 Normative References
The following referenced documents are indispensable for the application of this
document. For dated references, only the edition dated applies to this document. For
undated references, the latest edition of the referenced documents (including all
amendments) applies to This Standard.
GB/T 191, Packaging - Pictorial Marking for Handling of Goods
GB 4793.1, Safety Requirements for Electrical Equipment for Measurement,
Control and Laboratory Use - Part 1. General Requirements
GB/T 14710, Environmental Requirement and Test Methods for Medical Electrical
Equipment
GB/T 18268.1, Electrical Equipment for Measurement, Control and Laboratory Use
- EMC Requirements - Part 1. General Requirements
GB/T 18268.26, Electrical Equipment for Measurement, Control and Laboratory
Use - EMC Requirements - Part 26. Particular Requirements - In Vitro Diagnostic
(IVD) Medical Equipment
GB/T 29791.3, In Vitro Diagnostic Medical Devices - Information Supplied by the
Manufacturer (Labelling) - Part 3. In Vitro Diagnostic Instruments for Professional
Use
JJG 861-2007, Verification Regulation of ELISA Analytical Instruments
YY 0648, Safety Requirements for Electrical Equipment for Measurement Control
and Laboratory Use
The stability of absorbance of the instruments shall not exceed ± 0.005.
5.2.6 Sensitivity
Use the sensitivity concentration standard substance of concentration 5 mg/l for the
ELISA analytical instruments; and the measured absorbance value of the instruments
shall be not less than 0.01.
5.2.7 Difference of channels
Using the air as the reference, measure the absorbance difference between 8 channels;
and the required result shall not be greater than 0.02.
5.3 Electrical safety requirements
As specified in the applicable clauses of GB 4793.1 and YY 0648.
5.4 Environmental test requirements
As specified in the applicable clauses of GB/T 14710.
5.5 EMC requirements
As specified in the applicable clauses of GB/T 18268.1 and GB/T 18268.26.
5.6 Software functions
The ELISA analytical instruments shall, at least, have the following functions.
a) having the data display function;
b) being capable of setting up test items, test methods and test dates flexibly;
c) being capable of continuously storing the test items and results in succession;
d) being capable of displaying and printing the test items, test data and test time.
6 Experimental Method
6.1 Operating conditions
6.1.1 Power supply requirements. voltage 220 V ± 22 V (a.c.); frequency 50 Hz ± 1
Hz.
6.1.2 Environmental temperature. + 10°C ~ +40°C.
6.1.3 Relative humidity. 30% ~ 80%.
6.1.4 The following items shall be carried out after the instrument is started and
stabilized for 30 min. When the following experiments are carried out on the instrument,
Annex A
(Informative)
Preparation Method of Sensitivity Solution Standard Substance for the
ELISA Analytical Instruments
For the sensitivity solution standard substance for the ELISA analytical instruments,
use pure substance of potassium dichromate and sulfuric acid 0.05 mol/l as the matrix
to prepare the solution standard substance 5 mg/l.
A.1 Preparation of sulfuric acid solution 0.05 mol/l
Add 400 ml of distilled water into a 500 ml beaker; use a pipette to absorb 2.7 ml of
concentrated sulfuric acid into the beaker; stir up before pouring into a 1 000 ml
volumetric flask; add distilled water to dilute to the scale line; and shake up as standby.
A.2 Preparation of potassium dichromate solution standard substance of
chromium content 5 mg/l
A.2.1 Step 1
Weigh accurately 0.282 9 g of potassium dichromate on the analytical balance to place ......
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