ASTM International - ASTM F1904-98(2003)

Standard Practice for Testing the Biological Responses to Particles In Vivo

historical
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Organization: ASTM International
Publication Date: 1 November 2003
Status: historical
Page Count: 3
ICS Code (Implants for surgery, prosthetics and orthotics): 11.040.40
significance And Use:

This practice is to be used to help assess the biocompatibility of materials used in medical devices. It is designed to test the effect of particles from the materials on the host... View More

scope:

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.

Document History

March 1, 2014
Standard Practice for Testing the Biological Responses to Particles in vivo
1.1 This practice covers the production of wear particles and degradation products from implanted materials that may lead to a cascade of biological responses resulting in damage to adjacent and...
August 1, 2008
Standard Practice for Testing the Biological Responses to Particles in vivo
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 remote...
ASTM F1904-98(2003)
November 1, 2003
Standard Practice for Testing the Biological Responses to Particles In Vivo
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...
January 14, 2000
Standard Practice for Testing the Biological Responses to Particles In Vivo
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...
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