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 be carried out by reference to this Part.
2 Normative References
The following standards contain provisions which, through reference in this text, constitute provisions of this Part of GB/T 14233. For dated reference, subsequent amendments to (excluding correction to), or revisions of, any of these publications do not apply. However, the parties to agreements based on this standard are encouraged to investigate the possibility of applying the most recent editions of the standards. For undated references, the latest edition of the normative document referred to applies.
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 based on two parallel test groups; the test results shall be within the allowable relative deviation limits; arithmetic mean shall be adopted as the test result; in the case of one portion qualified and the other unqualified, the results shall not be averaged, and tests shall be carried out again instead.
3.2 Unless otherwise specified, all reagents used in this Part are analytically 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℃~ 30℃.
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 mass difference of test substance after twice continuous flaming or drying shall not exceed 0.3mg.
3.8 Unless otherwise specified, all glass vessels used in this Part are borate ones.
Contents Foreword i 1 Scope 2 Normative References 3 General Rules 4 Preparation for Test Solution 5 Analysis Methods for Leachables of Test Solution 6 Analysis Methods for the Total Content of Heavy Metal in Materials 7 Analysis Methods for the Element Content of Some Heavy Metals in Materials 8 Residue of Burning 9 Measurement of the Residual Quantity of Ethylene Oxide-Gas Chromatography 10 Residue Analysis of Ethylene Oxide-Colorimetric Analysis Bibliography
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 be carried out by reference to this Part.
2 Normative References
The following standards contain provisions which, through reference in this text, constitute provisions of this Part of GB/T 14233. For dated reference, subsequent amendments to (excluding correction to), or revisions of, any of these publications do not apply. However, the parties to agreements based on this standard are encouraged to investigate the possibility of applying the most recent editions of the standards. For undated references, the latest edition of the normative document referred to applies.
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 based on two parallel test groups; the test results shall be within the allowable relative deviation limits; arithmetic mean shall be adopted as the test result; in the case of one portion qualified and the other unqualified, the results shall not be averaged, and tests shall be carried out again instead.
3.2 Unless otherwise specified, all reagents used in this Part are analytically 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℃~ 30℃.
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 mass difference of test substance after twice continuous flaming or drying shall not exceed 0.3mg.
3.8 Unless otherwise specified, all glass vessels used in this Part are borate ones.
Contents of GB/T 14233.1-2008
Contents
Foreword i
1 Scope
2 Normative References
3 General Rules
4 Preparation for Test Solution
5 Analysis Methods for Leachables of Test Solution
6 Analysis Methods for the Total Content of Heavy Metal in Materials
7 Analysis Methods for the Element Content of Some Heavy Metals in Materials
8 Residue of Burning
9 Measurement of the Residual Quantity of Ethylene Oxide-Gas Chromatography
10 Residue Analysis of Ethylene Oxide-Colorimetric Analysis
Bibliography
