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1、J I S K*070L 88 4933608 0055449 4 UDC 543.25 : 577.152.1 : 547.455.623 JIS. JAPANESE INDUSTRIAL STANDARD Glucose Analyzer JIS K 0 7 0 1 - 1 9 8 8 a Translated and Published by Japanese Standards Association Printed in Japan Copyright Japanese Standards Association Provided by IHS under license with
2、JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/12/2007 08:27:56 MDTNo reproduction or networking permitted without license from IHS -,-,- J I S K*0701 88 I I Li933608 0055Li50 O W In the event of any doubt arising, the original Standard in Japanese is to be final authorit
3、y. Copyright Japanese Standards Association Provided by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/12/2007 08:27:56 MDTNo reproduction or networking permitted without license from IHS -,-,- J I S K*070L ?#A E 4733608 0055451 2 W UDC 543.25:577.1
4、52.1:547.455.623 JAPANESE INDUSTRIAL STANDARD J I S Glucose Analyzer K 0701-1988 1 Scope This Japanese Industrial Standard applies to analyzers based on the enzyme electrode method combined with fixed glucose oxidase and oxygen electrode or hydrogen peroxide electrode out of analyzers for measuring
5、glucose concentration, hereinafter referred to as the lfanalyzerll, contained in sample solution for example, blood, urine, fermentation liquid, foods, etc. 2. Common Items The common items shall be in accordance with JIS K 0050 and JIS K 8001. 3. Definitions For the purpose of this Standard main de
6、finitions shall be in accord- ance with JIS K 0211 and JIS Z 8103 and for others following definitions apply: (1) glucose oxidase D-glucono-&-lactone by oxidizing P-body (B-D-glucose) which is one of isomers of glucose (D-glucose) under existence of accep- tor of hydrogen, Usually oxygen is used as
7、the acceptor of hydrogen and the oxygen becomes hydrogen peroxide as the result of enzyme reaction, The enzyme to catalyze the reaction to give Reference: In code number according to selection of the International Biochemistry Union it is classified into EC 1.1.3.4. (2) fixed glucose oxidase The glu
8、cose oxidase made insoluble in water under the state maintaining its catalyst activity. ( 3) oxygen electrode The electrode for electro-analysis of dissolved oxygen decided in 8.3 (i) of JIS K 0803. Applicable Standards : JIS C 1302-Insulation Resistance Testers (Battery Operated) JIS K 0050-General
9、 Rules for Chemical Analysis JIS K 0211-Technical Terms for Analytical Chemistry (General Part) JIS K 0803-Recording Dissolved Oxygen Meter JIS K 4127-Benzoic Acid JIS K 8001-General Rules of Testing Methods for Reagents JIS K 8824-Dextrose, Anhydrous JIS Z 8103-Glossary of Terms Used in Instrumenta
10、tion Copyright Japanese Standards Association Provided by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/12/2007 08:27:56 MDTNo reproduction or networking permitted without license from IHS -,-,- J I S K*OOL B A 4933608 0055452 4 2 K 0701-1988 (4) h
11、ydrogen-peroxide electrode The electrode for electro-analysis of hydrogen peroxide. (5) enzyme electrode The electrode constituted by combination of electrodes to detect fixed enzyme and the substance caused as the result of the enzyme reaction. 4, Constitution of Enzyme Electrode and Measuring Syst
12、em The constitution of enzyme electrode and measuring system shall be as follows : 4 . 1 Fixed Glucose Oxidase (1) Style to cover the electrode surface (2) Column style 4 2 Oxygen Electrode or Hydrogen Peroxide Electrode (1) Oxygen electrode of diaphragm type polarograph style (2) (3) Oxygen electro
13、de of diaphragm type galvanic cell style Hydrogen peroxide electrode of polarograph style 4.3 Measuring Method for Sample Concentration (1) Batch system (2) Flow system 4.4 Calculation System of Sample Concentration (1) System to calculate from the maximum variation amount of elec- trode current (2)
14、 System to calculate from the variation amount of electrode cur- rent after a definite time (3) System to calculate from the maximum variation speed of elec- trode current (4) System to calculate from the maximum variation acceleration of electrode current (5) System to calculate from the time integ
15、ral of variation amounts of electrode current 5. Rated Voltage and Rated Frequency The rated voltage of analyzer shall be single phase a.c. 100 V, the rated frequency, 50 Hz for exclusive use, 60 Hz for exclusive use or 50 Hz and 60 Hz common use. Copyright Japanese Standards Association Provided by
16、 IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/12/2007 08:27:56 MDTNo reproduction or networking permitted without license from IHS -,-,- J I S K*O701 88 O 4933b08 0055453 b 3 K 0701-1988 6. Performance The analyzer shall comply with the following
