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GB/T 14233.1-1998 (GBT 14233.1-1998)

Chinese standards (related to): 'GB/T 14233.1-1998'
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GB/T 14233.1-2008English135 Add to Cart 0--10 minutes. Auto immediate delivery. Test methods for infusion, transfusion, injection equipment for medical use -- Part 1: Chemical analysis methods GB/T 14233.1-2008 Valid GBT 14233.1-2008
GB/T 14233.1-1998English225 Add to Cart 0--10 minutes. Auto immediate delivery. Infusion, transfusion, injection equipment for medical use--Part 1: Chemical analysis methods GB/T 14233.1-1998 Obsolete GBT 14233.1-1998
GB/T 14233.1-1993EnglishRFQ ASK Days<=3 Infusion, transfusion, injection equipment for medical use--Part 1: Chemical analysis methods GB/T 14233.1-1993 Obsolete GBT 14233.1-1993


   
BASIC DATA
Standard ID GB/T 14233.1-1998 (GB/T14233.1-1998)
Description (Translated English) Infusion, transfusion, injection equipment for medical use--Part 1: Chemical analysis methods
Sector / Industry National Standard (Recommended)
Classification of Chinese Standard C31
Classification of International Standard 11.040.20
Word Count Estimation 17,190
Date of Issue 1998/11/26
Date of Implementation 1999/2/1
Older Standard (superseded by this standard) GB/T 14233.1-1993
Quoted Standard GB 601-1988; GB 602-1988; GB 6682-1992; PRC Pharmacopoeia 1995
Adopted Standard ISO 8536-4-1998, IDT; ISO 8536-5-1992, IDT; ISO 1135-4-1998, IDT; ISO 3826-1993, IDT; ISO 7886-1-1993, IDT
Regulation (derived from) Announcement of Newly Approved National Standards No. 18, 2008 (No. 131 overall)
Proposing organization State Drug Administration
Issuing agency(ies) State Quality and Technical Supervision


