Current Situation of International Organization for Standardization/Technical Committee 249 International Standards of Traditional Chinese Medicine

Objective： To review the current situation and progress of traditional Chinese medicine（TCM） international standards, standard projects and proposals in International Organization for Standardization（ISO）/technical committee（TC） 249. Methods： ISO/TC 249 standards and standard projects on the ISO website were searched and new standard proposals information were collected from ISO/TC 249 National Mirror Committee in China. Then all the available data were summarized in 5 closely related items, including proposed time, proposed country, assigned working group（WG）, current stage and classification. Results： In ISO/TC 249, there were 2 international standards, 18 standard projects and 24 new standard proposals proposed in 2014. These 44 standard subjects increased year by year since 2011. Twenty-nine of them were proposed by China, 15 were assigned to WG 4, 36 were in preliminary and preparatory stage and 8 were categorized into 4 fields, 7 groups and sub-groups based on International Classification Standards. Conclusion： A rapid and steady development of international standardization in TCM can be observed in ISO/TC 249.

Characterization and Comparison Analysis of WHO Monographs on Selected Medicinal Plants and Iso Standards of Chinese Materia Medica

Medicinal plants or Chinese materia medica(CMM)are now attracting worldwide attention as they have increasingly prominent advantages over chemical drugs in disease treatment and healthcare.Since the 1990s,World Health Organization(WHO)and International Organization for Standardization established the Technical Committee of Traditional Chinese Medicine(ISO/TC 249)have carried out the development of quality standards on medicinal plants or CMMs respectively,and a considerable number of monographs and international standards have been published.Since the two international organizations adhere to different principles,the standards they develop naturally have different emphasis.Driven by market demand and international trade,ISO mainly takes quality,efficacy and safety into consideration when developing standards,while WHO pays more attention to clinical practice,quality control and medication guidance.Up to now,there is a lack of comparative analysis on the records,background,principles,basic content,and main requirements of quality standards on medicinal plants or CMMs respectively published by WHO and ISO.Therefore,based on international standards of CMM developed by ISO/TC 249 platform and WHO Monographs on Selected Medicinal Plants,this paper systematically compares the purposes,selected principles,standard-developing process,basic content,and main quality requirements to summarize their similarities and differences,and find their merits,aiming to serve as a reference to the development of international standards for CMMs that helps them go global.

ISO/TC249中医药国际标准化工作进展分析及建议

国际标准化组织中医药技术委员会(简称ISO/TC249)成立已逾六年,发布3项中医药国际标准,在研标准项目30项,是ISO最年轻、最活跃的技术委员会之一。2015年6月,ISO/TC249的名称正式确定为"中医药技术委员会",至此,ISO中医药国际标准化工作迈入了新的阶段。文章介绍了ISO中医药国际标准化工作进展,对ISO中医药国际标准化工作面临的新形势进行了分析,提出了我国在ISO/TC249的工作建议,为中医药国际标准化工作提供依据。

中医药学语言系统的语义网络框架:一个面向中医药领域的规范化顶层本体

中医药学语言系统(TCMLS)旨在实现规范化、一体化的中医药术语体系,以支持中医药文献与数据资源的合理组织和有效检索。"Health informatics--Semantic network framework of traditional Chinese medicine language system[ISO/DTS 17938]"(健康信息学—中医药学语言系统的语义网络框架)是国际标准化组织(ISO)于近期完成、正在审核的技术规范草案。它作为一个面向中医药领域的规范化顶层本体,为中医药学语言系统中的所有概念提供了一体化的概念框架,对于中医药学语言系统的规范化和国际化具有重要意义。

中医药语义网络的顶层框架研究

目的:研究中医药学语义网络的顶层框架。为建立规范化的中医药术语体系,以支持中医药信息资源的合理组织和有效检索服务。方法:通过构建中医药学语言系统,以"概念"为核心对中医药术语进行系统梳理,建立概念层次结构,并表达概念间的复杂关系。结果:最终形成的中医药语义网络顶层框架包括96种语义类型和58种语义关系。结论:该框架为中医药术语系统的规范化加工和处理提供了依据,将在中医药术语系统的质量保证和国际推广工作中发挥关键作用。

中医药文献元数据标准化研究进展

目前在国际上尚缺乏一部面向中医药领域的文献元数据技术规范,这不利于中医药文献的标引和检索。"ISO/DTS17948 Traditional Chinese medicine literature metadata(中医药文献元数据)"是国际标准化组织(ISO)于近期完成、正在审核的技术规范草案。它反映了中医药文献的特点,对于中医药文献资源的系统保护和深度利用具有重要意义。阐述该技术规范草案的内容和特点,对其与相关元数据标准进行比较分析。

关于ISO/TC 249中医药国际标准可视化探析

目的 本研究对国际标准化组织/中医药技术委员会(ISO/TC 249)制定的标准现状及进展进行回顾,探讨中医药领域标准制定的项目策略,有利于中医药领域的对外经贸和交流合作。方法 通过ISO官网获取ISO/TC 249有关的标准数据,主要涵盖标准的名称、提案时间、当前所处阶段、标准实施范围及国际标准分类数据,作为后续分析数据源。采用Gephi描绘ISO/TC 249标准主题的共现网络图。结果 截至2022年4月30日,ISO/TC 249共有116个标准项目,其中已发布的标准有81个,正在制定的标准有35个。其中,有两个标准在发布后已完成修订,原发布标准进行撤销,未计入标准项目总数。自2014年发布第一个标准“一次性使用的无菌针灸针”以来,标准发布数量呈现逐年增加的趋势。其中,17.24%(20/116)的标准处于发布后定期审查阶段,56.03%(65/116)的标准处于发布阶段,3.45%(4/116)的标准处于审批阶段,5.17%(6/116)的标准处于咨询阶段,3.45%(4/116)的标准处于委员会审议阶段,14.66%(17/116)的标准处于准备阶段。通过国际标准分类法(ICS)分类号分析,上述标准研制集中在中药领域,占比达到49.54%。同时,网络分析数据显示,前5个最常用的词是“材料”“词根”“需求”“产品”和“系统”(去除介词、连词和代词等噪声数据)。此外,“系统”与“计算机化”“编码”“图像”“语言”和“分析”共同出现;“要求”与“制造”“煎剂”“工艺”和“材料”共同出现;“设备”与“脉冲”“电”“皮肤”和“测量”共同出现。结论 随着问题的多样化和复杂化的发展,标准的制定也面向多学科领域,这也是培养交叉学科人才,特别是复方中药国际标准化人才的原因。多角度分析、制定和论证标准,符合不同学科的行业需求,能增强标准的可得性和行业的服务能力。