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ASTM F 1904 : 2014

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Standard Practice for Testing the Biological Responses to Particles in vivo
Available format(s)

Hardcopy , PDF

Superseded date

24-04-2023

Language(s)

English

Published date

22-05-2014

1.1This 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 (*).

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

1.3This 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.

Committee
F 04
DocumentType
Standard Practice
Pages
3
PublisherName
American Society for Testing and Materials
Status
Superseded
SupersededBy
Supersedes

ASTM F 2347 : 2015 Standard Guide for Characterization and Testing of Hyaluronan as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications
ASTM F 3089 : 2014 Standard Guide for Characterization and Standardization of Polymerizable Collagen-Based Products and Associated Collagen-Cell Interactions
ASTM F 2901 : 2019 Standard Guide for Selecting Tests to Evaluate Potential Neurotoxicity of Medical Devices
ASTM F 2064 : 2017 Standard Guide for Characterization and Testing of Alginates as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications
ASTM F 748 : 2016 Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
ASTM F 2315 : 2018 Standard Guide for Immobilization or Encapsulation of Living Cells or Tissue in Alginate Gels
ASTM F 1983 : 2014 Standard Practice for Assessment of Selected Tissue Effects of Absorbable Biomaterials for Implant Applications
ASTM F 2212 : 2011 Standard Guide for Characterization of Type I Collagen as Starting Material for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPs)
ASTM F 2212 : 2020 Standard Guide for Characterization of Type I Collagen as Starting Material for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPs)
ASTM F 3089 : 2023 Standard Guide for Characterization and Standardization of Polymerizable Collagen-Based Products and Associated Collagen-Cell Interactions
ASTM F 2103 : 2018 Standard Guide for Characterization and Testing of Chitosan Salts as Starting Materials Intended for Use in Biomedical and Tissue-Engineered Medical Product Applications

ASTM F 1877 : 2005 Standard Practice for Characterization of Particles
ASTM F 1877 : 2016 Standard Practice for Characterization of Particles
ASTM F 1877 : 1998 Standard Practice for Characterization of Particles
ASTM F 1877 : 2005 : R2010 Standard Practice for Characterization of Particles
ASTM F 1877 : 2005 : EDT 1 Standard Practice for Characterization of Particles

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