GB/T 14233.1-2022 PDF English
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Test methods for infusion, transfusion, injection equipment for medical use - Part 1: Chemical analysis methods
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| GB/T 14233.1-2008 | English | 135 |
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Test methods for infusion, transfusion, injection equipment for medical use -- Part 1: Chemical analysis methods
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Infusion, transfusion, injection equipment for medical use--Part 1: Chemical analysis methods
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GB/T 14233.1-2022: Test methods for infusion, transfusion, injection equipment for medical use - Part 1: Chemical analysis methods
---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/GBT14233.1-2022
GB
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.20
CCS C 31
Replacing GB/T 14233.1-2008
Test Methods for Infusion, Transfusion, Injection Equipment
for Medical Use - Part 1.Chemical Analysis Methods
Issued on. OCTOBER 12, 2022
Implemented on. NOVEMBER 1, 2023
Issued by. State Administration for Market Regulation;
Standardization Administration of the People’s Republic of China.
Table of Contents
Foreword... 3
Introduction... 5
1 Scope... 6
2 Normative References... 6
3 Terms and Definitions... 6
4 General Rules... 6
5 Analysis Methods of Extractable Matters of Test Solution... 9
6 Analysis Method of Total Content of Heavy Metals in the Materials... 19
7 Content Analysis Methods of Some Heavy Metal Elements in the Materials... 20
8 Residue on Ignition... 22
9 Determination of Ethylene Oxide Residue - Gas Chromatography... 23
Bibliography... 27
Test Methods for Infusion, Transfusion, Injection Equipment
for Medical Use - Part 1.Chemical Analysis Methods
1 Scope
This document specifies the chemical analysis methods for the infusion, transfusion and
injection equipment for medical use.
This document is applicable to the chemical analysis of the infusion, transfusion, injection and
supporting equipment for medical use and made of medical polymer materials. The chemical
analysis of other medical polymer products can also take this document as a reference.
2 Normative References
The contents of the following documents constitute indispensable clauses of this document
through the normative references in this text. In terms of references with a specified date, only
versions with a specified date are applicable to this document. In terms of references without a
specified date, the latest version (including all the modifications) is applicable to this document.
GB/T 601 Chemical Reagent - Preparations of Standard Volumetric Solutions
GB/T 6682 Water for Analytical Laboratory Use - Specification and Test Methods
Pharmacopoeia of the People’s Republic of China (Version 2020) Four Volumes
3 Terms and Definitions
This document does not have terms or definitions that need to be defined.
4 General Rules
4.1 Overview
4.1.1 All analyses in this document are carried out in two parallel test groups; the results shall
be within the allowable relative deviation limit; the arithmetic mean shall be taken as the
determination result. If one is qualified and the other is disqualified, the average calculation
shall not be performed and the determination shall be re-performed.
4.1.2 Unless it is otherwise specified, all reagents used in this document are analytically pure.
4.1.3 Unless it is otherwise specified, the test water in this document shall comply with the
requirements of Grade-2 water in GB/T 6682.
4.1.4 The term “room temperature” used in this document refers to 10 C ~ 30 C.
4.1.5 The term “accurate weighing” used in this document refers to weighing accurate to 0.1
mg.
4.1.6 The term “accurate measuring” used in this document refers to measuring with a transfer
pipette that complies with the accuracy requirements specified in the corresponding national
standards.
4.1.7 Constant weight by gravimetric method means that the weight difference of the test
sample after two consecutive ignitions or dryings shall not exceed 0.3 mg.
4.1.8 Unless it is otherwise specified, the glass containers used in this document are all
borosilicate glass containers.
4.1.9 Most of the analysis methods provided in this document are non-specific analysis methods,
and these methods can be used for the preliminary assessment of chemical hazards of medical
devices. However, if there is a situation that does not comply with the preliminary expectations
in a specific test, it does not suggest that the actual risk is unacceptable, and specific analysis
methods need to be adopted to identify and evaluate the safety.
4.2 Preparation of Test Solution
4.2.1 The preparation of the test solution shall simulate the conditions (such as. the application
area, time and temperature of the product, etc.) that the product goes through during the using
process as much as possible. The simulated extraction time shall not be less than the normal
use time of the product. When the product has been used for a long time (more than 24 h),
consideration should be given to prepare the test solution under accelerated test conditions, but
the feasibility and rationality need to be verified.
4.2.2 The methods used for the preparation of the test solution should try to extract all the tested
surfaces of the sample.
