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GB/T 14233.1-2022
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.
solution and dilute to the required concentration.
Silver nitrate test solution (17.5 g/L): weigh-take 1.75 g of silver nitrate, dissolve it in water,
dilute to 100 mL and store it in a brown bottle.
Nitric acid solution: take 105 mL of nitric acid and use water to dilute to 1,000 mL.
5.3.3 Test procedures
Accurately measure-take 10 mL of the test solution, add it to a 50 mL Nessler colorimetric tube;
add 10 mL of dilute nitric acid (if the solution is not clear, filter it and place the filtrate in a 50
mL Nessler colorimetric tube), add water to make it about 40 mL. Thus, the test solution is
obtained.
Accurately measure-take 10 mL of the chlorine standard solution to another 50 mL Nessler
colorimetric tube; add 10 mL of dilute nitric acid; add water to make it about 40 mL; shake it
well. Thus, the standard control solution is obtained.
In the above-mentioned two test tubes, respectively add 1.0 mL of silver nitrate test solution,
use water to dilute to 50 mL; place it in a dark place for 5 min; place it on a black background
and observe from above the colorimetric tube. Compare the turbidity of the test solution with
the standard control solution.
If the test solution is colored, unless it is otherwise specified, take two portions of the test
solution and respectively place them in a 50 mL Nessler colorimetric tube. Add 1.0 mL of silver
nitrate test solution to one portion, shake it well and let it stand for 10 min. If it becomes turbid,
repeatedly filter it, until the filtrate is completely clear. Then, add the specified amount of
chlorine standard solution and an appropriate amount of water to make it 50 mL; shake it well
and place it in the dark for 5 min; use it as the control solution. Add 1.0 mL of silver nitrate test
solution to another portion and an appropriate amount of water to make it 50 mL. Shake it well
and place it in the dark for 5 min. In accordance with the above-mentioned method, compare it
with the control solution. Thus, the solution is obtained.
5.4 pH
5.4.1 Method 1
Take the test solution and the blank control solution. In accordance with the 0631 pH value
determination method of Pharmacopoeia of the People’s Republic of China (Version 2020) Four
Volumes, respectively determine the pH value and take the difference between them as the test
result.
5.4.2 Method 2
5.4.2.1 Solution preparation
Sodium hydroxide standard titration solution [c (NaOH) = 0.1 mol/L]: in accordance with the
stipulations of GB/T 601, prepare and titrate it.
Sodium hydroxide standard titration solution [c (NaOH) = 0.01 mol/L]: before use, take the
sodium hydroxide standard titration solution [c (NaOH) = 0.1 mol/L] and add water to dilute
10 times.
Hydrochloric acid standard titration solution [c (HCl) = 0.1 mol/L]: in accordance with the
stipulations of GB/T 601, prepare and titrate it.
Hydrochloric acid standard titration solution [c (HCl) = 0.01 mol/L]: before use, take the
hydrochloric acid standard titration solution [c (HCl) = 0.1 mol/L] and add water to dilute 10
times.
Tashiro indicator: dissolve 0.2 g of methyl red and 0.1 g of methylene blue in 100 mL of
methanol (with a volume fraction of 95%).
5.4.2.2 Test procedures
Accurately measure-take 20 mL of the test solution and place it in a 100 mL ground-mouth
bottle; add 0.1 mL of Tashiro indicator. If the color of the solution turns purple, then, use the
sodium hydroxide standard titration solution [c (NaOH) = 0.01 mol/L] to titrate it; if it turns
green, use the hydrochloric acid standard titration solution [c (HCl) = 0.01 mol/L] to titrate it,
until it turns gray. Take the volume (in mL) of the consumed sodium hydroxide standard
titration solution [c (NaOH) = 0.01 mol/L] or hydrochloric acid standard titration solution [c
(HCl) = 0.01 mol/L] as the test result.
5.4.3 Method 3
5.4.3.1 Solution preparation
Sodium hydroxide standard titration solution [c (NaOH) = 0.1 mol/L]: same as 5.4.2.1.
Sodium hydroxide standard titration solution [c (NaOH) = 0.01 mol/L]: same as 5.4.2.1.
Hydrochloric acid standard titration solution [c (HCl) = 0.1 mol/L]: same as 5.4.2.1.
