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Significance and Use
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.
5.5 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.
1.4 Assessment of cytotoxicity is one of several procedures employed in determining the biological response to a material, as recommended in Practice F748.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
D883 Terminology Relating to Plastics
F604 Specification for Silicone Elastomers Used in Medical Applications
F703 Specification for Implantable Breast Prostheses
F748 Practice for Selecting Generic Biological Test Methods for Materials and Devices
F813 Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices
ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)