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YY/T 1529-2017 English PDF (YYT1529-2017)

YY/T 1529-2017 English PDF (YYT1529-2017)

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YY/T 1529-2017: ELISA analytical instruments

This Standard defines the terms and definitions of ELISA analytical instruments; specifies the classification, requirements, test methods, marks, labels and instruction manual, package, storage and transportation. This Standard is applicable to the ELISA analytical instrument, automatic ELISA analytical instrument reading module.
YY/T 1529-2017
YY
PHARMACUETICAL INDUSTRY STANDARD
OF THE PEOPLE REPUBLIC OF CHINA
ICS 11.100
C 44
ELISA Analytical Instruments
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 into a 100 ml beaker; use sulfuric acid solution 0.05 mol/l to dissolve before transferring to a 500 ml volumetric flask; use a small amount of sulfuric acid solution 0.05 mol/l to wash the beaker for several times; pour the washings into the volumetric flask; use sulfuric acid solution 0.05 mol/l to dilute to the scale line; and shake up as standby. The concentration of the solution is 200 mg/l.
A.2.2 Step 2
Use a pipette to transfer 2.5 ml of potassium dichromate solution 200 mg/l into a 100 ml volumetric flask; use sulfuric acid solution 0.05 mol/l to dilute to the scale line; and shake up. Then, the concentration of the solution is 5 mg/l.

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