1.1本术语涵盖医疗和外科设备中的聚合物生物材料。术语定义为与医疗和外科材料和设备相关的术语。不包括在其他现成参考文献中普遍理解和常用或充分定义的术语，除非对生物材料的特定描述可能更明确。 1.2因此，本术语旨在选择性地使用材料科学和技术中普遍使用的术语，并在许多文件中发布，如以下章节中列出的文件。 该列表还旨在定义在其他ASTM标准中显著出现而在其他地方未出现的术语。 1.3这些定义基本上与其他ASTM金属、陶瓷和玻璃、橡胶和聚合物等标准中发布的定义相同，或由其他标准编写组织发布的定义相同，如国际标准化组织（ISO）、美国机械工程师学会（AIME）、美国整形和重建外科医生学会（ASPR），和组织培养协会（TCA）。 1.4需要使用该术语来补充当前关于材料术语的文件。该术语涵盖以下各学科:塑料（聚合物）、橡胶（弹性体）和纺织品（聚合物衍生）。 1.5越来越多的产品（聚合物、冶金和陶瓷类型）名称以及化学、物理、机械和分析测试和标准的名称在医疗和外科设备及临床服务中的生物材料的文献和商业中得到普遍使用。 第节列出了本术语中引用的文件。 1.6表1列出了缩写的anagramic名称。附录A1是与生物材料相关的通用术语词典。

1.1 This terminology covers polymeric biomaterials in medical and surgical devices. Terms are defined as they are used relative to medical and surgical materials and devices. Terms that are generally understood and in common usage or adequately defined in other readily available references are not included except where particular delineation to biomaterials may be more clearly stated. 1.2 This terminology is therefore intended to be selective of terms used generally in materials science and technology and published in a number of documents, such as those listed in the succeeding sections. The listing is also intended to define terms that appear prominently within other ASTM standards and do not appear elsewhere. 1.3 The definitions are substantially identical to those published in other ASTM standards on metals, ceramics and glass, rubbers and polymers, and so forth, or published by other standards writing organizations, such as International Standards Organization (ISO), American Institute of Mechanical Engineers (AIME), American Society of Plastic and Reconstructive Surgeons (ASPR), and Tissue Culture Association (TCA). 1.4 A need exists for this terminology to supplement current documents on terminology which concentrate on materials. This terminology covers each of the following disciplines: plastics (polymers), rubber (elastomers), and textiles (polymer derived). 1.5 An increasing number of product (polymeric, metallurgical, and ceramic types) designations and designations for chemical, physical, mechanical, and analytical tests and standards are coming into common usage in the literature and commerce of biomaterials in medical and surgical devices and clinical services. Section lists those documents referenced in this terminology. 1.6 Table 1 lists abbreviated, anagramic designations. Annex A1 is a thesaurus of general usage terms relating to biomaterials.