4.2.3 It is recommended to select the test solution preparation method in Table 1, and.
---If the sample preparation conditions in the brackets are used, it shall be indicated in the
product standard;
---The selection of temperature should take into account the highest temperature that the
product may be subject to in clinical use. For polymers, the temperature shall be
selected below the glass transition temperature.
5 Analysis Methods of Extractable Matters of Test Solution
5.1 Clarity and Color
5.1.1 Clarity
Comply with 0902 clarity inspection method of the Pharmacopoeia of the People’s Republic of
China (Version 2020) Four Volumes.
5.1.2 Color
Comply with 0901 solution color inspection method of the Pharmacopoeia of the People’s
Republic of China (Version 2020) Four Volumes.
5.2 Reducing Substances (readily oxidizable substances)
5.2.1 Method 1.direct titration method
5.2.1.1 Principle
Potassium permanganate us a strong oxidizing agent. In acidic medium, potassium
permanganate reacts with reducing substances, and MnO4 is reduced to Mn2+.
5.2.1.2 Solution preparation
Sulfuric acid solution. measure-take 128 mL of sulfuric acid and slowly inject it into 500 mL
of water; after cooling it down, dilute it to 1,000 mL.
Sodium oxalate solution [c (1/2Na2C2O4) = 0.1 mol/L]. weigh-take 6.700 g of sodium oxalate
dried at 105 C ~ 110 C to a constant mass; add water to dissolve and dilute it to 1,000 mL.
Sodium oxalate solution [c (1/2Na2C2O4) = 0.01 mol/L]. before use, take the sodium oxalate
solution [c (1/2Na2C2O4) = 0.1 mol/L] and add water to dilute 10 times.
Potassium permanganate standard titration solution [c (1/5KMnO4) = 0.1 mol/L]. in accordance
with the method in GB/T 601, prepare and calibrate it.
Potassium permanganate standard titration solution [c (1/5KMnO4) = 0.01 mol/L]. before use,
take the potassium permanganate standard titration solution [c (1/5KMnO4) = 0.1 mol/L] and
add water to dilute 10 times. If necessary, boil it, let it cool down, filter it, then calibrate its
concentration.
6 Analysis Method of Total Content of Heavy Metals in the
Materials
6.1 Principle
In a weakly acidic solution, heavy metals, such as. lead, cadmium, copper and zinc, can react
with thioacetamide to generate insoluble colored sulfides. By taking lead standard solution as
the standard for colorimetric comparison, their total content can be determined.
6.2 Preparation of Reagents and Solutions
Comply with 5.6.1.2.
6.3 Preparation of Test Solution
Take an appropriate amount of sample and cut into pieces of 5 mm 5 mm; put it into a
porcelain crucible; slowly blaze it, until it is completely charred, and let it cool. Then, add 0.5
mL ~ 1 mL of sulfuric acid to moisten it. At a low temperature, heat it, until the sulfuric acid
vapor disappears. Then, add 0.5 mL of nitric acid and evaporate it to dryness; after the nitrogen
oxide vapor is completely removed, let it cool. Then, at 500 C ~ 600 C, burn it to make it ash;
after it cools down. Add 2 mL of hydrochloric acid, place it on a water bath and evaporate it to
dryness, then add 15 mL of water. Add one drop of phenolphthalein test solution, then, dropwise
add the ammonia test solution, until the above-mentioned solution turns reddish. Add 2 mL of
acetate buffer solution (pH 3.5) and slightly heat to dissolve it (if there is any residue, it should
be filtered with filter paper), then, transfer the solution to a 25 mL Nessler colorimetric tube;
add water to make 25 mL of test solution.
Place another porcelain crucible added with 0.5 mL ~ 1 mL of sulfuric acid, 0.5 mL of nitric
acid and 2 mL of hydrochloric acid on a water bath to evaporate it to dryness. Add 2 mL of
acetate buffer solution (pH 3.5) and 15 mL of water, slightly heat to dissolve it, then, transfer
the solution to a 25 mL Nessler colorimetric tube. Add a certain amount of lead standard
solution, then, use water to dilute it to 25 mL; take it as the standard control solution.
6.4 Test Procedures
Respectively add 2 mL of thioacetamide test solution to the test solution and the standard
control solution; shake it well and let it stand for 2 min. On a white background, observe it from
above and compare the color shades.
If the test solution develops color, a small amount of dilute caramel solution or other non-
interfering colored solutions can be added to the standard control solution to make it consistent
with the color of the sample solution.
