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ASTM F1408-97

Historical Revision

Standard Practice for Subcutaneous Screening Test for Implant Materials

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1.1 This practice provides a short-term testing method to screen the subcutaneous tissue reaction to metallic or other implant candidate materials in small laboratory animals. The material may be dense or porous. The tissue reactions will be evaluated in comparison to those evoked by control materials that are accepted as clinical implant materials.

1.2 This practice, along with other appropriate biological tests (including other ASTM test methods) may be used to assess the biocompatibility of candidate materials for use in the fabrication of devices for clinical application. It may be also applied to evaluate the effect of special surface textures and preparations of known materials.

1.3 This experimental protocol is not designed to provide a comprehensive assessment of the systemic toxicity, carcinogenicity, teratogenicity, or mutagenicity of the material.

1.4 The values stated in SI units are to be regarded as the standard.

1.5 This standard does not purport to address all of the safety problems, 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.


SDO ASTM: ASTM International
Document Number F1408
Publication Date Nov. 10, 1997
Language en - English
Page Count 4
Revision Level 97
Supercedes
Committee F04.16
Publish Date Document Id Type View
Aug. 1, 2020 F1408-20A Revision
June 1, 2020 F1408-20 Revision
Nov. 10, 1997 F1408-97 Revision
Oct. 1, 2013 F1408-97R13 Reaffirmation
May 1, 2008 F1408-97R08 Reaffirmation
Nov. 10, 1997 F1408-97R02E01 Reaffirmation