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  • ASTM
    F1904-14 Standard Practice for Testing the Biological Responses to Particles in vivo
    Edition: 2014
    $144.00
    Unlimited Users per year

Description of ASTM-F1904 2014

ASTM F1904-14

Historical Standard: Standard Practice for Testing the Biological Responses to Particles in vivo




ASTM F1904

Scope

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 remote 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 test results. For laboratories without established protocols, recommendations are given and indicated with an asterisk (*).

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

1.3 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.


Keywords

biocompatibility; biological response; in vivo; interleukins; particles


ICS Code

ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)


DOI: 10.1520/F1904-14



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About ASTM

ASTM International, formerly known as the American Society for Testing and Materials (ASTM), is a globally recognized leader in the development and delivery of international voluntary consensus standards. Today, some 12,000 ASTM standards are used around the world to improve product quality, enhance safety, facilitate market access and trade, and build consumer confidence. ASTM’s leadership in international standards development is driven by the contributions of its members: more than 30,000 of the world’s top technical experts and business professionals representing 150 countries. Working in an open and transparent process and using ASTM’s advanced electronic infrastructure, ASTM members deliver the test methods, specifications, guides, and practices that support industries and governments worldwide.
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