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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.
Formerly under the jurisdiction of Committee F04 on Medical and Surgical Materials and Devices, this terminology was withdrawn in January 2012 in accordance with section 10.5.3.1 of the Regulations Governing ASTM Technical Committees, which requires that standards shall be updated by the end of the eighth year since the last approval date.
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.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
D638 Test Method for Tensile Properties of Plastics
D747 Test Method for Apparent Bending Modulus of Plastics by Means of a Cantilever Beam
D790 Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials
D882 Test Methods for Tensile Properties of Thin Plastic Sheeting
D1003 Test Method for Haze and Luminous Transmittance of Transparent Plastics