5.1 This practice is useful for assessing the cytotoxic potential both when evaluating new materials or formulations for possible use in medical applications, and as part of a quality control program for established medical devices.5.2 This practice is used for assessing the cytotoxic potential of materials intended for the fabrication of inserts or implants in the orofacial region.5.3 This practice is restricted to normal non-transformed, human orofacial tissues using cells cultured in human serum factors and does not depend upon cells and serum from non-human sources.5.4 This practice incorporates procedures to monitor the quality of ingredient materials and the uniformity of the production process for formulating stock compositions.5.5 This practice may be useful to determine the effects of age and radiation, and the state of carcinogenicity on the sensitivity of HED tissues to materials and devices used for orofacial prostheses.1.1 This practice describes a procedure to assess the cytotoxic potential of materials for use in the construction of medical materials and devices using human excised donor (HED) tissues and their derived primary cells taken from the orofacial region.1.2 This practice may be used either directly to evaluate materials or as a reference against which other cytotoxicity methods may be compared.1.3 This practice is one of a series of reference methods for assessment of cytotoxic potential, employing different techniques.1.4 Assessment of cytotoxicity is one of several procedures employed in determining the biological response to a material, as recommended in Practice F748.1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
4.1 When this test method is used to measure the threshold impact sensitivity of a material, a relative sensitivity assessment is obtained which permits the ranking of materials.4.2 This test method may also be used for acceptance-testing materials for use in liquid oxygen systems. Twenty separate samples of the material submerged in liquid oxygen are subjected to 98 J (72 ft·lbf) or as specified. Impact energy delivered through a 12.7-mm (1/2-in.) diameter contact. More than one indication of sensitivity is cause for immediate rejection. A single explosion, flash, or other indication of sensitivity during the initial series of 20 tests requires that an additional 40 samples be tested without incident to ensure acceptability of the material.4.3 The threshold values are determined by this test method at ambient pressure. The sensitivity of materials to mechanical impact is known to increase with increasing pressure. Since most liquid oxygen systems operate at pressures above ambient condition, some consideration should be given to increased sensitivity and reactivity of materials at higher pressure when selecting materials for use in pressurized system.1.1 This method2,3,4 covers the determination of compatibility and relative sensitivity of materials with liquid oxygen under impact energy using the Army Ballistic Missile Agency (ABMA)-type impact tester. Materials that are impact-sensitive with liquid oxygen are generally also sensitive to reaction by other forms of energy in the presence of oxygen.1.2 This standard should be used to measure and describe the properties of materials, products, or assemblies in response to heat and flame under controlled laboratory conditions and should not be used to describe or appraise the fire hazard or fire risk of materials, products, or assemblies under actual fire conditions. However, results of this test may be used as elements of a fire risk assessment which takes into account all of the factors which are pertinent to an assessment of the fire hazard of a particular end use.1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.