17、performances : Repeatability (1) , the variation factor shall be within 2 %. When tested according to the test method of 8.3 Zero Drift (2), the zero drift shall be within k 2 %. When tested according to the test method of 8.3 Response Time (3), the response time shall be within 2 min. When tested a
18、ccording to the test method of 8.3 Stability Relative to Voltage Variation the test method of 8.3 (4), the variation of indicated values shall be within 2 3 %. When tested according to Insulation Resistance of 8.3 (5), the value shall be not less than 5 MQ. When tested according to the test method W
19、ithstand Voltage 8.3 (6), abnormalities shall not be generated. When tested according to the test method of 7. Structure The structure of analyzer shall be as follows: 7.1 Structure General The structure of analyzer shall comply with following each item : (1) The shape is correct, assembly and finis
20、h of each part are good and rigid. (2) There is no fear to cause danger in normal operating condition and it actuates safely and smoothly. (3) Each part does not cause easily mechanical and electrical failures and is of such structure not to cause danger. (4) To be such structure that the actuation
21、of analyzer is not inter- fered due to water leakage, water splash, dew condensation, etc (5) To be such structure that at the time of maintenance and check, it is easy to actuate and no danger is caused. 7.2 Constitution The analyzer shall be constituted of detecting part, supply and exhaust part f
22、or buffer solution and the like, and indicating part as shown in Figure. Copyright Japanese Standards Association Provided by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/12/2007 08:27:56 MDTNo reproduction or networking permitted without license
23、from IHS -,-,- JIS K*O70L 8 = 4933bO 0055454 8 M 4 K 0701-1988 Figure. Constitution of Analyzer (An Example of Style of Which Electrode Surface Is Coated by Fixed Glucose Oxidase) Detecting part buffer solution A: enzyme electrode B: measuring cell Exhaust Tp-t 1 + : flow of sample -+ : flow of elec
24、tric signal 7.3 Detecting Part The detecting part keeps the enzyme electrode and sample containing solution at the mutually contacting state and supply the generated signal safely to indicating part and shall be constituted of enzyme electrode, measuring cell, etc. (1) Enzyme Electrode The electrode
25、 constituted of fixed glucose oxidase and oxygen electrode or hydrogen-peroxide electrode, of which fixed glucose oxidase shall be of such structure that is easily exchangeable. (2) Measuring Cell The cell to hold the enzyme electrode and the sample containing solution at the state mutually contacte
26、d, which shall be of such structure that it is able to maintain the sample containing solution at a suitable temperature and at dissolved oxygen concentration and does not cause interference to the flow of sample containing solution. 7.4 Supply Part of Buffer Solution and the Like The supply part of
27、 buffer solution and the like shall be able to feed the buffer solution and the like to the detecting part. 7.5 Exhaust Part The exhaust part shall be able to exhaust and to preserve the solution after measuring from the detecting part. 7.6 Indicating Part The indicating part shall be able to detect
28、 the output signal of enzyme electrode and to indicate or to print the glucose concentration. 7.7 Accessory Apparatuses The accessory apparatuses shall be as follows, except where these are not required. (1) Sample Supply Apparatus The sample supply apparatus is such apparatus that it feeds the solu
29、tions of several samples prelimi- narily prepared in the definite sequence to the detecting part to carry out the measurement. It is desirable that it has function to feed the glucose standard solution at times and to be able to carry out the calibration of enzyme electrode. Copyright Japanese Stand
30、ards Association Provided by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/12/2007 08:27:56 MDTNo reproduction or networking permitted without license from IHS -,-,- 8. 5 K 0701-1988 (2) Output Electric Current Recorder The output electric current
31、recorder is an apparatus to record the output electric current of enzyme electrode. (3) Indicating Part of Fixed Glucose Oxidase Exchange The indi- cating part of fixed glucose oxidase exchange shall have the function to display that when the fixed glucose oxidase is dete- riorated it is necessary t
32、o exchange it. Tests 8.1 Reagents (i) Water The water for analysis specified in JIS K 0050. (2) Glucose The dextrose (anhydrous) of guaranteed grade speci- f i e d i n J I S K 8824. (3) Benzoic Acid JIS K 4127. The benzoic acid of guaranteed grade specified in (4) Dilution Solution 1000 ml. Dissolve
33、 benzoic acid about 1 g in water (5) Glucose Standard Solution (1 w/v %) Weigh out correctly glucose 5.00 g, add glucose little by little to a transfer flask of 500 ml added with dilution solution about 300 ml while shaking to dissolve the glucose completely, thereafter keep it in a constant tempera