Hydrochloric acid standard titration solution [c (HCl) = 0.01 mol/L]: same as 5.4.2.1.
Phenolphthalein indicating solution (10 g/L): weigh-take 1 g of phenolphthalein, dissolve it in
ethanol (with a volume fraction of 95%) and dilute to 100 mL.
Methyl red indicating solution (1 g/L): weigh-take 0.1 g of methyl red, dissolve it in ethanol
(with a volume fraction of 95%) and dilute to 100 mL.
5.4.3.2 Test procedures
Add 2 drops of the phenolphthalein indicating solution to 10 mL of test solution, and the
solution shall not turn red. Add 0.4 mL of the sodium hydroxide standard titration solution [c
(NaOH) = 0.01 mol/L], and the solution shall turn red. Add 0.8 mL of the hydrochloric acid
standard titration solution [c (HCl) = 0.01 mol/L], and the red color shall disappear. Add 5 drops
store it in the refrigerator. Before use, take 5 mL of the mixed solution [composed of 15 mL of
sodium hydroxide (1 mol/L), 5 mL of water and 20 mL of glycerin], add 1 mL of the above-
mentioned thioacetamide solution; place it on a water bath to heat for 20 s, cool it down and
immediately use it.
Lead standard stock solution (0.1 mg/mL): weigh-take 0.160 g of lead nitrate, use 10 mL of
nitric acid solution (1 + 9) to dissolve it, then, transfer it into a 1,000 mL volumetric flask and
use water to dilute to the scale.
Lead standard solution: before use, accurately measure-take the lead standard stock solution
and dilute it to the required concentration.
5.6.1.3 Test procedures
Accurately measure-take 25 mL of the test solution in a 25 mL Nessler colorimetric tube; take
another 25 mL Nessler colorimetric tube and add 25 mL of the lead standard solution.
Respectively add 2 mL of acetate buffer solution (pH 3.5) to the above-mentioned two
colorimetric tubes, then, respectively add 2 mL of thioacetamide test solution, let it stand for 2
min. Place it on a white background and observe from above; 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, so as to make it
consistent with the color of the test solution. Then, 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. Place it on a white background and observe from above; compare the color shades.
Alternatively, take 10 mL of the test solution, then, the amount of lead standard solution added
is 10 mL.
5.6.2 Method 2
5.6.2.1 Principle
In an alkaline solution, heavy metals, such as: lead, chromium, copper and zinc, can react with
sodium sulfide to generate insoluble colored sulfides. Take lead as a representative to prepare
a standard solution for colorimetric comparison and determine the total content of the heavy
metals.
5.6.2.2 Solution preparation
Sodium hydroxide test solution (43 g/L): take 4.3 g of sodium hydroxide and add water to
dissolve it to 100 mL. Thus, the solution is obtained.
Sodium sulfide test solution (100 g/L): before use, weigh 1 g of sodium sulfide and add water
to dissolve it to 10 mL. Thus, the solution is obtained.
Lead standard stock solution (0.1 mg/mL): same as 5.6.1.2.
Lead standard solution: same as 5.6.1.2.
5.6.2.3 Test procedures
Accurately measure-take 25 mL of the test solution in a 25 mL Nessler colorimetric tube; take
another 25 mL Nessler colorimetric tube and add 25 mL of the lead standard solution.
Respectively add 5 mL of the sodium hydroxide test solution to the above-mentioned two
colorimetric tubes, then, respectively add 5 drops of the sodium sulfide test solution and shake
it well. Place it on a white background and observe from above; compare the color shades.
5.7 UV Absorbance
Take the test solution, if necessary, use a 0.45 m microporous filter membrane to filter it.
Within 5 h, use a 1 cm cuvette with the blank control solution as a reference. Within the
specified wavelength range, determine the absorbance.
5.8 Ammonium
5.8.1 Principle
Ammonium ions can react with Nessler reagent in alkaline solution to generate a yellow
substance. Through colorimetric comparison with the standard control solution, determine its
ammonium content.
5.8.2 Solution preparation
Sodium hydroxide solution (40 g/L): weigh-take 4.0 g of sodium hydroxide, use water to
dissolve and dilute it to 100 mL.
