ASTM F 1877 : 2016 : REDLINE
Current
The latest, up-to-date edition.
Standard Practice for Characterization of Particles
English
01-10-2016
CONTAINED IN VOL. 13.01, 2016 Defines a series of procedures for characterization of the morphology, number, size, and size distribution of particles.
Committee |
F 04
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DocumentType |
Redline
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Pages |
17
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PublisherName |
American Society for Testing and Materials
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Status |
Current
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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.
DD ISO/TS 10993-19:2006 | Biological evaluation of medical devices Physico-chemical, morphological and topographical characterization of materials |
ISO 9276-6:2008 | Representation of results of particle size analysis — Part 6: Descriptive and quantitative representation of particle shape and morphology |
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ASTM F 1904 : 2014 : REDLINE | Standard Practice for Testing the Biological Responses to Particles <emph type="bdit" >in vivo</emph> |
ASTM E 2524 : 2008 | Standard Test Method for Analysis of Hemolytic Properties of Nanoparticles |
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02/563039 DC : DRAFT JULY 2002 | BS ISO 17853 - WEAR OF IMPLANT MATERIALS - POLYMER AND METAL WEAR PARTICLES - ISOLATION, CHARACTERIZATION AND QUANTIFICATION |
AASHTO PP 74 : 2013 | PRACTICE FOR DETERMINATION OF SIZE AND ROUNDNESS OF GLASS BEADS USED IN TRAFFIC MARKINGS BY MEANS OF COMPUTERIZED OPTICAL METHOD |
ASTM E 2524 : 2008 : R2013 | Standard Test Method for Analysis of Hemolytic Properties of Nanoparticles (Withdrawn 2022) |
ASTM F 2603 : 2006 | Standard Guide for Interpreting Images of Polymeric Tissue Scaffolds |
ASTM E 2526 : 2008 | Standard Test Method for Evaluation of Cytotoxicity of Nanoparticulate Materials in Porcine Kidney Cells and Human Hepatocarcinoma Cells |
ASTM F 2423 : 2011 | Standard Guide for Functional, Kinematic, and Wear Assessment of Total Disc 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 561 : 2013 | Standard Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and Fluids |
BS ISO 9276-6:2008 | Representation of results of particle size analysis Descriptive and quantitative representation of particle shape and morphology |
08/30174997 DC : DRAFT DEC 2008 | BS ISO 17853 - WEAR OF IMPLANT MATERIALS - POLYMER AND METAL WEAR PARTICLES - ISOLATION, CHARACTERIZATION AND QUANTIFICATION |
ANSI/AAMI/ISO TIR10993-19:2006 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 19: PHYSICOCHEMICAL, MORPHOLOGICAL, AND TOPOGRAPHICAL CHARACTERIZATION OF MATERIALS |
ASTM F 3018 : 2017 | Standard Guide for Assessment of Hard-on-Hard Articulation Total Hip Replacement and Hip Resurfacing Arthroplasty Devices |
ASTM F 2603 : 2006 : R2012 | Standard Guide for Interpreting Images of Polymeric Tissue Scaffolds |
ASTM F 2624 : 2012 | Standard Test Method for Static, Dynamic, and Wear Assessment of Extra-Discal Single Level Spinal Constructs |
ISO 17853:2011 | Wear of implant materials Polymer and metal wear particles Isolation and characterization |
BS ISO 17853:2011 | Wear of implant materials. Polymer and metal wear particles. Isolation and characterization |
ASTM F 2789 : 201 | Standard Guide for Mechanical and Functional Characterization of Nucleus Devices |
AASHTO PP 74 : 2013 : R2015 | PRACTICE FOR DETERMINATION OF SIZE AND ROUNDNESS OF GLASS BEADS USED IN TRAFFIC MARKINGS BY MEANS OF COMPUTERIZED OPTICAL METHOD |
DIN ISO 9276-6:2012-01 | Representation of results of particle size analysis - Part 6: Descriptive and quantitative representation of particle shape and morphology (ISO 9276-6:2008) |
ASTM F 3047M : 2015 | Standard Guide for High Demand Hip Simulator Wear Testing of Hard-on-hard Articulations |
ASTM E 2490:2009 | Standard Guide for Measurement of Particle Size Distribution of Nanomaterials in Suspension by Photon Correlation Spectroscopy (PCS) |
ISO/TS 10993-19:2006 | Biological evaluation of medical devices Part 19: Physico-chemical, morphological and topographical characterization of materials |
ASTM F 2789 : 2010 : R2015 | Standard Guide for Mechanical and Functional Characterization of Nucleus Devices |
ASTM F 2423 : 2011 : R2016 | Standard Guide for Functional, Kinematic, and Wear Assessment of Total Disc Prostheses |
ASTM F 748 : 2016 : REDLINE | Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices |
ASTM F 2847 : 2017 : REDLINE | Standard Practice for Reporting and Assessment of Residues on Single-Use Implants and Single-Use Sterile Instruments |
ASTM F 561 : 2013 | Standard Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and Fluids |
ASTM F 1715 : 2000 | Standard Guide for Wear Assessment of Prosthetic Knee Designs in Simulator Devices |
ASTM F 732 : 2017 : REDLINE | Standard Test Method for Wear Testing of Polymeric Materials Used in Total Joint Prostheses |
ASTM F 662 : 1986 | METHOD FOR MEASUREMENT OF PARTICLE COUNT AND SIZE DISTRIBUTION IN BATCH SAMPLES FOR FILTER EVALUATION USING AN ELECTRICAL RESISTANCE PARTICLE COUNTER |
ASTM F 660 : 1983 : R2002 : EDT 1 | Standard Practice for Comparing Particle Size in the Use of Alternative Types of Particle Counters |
ASTM E 11 : 2017 : REDLINE | Standard Specification for Woven Wire Test Sieve Cloth and Test Sieves |
ASTM C 678 : 1975 | Test Method for Determination of Particle Size Distribution of Alumina or Quartz Using Centrifugal Sedimentation (Withdrawn 1995) |
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) |
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