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GB/T 14233.1-2008 English PDF (GBT14233.1-2008)

GB/T 14233.1-2008 English PDF (GBT14233.1-2008)

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GB/T 14233.1-2008: Test methods for infusion, transfusion, injection equipment for medical use -- Part 1: Chemical analysis methods

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.
GB/T 14233.1-2008
GB
ICS 11.040.30
C 31
NATIONAL STANDARD
OF THE PEOPLE 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 Republic of China???
Standardization Administration of the PEOPLE 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 ??C ~ 30 ??C.
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 105??C~110 ??C. 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...

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