Nessler reagent (alkaline potassium mercuric iodide test solution): take 10 g of potassium iodide,
add 10 mL of water to dissolve it, then, slowly add a saturated aqueous solution of mercuric
dichloride, stir as it is added, until the generated red precipitate is no longer dissolved. Add 30
g of potassium hydroxide and dissolve it, then, add 1 mL or above of a saturated aqueous
solution of mercuric dichloride, and use an appropriate amount of water to dilute it to 200 mL;
let it stand and precipitate. Thus, the solution is obtained. During use, pour off the supernatant.
Inspection: take 2 mL of this solution, add it to 50 mL of water containing 0.05 mg of ammonia,
and it shall immediately appear yellowish brown.
Ammonium standard stock solution (0.1 mg/mL): weigh-take 0.297 g of ammonium chloride
dried to a constant mass at 105 C ~ 110 C; use water to dissolve and dilute it to 1,000 mL.
Ammonium standard solution: before use, accurately measure-take the ammonium standard
stock solution and dilute to the required concentration.
5.8.3 Test procedures
Accurately measure-take 10 mL of the test solution in a 25 mL Nessler colorimetric tube; take
another 25 mL Nessler colorimetric tube and add 10 mL of the ammonium standard solution.
5.9.3 Atomic fluorescence spectrometry
5.9.3.1 Instrument
Atomic fluorescence spectrophotometer. During use, operate it in accordance with the
instruction manual.
5.9.3.2 Analysis method (standard curve method)
Within the concentration range recommended by the atomic fluorescence spectrophotometer,
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,
take the solvent used to prepare the standard solutions as a blank and successively determine
the fluorescence intensity 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.
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.
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.
9.3 Sample Extraction Methods
9.3.1 General rule
There are three basic sample extraction methods for the determination of ethylene oxide residue
on medical devices sterilized with ethylene oxide: simulated use extraction method, stringent
extraction method and extreme extraction method.
The simulated use extraction method refers to the method that makes the extraction simulate
the use of the product as much as possible. This simulation process allows the measured residual
ethylene oxide to correspond to the actual ethylene oxide intake of the patient using the device.
The stringent extraction method is an extraction that is expected to result in the release of greater
or a larger amount of chemical constituents than under clinical use conditions.
The extreme extraction method means that the amount of ethylene oxide determined in the
second extraction is less than 10% of the value determined in the first extraction, or the
cumulative residual amount determined by extraction has no obvious increase.
The extract should be prepared after sampling, otherwise, the test sample shall be sealed in a
metal container sealed with polytetrafluoroethylene for preservation.
When citing the method of this document, if no extraction method is specified, then, it shall be
carried out in accordance with the extreme extraction method or the stringent extraction method.
9.3.2 Simulated use extraction method
9.4.3 Draw a standard curve
Use the stock solution to prepare standard solutions with at least 5 series of concentrations
ranging from 1 g/mL ~ 20 g/mL. Accurately measure-take 5 mL and place it in a 20 mL
extraction vessel, seal it; at a constant temperature (60 C 1 C), balance it for 40 min.
Use a sample injector to successively and quickly take the upper part of gas from the balanced
standard sample, inject it into the sample injection chamber and record the peak height (or area)
of ethylene oxide. Draw a standard curve (X: mass concentration of ethylene oxide, g/mL; Y:
peak height or area).
9.4.4 Measurement of test sample
Use the sample injector to quickly take the upper part of gas from the balanced specimen
extraction vessel, inject it into the sample injection chamber and record the peak height (or area)
of ethylene oxide.
In accordance with the standard curve, calculate the corresponding concentration of the sample.
If the result of the measured sample is beyond the range of the standard curve, the concentration
of the standard solution shall be changed to re-draw the standard curve.
9.4.5 Recommended chromatographic conditions
Chromatographic column: the stationary phase is generally 6% cyanopropyl benzene and 94%
dimethyl siloxane.
Injection port temperature: 200 C.
Column flow rate: 1.5 mL/min.
Detector: FID.
Split ratio: 20 : 1.
Column oven temperature: maintain at 50 C for 8 min.
Detector temperature: 250 C.
Other validated chromatographic conditions may also be adopted.
9.5 Result Calculation
The residual amount of ethylene oxide is expressed by the absolute content or relative content.
