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Scope

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.

Keywords

alpha growth factor (AGF); orofacial prosthetic materials/devices-tissue/cell compatibility; assessment, practice, ; Biocompatibility; orofacial prosthetic materials/devices-tissue/cell compatibility; assessment, practice, ; Cell compatibility; orofacial prosthetic materials/devices-tissue/cell compatibility; assessment, practice, ; Cell culture; orofacial prosthetic materials/devices-tissue/cell compatibility; assessment, practice, ; Facial implants; orofacial prosthetic materials/devices-tissue/cell compatibility; assessment, practice, ; Human excised donor cells (HED); orofacial prosthetic materials/devices-tissue/cell compatibility; assessment, practice, ; Implants; orofacial prosthetic materials/devices-tissue/cell compatibility; assessment, practice, ; Medical devices; orofacial prosthetic materials/devices-tissue/cell compatibility; assessment, practice, ; Mouth; orofacial prosthetic materials/devices-tissue/cell; compatibilityassessment, practice, ; Oral/maxillofacial surgery; orofacial prosthetic materials/devices-tissue/cell compatibility; assessment, practice, ; Orofacial materials; orofacial prosthetic materials/devices-tissue/cellcompatibility; assessment, practice, ; Prosthesis; orofacial prosthetic materials/devices-tissue/cell compatibility; assessment, practice, ; Tissue compatibility; orofacial prosthetic materials/devices-tissue/cell compatibility; assessment, practice, ;Order Form; ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)

To find similar documents by ASTM Volume:

13.01 (Medical and Surgical Materials and Devices)

To find similar documents by classification:

11.040.40 (Implants for surgery, prosthetics and orthotics Including pacemakers Ophthalmic implants, see 11.040.70)

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