34、ture water tank at 20 t l0C for not less than 30 min, and add dilution solution kept similarly in a constant temperature water tank at 20 t l0C for not less than 30 min up to the marked line. 5OC or under. more after preparation shall not be used. Preserve the prepared standard solution at O to This
35、 standard solution elapsed by six months or (6) Glucose Standard Solution Weigh out glucose standard solution (1 w / v $) so correctly that the concentration described in the handling instruction is attained, put into a transfer flask, keep in a constant temperature water tank at 20 ? 1OC for not le
36、ss than 30 min, and add dilution solution which is kept similarly in a constant temperature water tank at 20 5 l0C for not less than 30 min up to the marked line. The solution prepared in accord- ance with this method as appropriate and fed by manufacturer may be taken as the glucose standard soluti
37、on. (7) Buffer Solution The buffer solution described in the handling instruction. 8.2 Testing Conditions The testing conditions shall be as follows: (1) Measuring Cell Temperature The measuring cell temperature described in the handling instruction. Environmental Temperature 2OoC up to and includin
38、g 3OoC Copyright Japanese Standards Association Provided by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/12/2007 08:27:56 MDTNo reproduction or networking permitted without license from IHS -,-,- 6 K 0701-1988 (3) Relative Humidity 65 5 20 %. Howe
39、ver, when the remarkable dew condensation is affirmed on the analyzer, it shall be lower humidity, (4) Power Source Voltage Rated voltage. (5) Preliminarily Operation preliminarily operation of about 30 min to stand by. Let the power source on and carry out ( 6 ) Calibration After preliminarily oper
40、ation carry out the calibra- tion by using glucose standard solution according to the method described in the handling instruction, 8.3 Test Methods (1) Repeatability Feed-in the glucose standard solution of the amount described in the handling instruction 10 times, obtain the standard deviation and
41、 the average value from the obtained data, and calculate the variation factor, (2) Zero Drift read out the indication values after lapse of time of 5 min and 1 h, and express the difference by the ratio to the full scale to allow it to be the zero drift. It may be recorded on a recorder, In the stat
42、e where the buffer solution is fed in, (3) Response Time In the state where the buffer solution is fed in a measuring cell, after the output current of enzyme electrode has reached a definite value, feed-in the glucose standard solu- tion of the concentration specified by manufacturer to record the
43、output current, and obtain the time until the difference of output currents at before and after feeding-in reaches 90 % of the final value. In this case, for the analyzer capable of actua- tion of batch style measure by the batch style, and let the adding amount of glucose standard solution be the s
44、pecified amount. Further for the analyzer capable of only the actuation of flow style, measure by the flow style, and continue to feed-in the glucose standard solution of measuring amount at a definite flow speed during measurement. (4) Stability Relative to Voltage Variation Obtain respectively the
45、 Tndard solution of the con- centration designated by manufacturer is fed in by a specified amount with keeping the power source voltage at the rated voltage and the indicated value when the same test is carried out with the power source voltage changed by 2 10 % of the rated voltage. following the
46、voltage variation to the indicated value when the rated voltage is kept to be the variation of indicated value. Allow the ratio of varied amount of indicated value (5) Insulation Resistance Measure the insulation resistance between the united power source terminals and the outer casing (earthed term
47、inal) in the state where the electric circuit of analyzer is closed by using a d.c. 500 V insulation resistance tester speci- fied in JIS C 1302. Copyright Japanese Standards Association Provided by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/12/
48、2007 08:27:56 MDTNo reproduction or networking permitted without license from IHS -,-,- J I S K*O?OL 88 4933608 0055457 3 W 7 K 0701-1988 (6) Withstand Voltage Examine the existence of abnormalities by applying a.c. voltage of 1000 V of rated frequency between the united power source terminals and the outer casing in the state where the electric circuit of analyzer is closed for 1 min. 9. Marking The analyzers shall be described by an indelible method with the following items : (1) Name and type name of analyzer determined by manufacturer (2) Divis