9.5.1 In accordance with Formula (5), calculate the absolute content of ethylene oxide per unit
of product:
......
GB/T 14233.1-2008
GB
ICS 11.040.30
C 31
NATIONAL STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
Replacing GB/T 14233.1-1998
Test Methods for Infusion, Transfusion, Injection
Equipments for Medical Use -
Part 1. Chemical Analysis Methods
ISSUED ON. NOVEMBER 3, 2008
IMPLEMENTED ON. OCTOBER 1, 2009
Issued by.
General Administration of Quality Supervision, Inspection
and Quarantine of the People’s Republic of China；
Standardization Administration of the People’s Republic of
China
Table of Contents
Foreword ... 3
1 Scope ... 5
2 Normative references ... 5
3 General Rules ... 5
4 Preparation of Test Solution ... 6
5 Analysis Methods for Leachables of Test Solution ... 8
6 Analysis Methods for the Total Content of Heavy Metal in Materials ... 25
7 Analysis Methods for the Element Content of Some Heavy Metals in Materials ... 26
8 Residue of Burning ... 28
9 Measurement of the Residual Quantity of Ethylene Oxide-Gas Chromatography ... 29
10 Residue Analysis of Ethylene Oxide-Colorimetric Analysis ... 32
Bibliography ... 36
Foreword
GB/T 14233 "Test methods for infusion, transfusion, injection equipments for medical use"
is divided into two parts.
— Part 1. Chemical analysis methods;
— Part 2. Biological test methods.
This Part is Part 1 of GB/T 14233.
This Part replaces GB/T 14233.1-1998 "Test methods for infusion, transfusion, injection
equipments for medical use-Part 1. Chemical analysis methods". In considering that the
GB/T 14233.1-1998 has been widely cited by many product standards, in order to avoid
the confusion due to changes of the clause numbers, the clause numbers in this Part are
kept as unchanged as possible to the corresponding clause numbers in the previous
version. Therefore, the contents which need to be modified are revised under the previous
clause numbers. For newly-added contents, new clause numbers and methods are added
on top of previous clause numbers.
Compared with GB/T 14233.1-1998, this Part has the following major changes.
— MODIFY solution preparation and expression methods;
— ADD preparation methods of test solutions - for products such as irregular products
with short service time (shorter than 24 hours) and larger volume, irregular-shape
products with longer service time (longer than 24 hours), and water absorbing
materials;
— ADD turbidity and luster test methods;
— MODIFY test methods for chloride, pH value, heavy metal, ammonium, zinc, ignition
residue, ethylene oxide residue content;
— ADD atomic fluorescence spectroscopy test method;
— DELETE sulphate test method.
This Part was proposed by the State Food and Drug Administration.
This Part is under the jurisdiction of National Technical Committee on Medical Syringes of
Standardization Administration of China.
Drafting organization of this Part. Jinan Quality Supervision and Inspection Center for
Medical Devices.
Chief drafting staffs of this Part. Luo Hongyu, Pan Huaxian, Shi Yanping, Sun Guangyu, Li
Kefang, Qin Dongli, Liu Bin, Liu Lili, and Guo Lun.
The previous standard replaced by this Part are.
- GB/T 14233.1-1993;
- GB/T 14233.1-1998.
Test Methods for Infusion, Transfusion, Injection Equipments
for Medical Use - Part 1. Chemical Analysis Methods
1 Scope
This Part of GB/T 14233 specifies the chemical analysis methods for infusion, transfusion,
injection equipments for medical use.
This Part is applicable to the chemical analysis for infusion, transfusion, injection and
supporting equipments for medical use made of medical macromolecular materials. The
chemical analysis for other medical macromolecular products may also adopt this Part for
reference.
2 Normative references
The articles contained in the following documents have become part of this Part when
they are quoted herein. For the dated documents so quoted, all the modifications
(excluding corrections) or revisions made thereafter shall not be applicable to this Part.
For the undated documents so quoted, the latest editions shall be applicable to this Part.
