美国材料与试验协会标准介绍及对我国药包材团体标准工作的启示

Introduction of the Standards of American Society for Testing and Materials and Insights of Group Standards for Pharmaceutical Packaging in China

目的通过分析美国材料与试验协会(ASTM)标准概况,为我国药包材团体标准的建立和完善提供有益的参考和借鉴。方法采用文献研究与个案研究法,分析概述了ASTM标准体系,重点介绍ASTM的工作原则、标准分类、工作特点以及ASTM标准被美国其他标准所引用的情况,梳理与药包材相关的标准情况和特点。结果ASTM标准数量非常庞大,专业范围很广,是典型的以市场为驱动的标准,具有较强的技术权威性,不仅被全球工业界纷纷采用,许多标准被采用至法律法规中成为强制性标准。结论ASTM标准是团体标准典范,虽然涉及药包材的标准数量不多,但是其发展历程及其标准化工作的特点对我国药包材团体标准的发展具有重要的借鉴意义。

Objective To analyze the situation of standards by the American Society for Testing and Materials(ASTM)to provide a reference and guidance for establishment and improvement of the system of group standards for pharmaceutical packaging in China.Methods This paper uses literature research and case studies to analyze and outline the ASTM standards system through literature and case studies.Focusing on its working principles and characteristics,standards classification,and the citation of ASTM standards by other U.S standards,trying to sort out the situation and characteristics of standards related to pharmaceutical packaging.Results ASTM standards have a large of numbers and wide range of specialties.It is a typical market driven standard which has strong technical authority.ASTM standards not only have been adopted by global industries,but also many standards have been adopted in law and regulation as mandatory standards.Conclusion ASTM standards are the model of group standards.Although there are only a few standards related to pharmaceutical packaging,the development process and standardization characteristics have important reference significance for the development of group standards for pharmaceutical packaging products in China.