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, etc., 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 2 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.