GB/T 601 Chemical reagent - Preparations of Standard volumetric solutions
GB/T 6682 Water for Analytical Laboratory Use - Specification and Test Methods (GB/T
6682-2008, ISO 3696.1987, MOD)
Pharmacopoeia of People's Republic of China (2005 Edition) Volume II
3 General Rules
3.1 All analysis in this Part shall be carried out and based on 2 parallel test groups. The
test results shall be within the allowable relative deviation limits. Arithmetic mean shall be
adopted as the test result. If one result is qualified and the other one is unqualified, the
results shall not be averaged. And tests shall be re-performed.
3.2 Unless otherwise specified, all reagents used in this Part are analytical pure.
3.3 Unless otherwise specified, all test water in this Part shall meet the requirements of
Class II water in GB/T 6682.
3.4 Term "room temperature" in this Part refers to 10 ºC ~ 30 ºC.
3.5 Term "accurate weighing" in this Part refers to weighing to the accuracy of 0.1mg.
3.6 Term "accurate measuring" in this Part refers to measure with pipette meeting the
requirements of the accuracy specified by corresponding national standards.
3.7 Gravimetric method constant weight refers to that the mass difference of test
substance between 2 consecutive flamings or dryings shall not exceed 0.3mg.
3.8 Unless otherwise specified, all glass vessels used in this Part are borate glass
containers.
4 Preparation of Test Solution
4.1 During the preparation of test solution, it shall simulate as possible the conditions
endured during the product usage process (such as the application area, time and
temperature of the product). Simulated leaching time shall not be shorter than the product
normal usage time. Where the service time of products is relative long (longer than 24
hours), test solution shall be prepared in consideration of accelerated test conditions,
however, the feasibility and rationality shall be verified.
4.2 Methods used for preparing test solution shall meet as possible that all tested surfaces
of samples SHOULD be extracted.
4.3 It is recommended to choose the preparation method of test solution from Table 1.
iodide. Dissolve it in 10mL water. Slowly add saturated water solution of mercury
bichloride and stir at the same time until generating red precipitation and without
dissolution. Add and dissolve 30g of potassium hydroxide. Add 1mL or more saturated
water solution of mercury bichloride. Dilute it to 200mL with adequate amount of water.
Lay it aside to precipitate. Take the supernatant liquor for use. Inspection. Take 2mL of the
above-prepared solution. And after adding 50mL of water with 0.05mg ammonia, the
solution shall present yellow-brown color immediately.
Ammonium standard stock solution (0.1 mg/mL). Weigh 0.297g of ammonium chloride.
Dry to constant weight at 105ºC~110 ºC. Dissolve it in water and dilute to 1000mL.
Ammonium standard solution. Accurately measure ammonium standard stock solution
before use. And dilute it to the required concentration.
5.8.3 Test procedure
Accurately measure 10mL of test solution. Pour it into a 25mL Nessler tube. Take another
25mL Nessler tube. Add 10mL of ammonium standard solution. Respectively add 2mL of
sodium hydroxide solution (40g/L) into above-mentioned two tubes to make the solution
alkaline. Dilute the solution to 15mL with distilled water. And then add 0.3mL of Nessler
reagent.
Inspect the solutions after 30s. Compare the colors of test solution and control solution.
5.9 Some heavy metal elements
5.9.1 Atomic absorption spectrophotometer method
5.9.1.1 Instrument
Atomic absorption spectrophotometer shall be operated according to the instrument’s
instructions when using.
5.9.1.2 Analysis method (standard curve method)
Within the recommended concentration range of instrument, prepare at least five standard
solutions of which the concentrations are incremented in sequence and which contain the
elements to-be-determined. Use the solvent which is used in standard solution
preparation to adjust the absorbance to zero. Determine the absorbance of each standard
solution. And draw the standard curve of absorbance to concentration.
Atomic fluorescence spectrophotometer shall be operated according to the instrument’s
instructions when using.
7.3.3 Analysis Method
Within the recommended concentration range by instrument, prepare at least five
standard solutions (containing to-be-determined elements) of which the concentrations
are incremented in sequence. Use the solvent which is used to prepare standard solution
to zero-set the absorbance. And then measure the absorbance of each standard solution
in turn. And make the standard curve relative to the concentration.
Measure the test solution prepared and blank control solution. Find out the corresponding
concentration on the standard curve according to absorbance. Calculate the content of
elements...
......
