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 infusion, transfusion, injection equipment for medical use.
This document is applicable to the chemical analysis for infusion, transfusion, injection and supporting equipment for medical use made of medical high polymer materials, and reference may be made to it for other medical high polymer products.
2 Normative references
The following documents contain provisions which, through reference in this text, constitute indispensable provisions of this document. For undated references, the latest edition of the referenced document (including any amendments) applies.
GB/T 601 Chemical reagent - Preparations of reference titration solutions
GB/T 6682 Water for analytical laboratory use - Specification and test methods
Pharmacopoeia of the People's Republic of China (Edition 2020) Volume IV
3 Terms and definitions
No terms and definitions apply for the purposes of this standard.
4 General
4.1 Overview
4.1.1 All analysis in this document 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; if one group is qualified, but the other unqualified, the results shall not be averaged, but be re-tested.
4.1.2 Unless otherwise specified, analytically pure reagents shall be used for the purpose of this document.
4.1.3 Unless otherwise specified, the water used in the tests in this document shall meet the requirements of Class-II water defined in GB/T 6682.
4.1.4 The term "room temperature” used in this document refers to 10℃~30℃.
4.1.5 The term "accurately weigh" in this document refers to the weighing to the accuracy of 0.1mg.
4.1.6 The term "accurately measure" in this document refers to measure with a pipette with an accuracy specified by corresponding national standards.
4.1.7 Constant weight in the gravimetric method refers to that mass difference of test sample after two continuous ignition or drying shall not exceed 0.3mg.
4.1.8 Unless otherwise specified, borate glass vessels shall be adopted for the purpose of this document.
4.1.9 Most of the analytical methods presented in this document are non-specific analytical methods, which can be used for preliminary assessment of chemical hazards of medical devices. However, if there is a situation that does not meet the preliminary expectations in the specific test, it does not mean that the actual risk is unacceptable, so it is necessary to adopt specific analysis methods to identify and evaluate its safety.
4.2 Preparation for test solution
Foreword i
Introduction iii
1 Scope
2 Normative references
3 Terms and definitions
4 General
5 Analysis methods for dissolved matter of test solution
6 Method for analyzing the total content of heavy metal in materials
7 Method for analyzing the content of some heavy metal elements in materials
8 Residue on ignition
9 Measurement of ethylene oxide residues - Gas chromatography
Bibliography
