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ASTM F1904-98e1

Historical Revision

Standard Practice for Testing the Biological Responses to Particles <emph type="bdit" >in vivo</emph>

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1.1 This practice covers the production of wear debris and degradation products from implanted materials that may lead to a cascade of biological responses resulting in damage to adjacent and remove tissues. In order to ascertain the role of particles in stimulating such responses, the nature of the responses, and the consequences of the responses, established protocols are needed. This is an emerging, rapidly developing area and the information gained from standard protocols is necessary to interpret responses. Some of the procedures listed here may, on further testing, not prove to be predictive of clinical responses to particulate debris. However, only the use of standard protocols will establish which are useful techniques. Since there are many possible and established ways of determining responses, a single standard protocol is not stated. However, this recommended practice indicates which necessary information should be supplied with the test results. For laboratories without established protocols, recommendations are given and indicated with an asterisk.

1.2 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.


SDO ASTM: ASTM International
Document Number F1904
Publication Date Jan. 14, 2000
Language en - English
Page Count 3
Revision Level 98e1
Supercedes
Committee F04.16
Publish Date Document Id Type View
April 1, 2023 F1904-23 Revision
March 1, 2014 F1904-14 Revision
Jan. 14, 2000 F1904-98E01 Revision
Aug. 1, 2008 F1904-98R08 Reaffirmation
Nov. 1, 2003 F1904-98R03 Reaffirmation