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 water and
20mL of glycerol]; add 1.0 mL of the above thioacetamide solution; and heat on
a water bath for 20s; cool and use immediately.
d) Lead standard stock solution: take 0.1598g of lead nitrate dried to constant
weight at 110°C and put it in a 1000mL volumetric flask; add 5mL of nitric acid
and 50mL of water; and dilute to the mark with water after dissolution; and shake
well; and take as the standard stock solution; the lead concentration is 100 µg/mL.
e) Lead standard solution: before use, accurately measure the lead standard stock
solution and dilute it to the required concentration.
5.6.1.3 Test procedures
Take 50mL of the test solution prepared in Clause 4 in a 50mL Nessler colorimeter
tube. Take another 50mL Nessler colorimeter tube; add 1mL of lead standard solution;
and dilute to 50 mL with water. Separately add 2mL of acetate buffer solution (pH 3.5)
to each colorimetric tube; and then separately add 2mL of thioacetamide test solution
each tube; shake well; and stand for 2min. Observe from the top on a white background;
compare the color depth.
5.6.2 Method II
5.6.2.1 Principle
In alkaline solutions, heavy metals such as lead, chromium, copper, and zinc can
interact with sodium sulfide to form insoluble colored sulfides. Take lead as the
representative metal to prepare the standard solution for colorimetry; and the total
content of heavy metals was determined.
5.6.2.2 Solution preparation
a) Sodium hydroxide test solution: take 4.3g of sodium hydroxide and add water to
dissolve it into 100mL.
b) Sodium sulfide test solution: take 1g of sodium sulfide and add water to dissolve
ammonium chloride standard stock solution to the required concentration.
5.8.3 Test procedures
Take 10mL of the test solution prepared in Clause 4 in colorimetric tube with a stopper;
and take another 10mL of ammonium chloride standard solution in another colorimetric
tube. Add 1mL of sodium hydroxide to each of the two tubes and 1 mL of Nessler's
reagent; mix well; after 5min, compare the color depth of the solution in the two
colorimetric tubes.
5.9 Some heavy metal elements
5.9.1 Atomic absorption spectrophotometer method
5.9.1.1 Method summary
Prepare the test solution according to Clause 4; and measure the content of each
element with atomic absorption spectrophotometer.
5.9.1.2 instruments
The atomic absorption spectrophotometer shall be operated according to the
instrument's instruction manual.
5.9.1.3 Analysis method (standard curve method)
Within the recommended concentration range of the instrument, prepare at least 3
standard solutions containing the elements to be measured and their concentrations
are increased in order; and adjust the absorbance of the solvent used to prepare the
standard solution to zero. Then measure the absorbance of each standard solution in
turn; and make a standard curve with respect to the concentration.
Determine the test solution and blank control solution prepared according to Clause 4;
find out the corresponding concentration on the standard curve according to the
absorbance; and calculate the element content.
NOTE: When measuring the content of heavy metals by atomic absorption spectrometry, the
test range can be increased by concentrating the test solution by evaporation. For the
determination of each metal, 2.5 mL of a hydrochloric acid solution with a mass concentration
of ρ(HCl) = 10 g/L was added to 250 mL of the test solution.
5.9.2 Colorimetric analysis method
5.9.2.1 Zinc
5.9.2.1.1 Principle
The reaction between zinc and zinc reagent developed the absorbance at 620nm.
cs – concentration of heavy metal corresponding to the test solution, in µg/mL;
cr – concentration of heavy metal corresponding to the standard control solution, in
µg/mL;
As – absorbance of the test solution;
At – absorbance of the standard control solution.
5.9.2.2 Lead
5.9.2.2.1 Principle
Lead ions form a red complex with dithizone chloroform solution under weak alkaline
(pH 8.6~11) conditions.
5.9.2.2.2 Preparation of reagents and solutions
a) 0.1% dithizone chloroform stock solution: take 0.10g of dithizone and dissolve in
chloroform; dilute to 100mL; store in brown bottle; and then place in refrigerator.
