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ASTM F1877-05(2010)

(Practice)

Standard Practice for Characterization of Particles

Standard Practice for Characterization of Particles

SIGNIFICANCE AND USE
The biological response to materials in the form of small particles, as from wear debris, often is significantly different from that to the same materials as larger implant components. The size and shape (morphology) of the particles may have a major effect on the biological response; therefore, this practice provides a standardized nomenclature for describing particles. Such a unified nomenclature will be of value in interpretation of biological tests of responses to particles, in that it will facilitate separation of biological responses associated with shape from those associated with the chemical composition of debris.
The quantity, size, and morphology of particles released as wear debris from implants in vivo may produce an adverse biological response which will affect the long term survival of the device. Characterization of such debris will provide valuable information regarding the effectiveness of device designs or methods of processing components and the mechanisms of wear.
The morphology of particles produced in laboratory tests of wear and abrasion often is affected by the test conditions, such as the magnitude and rate of load application, device configuration, and test environment. Comparison of the morphology and size of particles produced in vitro with those produced in vivo will provide valuable information regarding the degree to which the method simulates the in vivo condition being modeled.
SCOPE
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.

General Information

Status
Historical
Publication Date
31-May-2010
ICS
19.120 - Particle size analysis. Sieving
Technical Committee
F04 - Medical and Surgical Materials and Devices
Drafting Committee
F04.16 - Biocompatibility Test Methods
Current Stage
Ref Project

Relations

Replaces
ASTM F1877-05e1 - Standard Practice for Characterization of Particles
Effective Date
01-Jun-2010
Replaced By
ASTM F1877-16 - Standard Practice for Characterization of Particles
Effective Date
01-Oct-2016
Referred By
ASTM F1903-18 - Standard Practice for Testing for Cellular Responses to Particles <emph type="bdit" >in vitro</emph>
Effective Date
01-Jun-2010
Referred By
ASTM E2526-22 - Standard Test Method for Evaluation of Cytotoxicity of Nanoparticulate Materials in Porcine Kidney Cells and Human Hepatocarcinoma Cells
Effective Date
01-Jun-2010
Referred By
ASTM E2524-22 - Standard Test Method for Analysis of Hemolytic Properties of Nanoparticles
Effective Date
01-Jun-2010
Referred By
ASTM F3018-17 - Standard Guide for Assessment of Hard-on-Hard Articulation Total Hip Replacement and Hip Resurfacing Arthroplasty Devices
Effective Date
01-Jun-2010
Referred By
ASTM F2027-16 - Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products
Effective Date
01-Jun-2010
Referred By
ASTM F2665-21 - Standard Specification for Total Ankle Replacement Prosthesis
Effective Date
01-Jun-2010
Referred By
ASTM F3295-18 - Standard Guide for Impingement Testing of Total Disc Prostheses
Effective Date
01-Jun-2010
Referred By
ASTM F2423-11(2020) - Standard Guide for Functional, Kinematic, and Wear Assessment of Total Disc Prostheses
Effective Date
01-Jun-2010
Referred By
ASTM F3047M-23 - Standard Guide for High Demand Hip Simulator Wear Testing of Hard-on-Hard Articulations
Effective Date
01-Jun-2010
Referred By
ASTM F1904-23 - Standard Guide for Testing the Biological Responses to Medical Device Particulate Debris and Degradation Products <emph type="ital">in vivo</emph>
Effective Date
01-Jun-2010
Referred By
ASTM F2789-10(2020) - Standard Guide for Mechanical and Functional Characterization of Nucleus Devices
Effective Date
01-Jun-2010
Referred By
ASTM F748-16 - Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
Effective Date
01-Jun-2010
Referred By
ASTM F2083-21 - Standard Specification for Knee Replacement Prosthesis (Withdrawn 2023)
Effective Date
01-Jun-2010

