Norm

ASTM F1027-86(2012)

Standard Practice for Assessment of Tissue and Cell Compatibility of Orofacial Prosthetic Materials and Devices

61,51

Over deze norm

Status Definitief
Aantal pagina's 11
Commissie F04.16
Gepubliceerd op 01-10-2012
Taal Engels

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 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

1.6 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.

Details

ICS-code 11.040.40
Nederlandse titel Standard Practice for Assessment of Tissue and Cell Compatibility of Orofacial Prosthetic Materials and Devices
Engelse titel Standard Practice for Assessment of Tissue and Cell Compatibility of Orofacial Prosthetic Materials and Devices

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