Language:
    • Available Formats
    • Options
    • Availability
    • Priced From ( in USD )
    • Printed Edition
    • Ships in 1-2 business days
    • $60.00
    • Add to Cart
    • Printed Edition + PDF
    • Immediate download
    • $81.00
    • Add to Cart

Customers Who Bought This Also Bought

 

About This Item

 

Full Description

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.

 

Document History

  1. ASTM F1904-23


    Standard Guide for Testing the Biological Responses to Medical Device Particulate Debris and Degradation Products <emph type="ital">in vivo</emph>

    • Most Recent
  2. ASTM F1904-14

    👀currently
    viewing


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

    • Historical Version
  3. ASTM F1904-98(2008)


    Standard Practice for Testing the Biological Responses to Particles in vivo

    • Historical Version
  4. ASTM F1904-98(2003)


    Standard Practice for Testing the Biological Responses to Particles In Vivo

    • Historical Version
  5. ASTM F1904-98e1


    Standard Practice for Testing the Biological Responses to Particles In Vivo

    • Historical Version