GB/T 14233.1-1998: PDF in English (GBT 14233.1-1998)
GB/T 14233.1-1998
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.20
C 31
Replacing GB/T 14233.1-1993
Infusion, Transfusion, Injection Equipment for Medical
use - Part 1: Chemical Analysis Methods
ISSUED ON: NOVEMBER 26, 1998
IMPLEMENTED ON: FEBRUARY 01, 1999
Issued by: State Bureau of Quality and Technical Supervision
Replaced
Table of Contents
Foreword ... 4
1 Scope ... 6
2 Normative References ... 6
3 General ... 6
Chapter I -- Analysis Method of Dissolution Matter ... 7
4 Preparation of Test Solution ... 7
5 Inspection Items and Analysis Methods ... 8
5.1 Determination of turbidity and color ... 8
5.2 Reducing substances (easy oxides) ... 9
5.3 Chloride ... 12
5.4 pH value ... 13
5.5 Evaporation residue ... 14
5.6 Total content of heavy metal ... 14
5.7 UV absorbance ... 16
5.8 Ammonium ... 16
5.9 Some heavy metal elements ... 17
5.10 Sulfate ... 20
Chapter II -- Analysis Method of Material ... 21
6 Analysis Method of the Total Content of Heavy Metal ... 21
6.1 Principle ... 21
6.2 Preparation of reagents and solutions ... 21
6.3 Preparation of test solution ... 21
6.4 Test procedures ... 22
7 Analysis Method of the contents of some heavy metal elements ... 22
7.1 Atomic absorption spectrophotometer method ... 22
7.2 Colorimetric analysis method ... 22
8 Ignition Residues ... 23
8.1 Test procedures ... 23
8.2 Calculation of results ... 23
Chapter III -- Analysis Method of Ethylene Oxide Residue ... 23
9 Gas Chromatography (Arbitration) ... 23
9.1 Principle ... 23
9.2 Gas chromatograph conditions ... 24
9.3 Preparation of ethylene oxide standard stock solution ... 24
9.4 Specimen preparation ... 24
9.5 Test procedures ... 25
9.6 calculation of results ... 25
10 Colorimetric Analysis Method ... 26
10.1 Principle ... 26
10.2 Preparation of solution ... 26
10.3 Preparation of test solution ... 27
10.4 Test procedures ... 27
10.5 Calculation of result ... 27
Infusion, Transfusion, Injection Equipment for
Medical use - Part 1: Chemical Analysis Methods
1 Scope
This Standard specifies chemical analysis methods of infusion, transfusion, and
injection equipment for medical use.
This Standard is applicable to chemical analysis of infusion, transfusion, injection
equipment for medical use and supporting equipment made of medical polymer
materials. Chemical analysis of other medical polymer products can also use it as a
reference.
2 Normative References
The following standards contain provisions which, through reference in this Standard,
constitute provisions of this Standard. At the time of publication, the editions indicated
are valid. All standards are subject to revision. The parties who are using this Standard
shall explore the possibility of using the latest version of the following standards.
GB 601-1988 Chemical Reagent - Preparations of Standard Volumetric Solutions
GB 602-1988 Chemical Reagent – Preparations of the Formulation and Products
Used in the Test Method
GB 6682-1992 Water for Laboratory Use – Specifications (neq ISO 3696:1987)
People’s Republic of China Pharmacopoeia 2015 Edition
3 General
3.1 All analyses of this Standard are performed in two parallel test groups. The results
shall be within the allowable relative deviation range, and the arithmetic mean value
shall be used as the measurement result. If one is qualified, the other is unqualified,
then the arithmetic mean value shall not be calculated; it shall be re-tested.
3.2 Unless otherwise specified, the reagents used in this Standard are analytically pure.
3.3 If there is no special requirement for test water in this Standard, it shall meet the
requirements of Class-2 water specified in GB 6682.
water; and dilute to 1000mL after cooling.
b) c(KMnO4) = 0.02 mol/L potassium permanganate standard solution: the same as
5.2.1.2d).
c) c(KMnO4) = 0.002 mol/L potassium permanganate standard solution: the same
as 5.2.1.2.e).
d) Starch indicator liquid: take 0.5g of starch and dissolve it in 100mL of water; heat
and boil, then cool off for later-use.
e) c(Na2S2O3) = 0.1 mol/L sodium thiosulfate standard solution: take 26g of sodium
thiosulfate (Na2S2O3 • 5H2O) or 16g of anhydrous sodium thiosulfate; dissolve in
1000mL of water and slowly boil 10 minutes; cool off; add water to 1000mL. After
two weeks, filter it, and calibrate its concentration.
f) c(Na2S2O3) = 0.01 mol / L sodium thiosulfate standard solution: before use, take
0.1mol/L sodium thiosulfate standard solution and dilute it 10 times with freshly
boiled and cooled water.
5.2.2.3 c(Na2S2O3) = calibration of 0.1mol/L sodium thiosulfate solution
Take 0.15g of standard potassium dichromate and dry at 120°C to constant weight;
weigh accurately; place in an iodine volumetric flask; dissolve in 25mL of water; add
2g of potassium iodide and 20mL of dilute sulfuric acid (20% ); shake well; and place
in a dark place for 10min. Add 150mL of water and use the prepared sodium thiosulfate
solution [c(Na2S2O3) = 0.1mol/L] to titrate; add 3mL of starch indicator solution (5 g/L)
near the end point; and continue titration until the solution changes from blue to bright
green. At the same time, a blank test is performed.
5.2.2.4 Test procedures
Take 10mL1) of the test solution prepared in Clause 4; add it to a 250mL iodine
volumetric flask; add 1mL2) of dilute sulfuric acid and 10 mL1) of potassium
permanganate standard solution with the concentration specified in the product
standard; and boil for 3 min; cool quickly; add 0.1g 2) of potassium iodide; stopper and
shake well. Immediately titrate by the sodium thiosulfate standard solution with the
same concentration to the light yellow; add 0.25mL of starch indicator solution; and
continue to titrate by the sodium thiosulfate standard solution to colorless.
Titrate the blank control solution in the same way.
5.2.2.5 Calculation of results
The content of reducing substance (easy oxide) is expressed by the consumed amount
1) 20mL may also be used at the same time.
2) When using 20mL of test solution, add 2mL of dilute sulfuric acid; and 1.0g of potassium iodide.
Take 10mL of sodium chloride standard solution and place it in another 50mL Nessler
colorimetric tube; add 10mL of dilute nitric acid; add water to make it about 40mL; and
shake well to obtain the standard control solution.
Add 1mL of silver nitrate test solution to the above two test tubes; dilute to 50 mL by
water; place them in the dark place for 5min; and observe from above the colorimetric
tube on a black background. Then compare the turbidity between the test solution and
the standard control solution.
If the test solution is colored, unless otherwise specified, two portions of test solutions
may be taken; separately place them into 50mL Nessler colorimetric tubes; and one
portion is added with 1.0mL of silver nitrate test solution; shake well; stand for 10min.
If it is turbid, repeatedly filter it until the filtrate is completely clear; and then add the
standard sodium chloride solution and an appropriate amount of water to make it 50mL;
shake well; and place it in the dark for 5min as a control solution. add 1.0mL of silver
nitrate test solution and an appropriate amount of water to another portion to make it
50mL; shake well, place it in a dark place for 5min; then compare it with the control
solution according to the above method.
5.4 pH value
5.4.1 Method I
Take the test solution and the blank control solution prepared in Clause 4; measure
their pH values with an acidity meter; and use the difference between them as the test
result.
5.4.2 Method II
5.4.2.1 Preparation of solution
a) c(NaOH) = 0.1 mol/L sodium hydroxide standard solution: prepare and calibrate
according to 4.1 of GB 601-1988.
b) c(NaOH) = 0.01 mol/L sodium hydroxide standard solution: take 0.1 mol/L sodium
hydroxide standard solution and dilute with water by 10 times before use.
c) c(HCl) = 0.1 mol/L hydrochloric acid standard solution: prepare and calibrate
according to 4.2 of GB 601-1988.
d) c(HCl) = 0.01 mol/L hydrochloric acid standard solution: take 0.1 mol/L
hydrochloric acid standard solution and dilute it by 10 times with water before
use.
e) Tashiro indicator: dissolve 0.2g of methyl red and 0.1g of methylene blue in
100mL of ethanol [95% (V/V)].
a) Phenolphthalein indicator solution: take 1g of phenolphthalein and add 100mL of
ethanol.
b) Acetate buffer solution (pH 3.5): take 25g of ammonium acetate; add 25 mL of
water to dissolve; add 38mL of hydrochloric acid solution (7 mol/L); and use
hydrochloric acid solution (2 mol/L) or ammonia solution (5 mol/L) accurately
adjust the pH value to 3.5 (indicated by the potentiometric method); and dilute to
100mL by water.
c) Thioacetamide test solution: take 4g of thioacetamide; add water to dissolve it
into 100mL; and store it in the refrigerator. Before use, take 5.0mL of the mixed
solution [consisting of 15mL of sodium hydroxide (1 mol/L), 5.0mL of wate......