If dithizone is not pure, it can be purified by the following method: take 0.20g of
dithizone; dissolve it in 100mL of chloroform; filter it in a 250mL funnel through
absorbent cotton; and use 20mL of 3% (V/V) ammonia to repeatedly extracted
for several times until the chloroform phase is almost green. Merge water phase
into another separatory funnel and wash the water phase twice with 10mL of
chloroform each time. The chloroform phase was discarded; and the water phase
was acidified by 10% (V/V) sulfuric acid to separate out the dithizone; and then
extract twice by 100mL of chloroform each time. The chloroform phases were
combined and poured into a brown bottle.
b) Dithizone chloroform solution with absorbance of 0.15 (transmittance of 70%):
before use, take an appropriate amount of dithizone chloroform stock solution
and dilute with chloroform to an absorbance of 0.15 (wavelength 510nm, 1cm
cuvette).
c) Phenol red indicator solution: take 0.1g of phenol red and dissolve it in 100mL of
ethanol.
d) 50% ammonium citrate solution: take 50g of ammonium citrate and dissolve it in
100mL of water; take phenol red as an indicator; alkalize it by ammonia water
(pH 8.5~9); extract by the dithizone stock solution; 20mL each time, until
dithizone turns green. The chloroform layer was discarded, and the water layer
was washed by chloroform for several times; 25mL each time, until the
chloroform layer was colorless. The chloroform layer was discarded and the
water layer was taken.
and dilute to 100mL.
d) Acetic acid solution (300 g/L): take 30mL of glacial acetic acid; add 100mL of
water; and shake well.
5.10.2 Test procedures
Pipette 0.75mL of 95% ethanol solution into a colorimetric tube with a stopper; add
0.5mL of barium chloride solution and 0.25mL of acetic acid solution; add 1.5mL of
sulfate standard solution under continuous shaking conditions; and mix then shake for
30s; take 15mL of test solution; and add 0.3mL of acetic acid solution to acidify. This
acidified solution was added to the above mixture.
Use 15mL of sulfate standard solution with the mass concentration ρ(SO42-) = 10 mg/L;
prepare the control suspension in the same way.
Check after 5 min, the suspension must not be more turbid than the control solution.
Chapter II -- Analysis Method of Material
6 Analysis Method of the Total Content of Heavy Metal
6.1 Principle
In weakly acidic solutions, heavy metals such as lead, cadmium, copper, and zinc can
interact with thioacetamide to form insoluble colored sulfides. Use lead standard
solution as a standard for colorimetry to determine their total content.
6.2 Preparation of reagents and solutions
Performed as described in 5.6.1.2.
6.3 Preparation of test solution
Take 2g of sample and cut it into 5mm×5mm pieces; put them into a porcelain crucible;
slowly heat to carbonize; add 2mL of nitric acid and 5 drops of sulfuric acid after cooling;
and heat until the white smoke disappears. Burn at 500°C~550°C to make them ash;
after cooling, add 2mL of hydrochloric acid; and place on a water bath and evaporate
to dryness; add 3 drops of hydrochloric acid to wet the residue; add 10mL of water;
heat for 2 minutes; add a drop of phenolphthalein test solution; and then add ammonia
test solution until the above solution turns reddish. Add 2mL of acetate buffer solution
(pH 3.5) (if turbid, filter, and wash the precipitate with 10mL of water); transfer the
solution into a 50mL volumetric flask; and add water to make a 50mL test solution.
Place another porcelain crucible with 2mL of nitric acid, 5 drops of sulfuric acid and
2mL of hydrochloric acid on a water bath to evaporate to dryness; and then wet the
residue with 3 drops of hydrochloric acid. The following operations are the same as the
preparation method of the test solution, making it a blank control solution.
6.4 Test procedures
Take 50mL of the test solution and add it to a 50mL Nessler colorimetric tube. Add
another 1mL of lead standard solution to another 50mL Nessler colorimetric tube and
add the blank control solution to 50mL. Separately add 2mL of thioacetamide test
solution to each of the two colorimetric tubes; shake well; and stand for 2min. Observe
from above on a white background, compare the color depth.
7 Analysis Method of the contents of some heavy metal
elements
7.1 Atomic absorption spectrophotometer method
7.1.1 Method summary
The test solution was prepared according to 6.3, and the content of each element was
measured by atomic absorption spectrophotometer.
7.1.2 Instrument
The atomic absorption spectrophotometer shall be operated according to the
instrument's instruction manual.
