GB/T 14233.1-2022 English PDF (GBT14233.1-2022)

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GB/T 14233.1-2022: Test methods for infusion, transfusion, injection equipments for medical use -- Part 1: Chemical analysis methods
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]...