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ASTM F 1877 : 2016

Current

Current

The latest, up-to-date edition.

Standard Practice for Characterization of Particles

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-10-2016

€74.48
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This practice covers a series of procedures for characterization of the morphology, number, size, and size distribution of particles.

Committee
F 04
DocumentType
Standard Practice
Pages
15
PublisherName
American Society for Testing and Materials
Status
Current
Supersedes

1.1This practice covers a series of procedures for characterization of the morphology, number, size, and size distribution of particles. The methods utilized include sieves, optical, scanning electron microscopy (SEM), transmission electron microscopy (TEM), and electrooptical.

1.2These 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 pulverizers, commercially available particles, and particles harvested from tissues in animal or clinical studies.

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

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

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

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

1.7As 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.

1.8This 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.

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 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 2694 : 2016 Standard Practice for Functional and Wear Evaluation of Motion-Preserving Lumbar Total Facet Prostheses
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 F 2624 : 2012 : R2016 Standard Test Method for Static, Dynamic, and Wear Assessment of Extra-Discal Single Level Spinal Constructs
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 2524 : 2008 : R2013 Standard Test Method for Analysis of Hemolytic Properties of Nanoparticles (Withdrawn 2022)
ASTM F 1903 : 2018 Standard Practice for Testing for Cellular Responses to Particles <emph type="bdit" >in vitro</emph>
ASTM E 3351 : 2022 Standard Test Method for Detection of Nitric Oxide Production <emph type="bdit">In Vitro</emph >
ASTM F 3047M : 2023 Standard Guide for High Demand Hip Simulator Wear Testing of Hard-on-Hard Articulations
ASTM F 2789 : 2010 : R2020 Standard Guide for Mechanical and Functional Characterization of Nucleus Devices
ASTM F 2665 : 2021 Standard Specification for Total Ankle Replacement Prosthesis
ASTM F 2603 : 2006 : R2020 Standard Guide for Interpreting Images of Polymeric Tissue Scaffolds
ASTM E 2490 : 2009 : R2021 Standard Guide for Measurement of Particle Size Distribution of Nanomaterials in Suspension by Photon Correlation Spectroscopy (PCS)
ASTM E 2524 : 2022 Standard Test Method for Analysis of Hemolytic Properties of Nanoparticles
ASTM F 2624 : 2012 : R2020 Standard Test Method for Static, Dynamic, and Wear Assessment of Extra-Discal Single Level Spinal Constructs
ASTM F 1904 : 2023 Standard Guide for Testing the Biological Responses to Medical Device Particulate Debris and Degradation Products <emph type="ital">in vivo</emph>
ASTM F 3335 : 2020 Standard Guide for Assessing the Removal of Additive Manufacturing Residues in Medical Devices Fabricated by Powder Bed Fusion
ASTM F 2694 : 2016 : R2020 Standard Practice for Functional and Wear Evaluation of Motion-Preserving Lumbar Total Facet Prostheses
ASTM F 2423 : 2011 : R2020 Standard Guide for Functional, Kinematic, and Wear Assessment of Total Disc Prostheses
ASTM E 2526 : 2022 Standard Test Method for Evaluation of Cytotoxicity of Nanoparticulate Materials in Porcine Kidney Cells and Human Hepatocarcinoma Cells
ASTM E 3238 : 2020 Standard Test Method for Quantitative Measurement of the Chemoattractant Capacity of a Nanoparticulate Material <emph type="bdit">in vitro</emph>

ASTM E 11 : 2020 Standard Specification for Woven Wire Test Sieve Cloth and Test Sieves
ASTM E 1617 : 2009 : R2024 Standard Practice for Reporting Particle Size Characterization Data
ASTM F 1714 : 1996 : R2008 Standard Guide for Gravimetric Wear Assessment of Prosthetic Hip Designs in Simulator Devices
ASTM E 11 : 2024 Standard Specification for Woven Wire Test Sieve Cloth and Test Sieves
ASTM E 161 : 2017 Standard Specification for Electroformed Material and Test Sieves
ASTM F 1715 : 2000 Standard Guide for Wear Assessment of Prosthetic Knee Designs in Simulator Devices
ASTM E 1617 : 2009 : R2019 Standard Practice for Reporting Particle Size Characterization Data
ASTM E 161 : 2017 : R2021 Standard Specification for Electroformed Material and Test Sieves
ASTM E 11 : 2022 Standard Specification for Woven Wire Test Sieve Cloth and Test Sieves
ASTM E 1617 : 2009 : R2014 : EDT 1 Standard Practice for Reporting Particle Size Characterization Data
ASTM E 1617 : 1997 : R2007 Standard Practice for Reporting Particle Size Characterization Data
ASTM F 1714 : 1996 : R2002 Standard Guide for Gravimetric Wear Assessment of Prosthetic Hip-Designs in Simulator Devices
ASTM F 1714 : 1996 : R2013 Standard Guide for Gravimetric Wear Assessment of Prosthetic Hip Designs in Simulator Devices
ASTM F 662 : 1986 : R1992 : EDT 1 Test Method for Measurement of Particle Count and Size Distribution in Batch Samples for Filter Evaluation Using an Electrical Resistance Particle Counter (Withdrawn 2001)
ASTM C 242 : 2020 : REV B Standard Terminology of Ceramic Whitewares and Related Products
ASTM C 242 : 2021 Standard Terminology of Ceramic Whitewares and Related Products
ASTM F 1714 : 1996 : R2018 Standard Guide for Gravimetric Wear Assessment of Prosthetic Hip Designs in Simulator Devices
ASTM E 1617 : 2009 Standard Practice for Reporting Particle Size Characterization Data
ASTM E 1617 : 1997 : R2002 Standard Practice for Reporting Particle Size Characterization Data
ASTM E 766 : 1998 Standard Practice for Calibrating the Magnification of a Scanning Electron Microscope
ASTM F 1714 : 1996 Standard Guide for Gravimetric Wear Assessment of Prosthetic Hip-Designs in Simulator Devices
ASTM C 678 : 1975 : R1991 : EDT 1 Test Method for Determination of Particle Size Distribution of Alumina or Quartz Using Centrifugal Sedimentation
ASTM F 661 : 1992 Practice for Particle Count and Size Distribution Measurement in Batch Samples for Filter Evaluation Using an Optical Particle Counter (Withdrawn 2001)
ASTM E 1617 : 1997 Standard Practice for Reporting Particle Size Characterization Data

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