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ASTM F 1877 : 2005 : R2010

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 Characterization of Particles
Available format(s)

Hardcopy , PDF

Superseded date

11-11-2014

Language(s)

English

Published date

01-06-2010

1.1 This practice covers a series of procedures for characterization of the morphology, number, size, and size distribution of particles. The methods utilized include sieves, optical, SEM, and electrooptical.

1.2 These methods are appropriate for particles produced by a number of different methods. These include wear test machines (Test Method F732), total joint simulation systems (Guides F1714 and F1715), abrasion testing, methods for producing particulates, such as shatter boxes or pulverizors, commercially available particles, and particles harvested from tissues in animal or clinical studies.

1.3 The debris may include metallic, polymeric, ceramic, or any combination of these.

1.4 The digestion procedures to be used and issues of sterilization of retrieved particles are not the subject of this practice.

1.5 A classification scheme for description of particle morphology is included in Appendix X3.

1.6 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

1.7 As a precautionary measure, removed debris from implant tissues should be sterilized or minimally disinfected by an appropriate means that does not adversely affect the particulate material. 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.

Committee
F 04
DocumentType
Standard Practice
Pages
15
ProductNote
Reconfirmed 2010
PublisherName
American Society for Testing and Materials
Status
Superseded
SupersededBy
Supersedes

ASTM F 748 : 2016 Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
ASTM E 2490 : 2009 : R2015 Standard Guide for Measurement of Particle Size Distribution of Nanomaterials in Suspension by Photon Correlation Spectroscopy (PCS)
ASTM E 2526 : 2008 : R2013 Standard Test Method for Evaluation of Cytotoxicity of Nanoparticulate Materials in Porcine Kidney Cells and Human Hepatocarcinoma Cells (Withdrawn 2022)
ASTM F 2603 : 2006 : R2012 Standard Guide for Interpreting Images of Polymeric Tissue Scaffolds
ASTM F 2027 : 2016 Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products
ASTM F 2847 : 2017 Standard Practice for Reporting and Assessment of Residues on Single-Use Implants and Single-Use Sterile Instruments
ASTM E 2524 : 2008 : R2013 Standard Test Method for Analysis of Hemolytic Properties of Nanoparticles (Withdrawn 2022)
ASTM F 2694 : 2016 Standard Practice for Functional and Wear Evaluation of Motion-Preserving Lumbar Total Facet Prostheses
ASTM F 3295 : 2018 Standard Guide for Impingement Testing of Total Disc Prostheses
ASTM F 3018 : 2017 Standard Guide for Assessment of Hard-on-Hard Articulation Total Hip Replacement and Hip Resurfacing Arthroplasty Devices
ASTM F 1904 : 2014 Standard Practice for Testing the Biological Responses to Particles <emph type="bdit" >in vivo</emph>
ASTM F 3047M : 2015 Standard Guide for High Demand Hip Simulator Wear Testing of Hard-on-hard Articulations
ASTM F 561 : 2019 Standard Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and Fluids
ASTM F 2423 : 2011 : R2016 Standard Guide for Functional, Kinematic, and Wear Assessment of Total Disc Prostheses
ASTM F 2789 : 2010 : R2015 Standard Guide for Mechanical and Functional Characterization of Nucleus Devices
ASTM F 2624 : 2012 : R2016 Standard Test Method for Static, Dynamic, and Wear Assessment of Extra-Discal Single Level Spinal Constructs

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