The new version of GB/T 14233.1 was released
Recently, GB/T 14233.1-2022 “Medical Infusion, Blood Transfusion, and Injection Equipment Test Methods Part 1: Chemical Analysis Methods” (hereinafter referred to as “the new version of GB/T 14233.1”) was released and will be officially implemented on November 1, 2023. GB/T 14233.1 is one of the series of standards for the inspection methods of medical infusion, blood transfusion, and injection equipment. It mainly stipulates that the relevant chemical analysis methods include the preparation of inspection liquids, conventional leachables test methods. And analysis methods for heavy metal elements in materials, ethylene oxide Alkanes residue test method, etc.
Introduction
With the development of testing technology, the test methods specified in GB/T 14233.1-2008 may restrict the application of more advanced analytical techniques in product testing. Combined with the update of current chemical characterization analysis methods and concepts, the new version of GB/T 14233.1 has updated and integrated relevant inspection methods for common leachable items in product standards for medical infusion, blood transfusion, and injection equipment.
Revision Notes on Main Technical Contents
Compared with GB/T 14233.1-2008,the following points are mainly revised of the new version in terms of technical content.
(1) The new version of GB/T 14233.1 adds relevant descriptions about the analysis of unknowns in the “General Principles” section – “The analysis methods given in this document are mostly non-specific analysis methods. These methods can be used for the preliminary evaluation of the chemical properties of medical devices. However, if there is a situation that does not meet the preliminary expectations in a specific test, it does not mean that the actual risk is unacceptable. And specific analysis methods must be used to identify and evaluate its safety.”
With the release of ISO 10993.18:2020, the development of the revision of GB/T 16886.18, and the release of relevant guidelines for the study of leachable substances, the importance, scientificity and feasibility of unknown substance identification in the chemical characterization process of medical device materials are also becoming more and more important. It gradually becomes apparent that the new content here increases the relevance of GB/T 14233.1 and GB/T 16886.18, and further improves the referenceability of this standard.
(2) In the two parts of “Partial Heavy Metal Elements” and “Analysis Method of Partial Heavy Metal Element Content in Materials”, the “colorimetric analysis method” with poor specificity was deleted, and the “colorimetric analysis method” that can accurately quantify each element was added. Analytical “Inductively Coupled Plasma Optical Emission Spectrometry and Inductively Coupled Plasma Mass Spectrometry”.
(3) In “Determination of residual ethylene oxide”, delete “colorimetric analysis method”, add recommended chromatographic conditions in gas chromatography, and explain in this part that “other confirmed analysis methods can also be used. Such as mass spectrometry”, to ensure the flexibility of method selection and product applicability in the test of ethylene oxide residues. In addition, in the calculation of the relative content of ethylene oxide, the new version of GB/T 14233.1 also adds the expression method of “micrograms per square centimeter”. In this revision of the standard, each drafting unit focused on the verification of the newly added analytical method and the analysis of specific cases, and proved the scientificity and feasibility of the newly added analytical method and the reliability of the description of the specific analytical method.
This standard is based on the current technical level, and on the basis of citing the latest version of relevant standards, it lists simple, feasible, and highly operable test methods for different inspection items, and provides effective information for related parties of medical infusion, blood transfusion, and injection equipment products. It also provides a framework for the development of safety evaluation technology for medical products in the future. The application of the new version of the standard will promote the improvement of the relevant standard system, help to effectively check the safety of medical infusion, blood transfusion, and injection equipment products, promote the quality improvement of such products, and promote the overall healthy development of China’s medical product industry.