ASTM F1904-98e1
Historical Standard: ASTM F1904-98e1 Standard Practice for Testing the Biological Responses to Particles In Vivo
SUPERSEDED (see Active link, below)
ASTM F1904
1. 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.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
ASTM Standards
F561 Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and Fluids
F619 Practice for Extraction of Medical Plastics
F748 Practice for Selecting Generic Biological Test Methods for Materials and Devices
F1877 Practice for Characterization of Particles
Keywords
biocompatibility; biological response; in vivo; interleukins; particles; Biocompatibility; Degradation--surgical devices/applications; Growth factors; Interleukins; Macrophages; Particle analysis--medical/surgical applications; Surgical implants; Testing methods--surgical implants; in vivo Evaluation; Wear testing--surgical implant materials/applications;
ICS Code
ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)
DOI: 10.1520/F1904-98E01
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