7 Content Analysis Methods of Some Heavy Metal Elements
in the Materials
7.1 Atomic Absorption Spectrophotometry
7.1.1 Sample digestion
7.1.1.1 Wet digestion. take 1 g ~ 2 g of sample, accurately weigh it and cut it into pieces of
about 5 mm 5 mm; place it in a 100 mL conical flask, add 30 mL of nitric acid and 1.25 mL
of sulfuric acid, shake it well and place it overnight; heat it on a hot plate for digestion. If there
are still undecomposed substances or the color becomes darker when the digestion solution
reaches about 10 mL, remove it and let it come down. Add 5 mL ~ 10 mL of nitric acid, then,
digest it to about 10 mL for observation. Repeat this two or three times, and pay attention to
avoid charring. Cool it down, add 25 mL of water, then evaporate it, until white fumes of
sulfuric acid are emitted. Cool it down, then, use water to transfer the content to a 50 mL
volumetric flask; add water to obtain 50 mL of test solution. Use the same method to prepare
the blank control solution.
7.1.1.2 Dry-ashing. take 1 g ~ 2 g of sample, accurately weigh it and place it in a crucible. Add
10 mL of magnesium nitrate solution with a mass concentration of 150 g/L and mix it well. At
low heat, evaporate it to dryness. Carefully cover 1 g of magnesium oxide on the dry residue,
char it, until there is no black smoke, then, at 550 C, ash it for 4 h. Take it out and let it cool;
carefully add 10 mL of hydrochloric acid (1 + 1) to neutralize the magnesium oxide and dissolve
the ash (if there is any residue, it should be filtered with filter paper). Transfer it to a 50 mL
volumetric flask, and add water to make 50 mL of test solution. Use the same method to prepare
the blank control solution.
7.1.1.3 Other methods. reasonably formulated in accordance with the sample composition and
process.
7.1.2 Instrument
Atomic absorption spectrophotometer. During use, operate it in accordance with the instruction
manual.
7.2 Inductively Coupled Plasma Emission Spectrometry and Mass Spectrometry
7.2.1 Instruments
Inductively coupled plasma emission spectrometer and inductively coupled plasma mass
spectrometer. During use, operate it in accordance with the instruction manual.
7.2.2 Analysis method (standard curve method)
Within the concentration range recommended by the instrument, at least 5 standard solutions
(excluding the zero point) containing the elements to be determined and with increasing
concentrations in sequence shall be prepared. The concentration range of the standard solutions
should consider the concentration of the element to be determined. Then, successively
determine the signal value of each standard solution; draw a standard curve relative to the
concentration.
Determine the test solution prepared in accordance with 7.1.1 and the blank control solution. In
accordance with the signal value, find out the corresponding concentration on the standard
curve; calculate the content of each element.
7.3 Atomic Fluorescence Spectrometry
7.3.1 Instrument
Atomic fluorescence spectrophotometer. During use, operate it in accordance with the
instruction manual.
7.3.2 Analysis method
Within the concentration range recommended by the instrument, at least 5 standard solutions
(excluding the zero point) containing the elements to be determined and with increasing
concentrations in sequence shall be prepared. The concentration range of the standard solutions
should consider the concentration of the element to be determined. Then, successively
determine the absorbance of each standard solution; draw a standard curve relative to the
concentration.
Determine the test solution and the blank control solution. In accordance with the absorbance,
find out the corresponding concentration on the standard curve; calculate the content of the
element.
8 Residue on Ignition
8.1 Test Procedures
Take an appropriate amount of sample and cut it into about 5 mm 5 mm, place it in a crucible
(m0) that has been burned to a constant mass, accurately weigh it and record it as m1.In a fume
hood, slowly burn it, until it is completely charred, and let it cool. Add 0.5 mL ~ 1 mL of sulfuric
acid to make it moist; at a low temperature, heat it, until the sulfuric acid vapor is completely
removed. At 700 C ~ 800 C, burn it, until it is completely ashed. Place it in a desiccator to
room temperature and weigh it. Then, at 700 C ~ 800 C, burn it to a constant mass. Weigh it
and record it as m2.
If the residue needs to be kept for heavy metal inspection, then, the burning temperature shall
be controlled at 500 C ~ 600 C.
9 Determination of Ethylene Oxide Residue - Gas
Chromatography
9.1 Instrument
Gas chromatograph. During use, operate it in accordance with the instruction manual.
9.2 Analysis Method
Any gas chromatography can be used as long as the analysis is proven to be reliable. “Analytical
reliability” means that when determining a device with a specified residual amount of ethylene
oxide (EO), the selected analysis method has sufficient accuracy, precision, selectivity, linearity
and sensitivity, and suitable for the device to be analyzed.
For different products, necessary methodological evaluation is required to determine the
reliability of the selected method.
Other validated analysis methods may also be adopted, for example, mass spectrometry.
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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