7.1.3 Analysis method (standard curve method)
Within the recommended concentration range of the instrument, prepare at least 3
standard solutions containing the elements to be measured and their concentrations
are increased in order; and adjust the absorbance of the solvent used to prepare the
standard solution to zero. Then measure the absorbance of each standard solution in
turn, and make a standard curve with respect to the concentration.
Determine the test solution and blank control solution prepared according to 6.3; find
out the corresponding concentration on the standard curve according to the
absorbance; and calculate the content of the element.
7.2 Colorimetric analysis method
7.2.1 Zinc
Prepare the test solution and blank control solution according to 6.3 and perform
9.4.2 Cut the sample into 5mm long pieces; take 2.0g of it into the extraction container;
add 10mL of water; keep 40mL of head space. The pressure in the container is normal
pressure; and place in a constant temperature water bath at 60°C±1°C for 20min.
9.5 Test procedures
9.5.1 Use the stock solution to prepare a standard solution with six series
concentrations of 1×10-3 g/L ~ 1×10-2 g/L. Separately take 10mL each and process
according to 9.4.2.
Use a glass syringe to quickly take 1mL of the upper gas from the equilibrated standard
sample and specimen in order; and inject it into the injector; and record the peak height
(or area) of ethylene oxide.
NOTE 1: Use one person as much as possible in one analysis and use the same 1mL glass
syringe;
NOTE 2: The syringe is made the same constant temperature as the sample in advance;
NOTE 3: Pay attention to the change in the retention time of ethylene oxide every time to
prevent gas leakage from the injection vaporization pad;
NOTE 4: Each sample (including the standard sample) is analyzed for three times in the
shortest time as much as possible. Two of the three analyses must have a difference of no
more than 5%, otherwise the sample shall be reanalyzed.
9.5.2 Use the measured data of the standard sample to draw a standard curve (X: EO
concentration, g/L; Y: peak height or area).
9.5.3 Find out the corresponding concentration of the sample from the standard curve.
If the measured sample results are not in the range of the standard curve, the
concentration of the standard solution shall be changed and the standard curve re-
created.
9.6 calculation of results
The residual amount of ethylene oxide is expressed by an absolute content or a relative
content.
9.6.1 Calculate the absolute content of ethylene oxide in the sample according to
Formula (6):
Where:
WEO – absolute content of ethylene oxide per unit product, in mg;
......
| Standard ID | GB/T 14233.1-2022 (GB/T14233.1-2022) | | Description (Translated English) | Test methods for infusion, transfusion, injection equipments 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 | 18,136 | | Date of Issue | 2022-10-14 | | Date of Implementation | 2023-11-01 | | Older Standard (superseded by this standard) | GB/T 14233.1-2008 | | Drafting Organization | Shandong Provincial Institute of Medical Devices and Drug Packaging Inspection, Suzhou Better Medical Supplies Co., Ltd., Shandong Weigao Group Medical Polymer Products Co., Ltd. | | Administrative Organization | National Standardization Technical Committee of Medical Infusion Sets (SAC/TC 106) | | Proposing organization | State Drug Administration | | Issuing agency(ies) | State Administration for Market Regulation, National Standardization Management Committee | | Standard ID | GB/T 14233.1-2008 (GB/T14233.1-2008) | | Description (Translated English) | Test methods for 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 | 19,19 | | Date of Issue | 2008-11-03 | | Date of Implementation | 2009-10-01 | | Older Standard (superseded by this standard) | GB/T 14233.1-1998 | | Quoted Standard | GB/T 601; GB/T 6682; Chinese Pharmacopoeia (2005 edition) two | | Drafting Organization | Jinan, the State Food and Drug Administration Medical Device Quality Supervision and Inspection Center | | Administrative Organization | National Standardization Technical Committee medical infusion | | Regulation (derived from) | National Standard Approval Announcement 2008 No.18 (Total No.131) | | Proposing organization | State Food and Drug Administration | | Issuing agency(ies) | Administration of Quality Supervision, Inspection and Quarantine of People's Republic of China; Standardization Administration of China | | Summary | This standard specifies the medical pumping fluid, blood, injection equipment for chemical analysis. This section applies to medical infusion medical polymer materials, blood transfusion, chemical injection apparatus and supporting analysis, chemical analysis of other medical polymer products may also refer to adopt. | | 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 |
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