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ASTM F1877-05(2010) - Standard Practice for Characterization of Particles
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Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation: F1877 − 05(Reapproved 2010)
Standard Practice for
1
Characterization of Particles
This standard is issued under the fixed designation F1877; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope 2. Referenced Documents
2
1.1 This practice covers a series of procedures for charac- 2.1 ASTM Standards:
terization of the morphology, number, size, and size distribu- C242 Terminology of Ceramic Whitewares and Related
tion of particles. The methods utilized include sieves, optical, Products
SEM, and electrooptical. C678 Test Method for Determination of Particle Size Distri-
bution of Alumina or Quartz Using Centrifugal Sedimen-
1.2 Thesemethodsareappropriateforparticlesproducedby
3
tation (Withdrawn 1995)
a number of different methods. These include wear test
E11 Specification for Woven Wire Test Sieve Cloth and Test
machines (Test Method F732), total joint simulation systems
Sieves
(Guides F1714 and F1715), abrasion testing, methods for
E161 Specification for Precision Electroformed Sieves
producing particulates, such as shatter boxes or pulverizors,
E766 Practice for Calibrating the Magnification of a Scan-
commercially available particles, and particles harvested from
ning Electron Microscope
tissues in animal or clinical studies.
E1617 Practice for Reporting Particle Size Characterization
1.3 The debris may include metallic, polymeric, ceramic, or
Data
any combination of these.
F561 Practice for Retrieval and Analysis of Medical
Devices, and Associated Tissues and Fluids
1.4 The digestion procedures to be used and issues of
sterilization of retrieved particles are not the subject of this F660 Practice for Comparing Particle Size in the Use of
Alternative Types of Particle Counters
practice.
F661 Practice for Particle Count and Size Distribution Mea-
1.5 A classification scheme for description of particle mor-
surement in Batch Samples for Filter Evaluation Using an
phology is included in Appendix X3.
Optical Particle Counter (Discontinued 2000) (Withdrawn
3
1.6 The values stated in SI units are to be regarded as
2000)
standard. No other units of measurement are included in this
F662 Test Method for Measurement of Particle Count and
standard.
Size Distribution in Batch Samples for Filter Evaluation
1.7 As a precautionary measure, removed debris from Using an Electrical Resistance Particle Counter (Discon-
3
implanttissuesshouldbesterilizedorminimallydisinfectedby tinued 2002) (Withdrawn 2002)
an appropriate means that does not adversely affect the F732 Test Method for Wear Testing of Polymeric Materials
particulate material. This standard does not purport to address Used in Total Joint Prostheses
all of the safety concerns, if any, associated with its use. It is F1714 GuideforGravimetricWearAssessmentofProsthetic
the responsibility of the user of this standard to establish Hip Designs in Simulator Devices
appropriate safety and health practices and determine the F1715 Guide for Wear Assessment of Prosthetic Knee De-
3
applicability of regulatory limitations prior to use. signs in Simulator Devices (Withdrawn 2006)
1 2
ThispracticeisunderthejurisdictionofASTMCommitteeF04onMedicaland For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Surgical Materials and Devices and is the direct responsibility of Subcommittee contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
F04.16 on Biocompatibility Test Methods. Standards volume information, refer to the standard’s Document Summary page on
Current edition approved June 1, 2010. Published September 2010. Originally the ASTM website.
ε1 3
approved in 1998. Last previous edition approved in 2005 as F1877 – 05 . DOI: The last approved version of this historical standard is referenced on
10.1520/F1877-05R10. www.astm.org.
*A Summary of Changes section appears at the end of this standard
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F1877 − 05 (2010)
3. Terminology detailed studies, several methods are described that may be
utilized for numerically characterizing their dimensions, size
3.1 Definitions of Terms Specific to This Standard:
distribution, and number.
3.1.1 agglomerate, n—a jumbled mass or collection of two
or more particles or aggregates, or a combination thereof, held
5. Significance and Use
together by relatively weak cohesive forces caused by weak
chemical bonding or an electrostatic surface charge generated
5.1 Thebiologicalresponsetomaterialsintheformofsmall
by handling or
...

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SIGNIFICANCE AND USE
5.1 The biological response to materials in the form of small particles, as from wear debris, often is significantly different from that to the same materials as larger implant components. The size and shape (morphology) of the particles may have a major effect on the biological response; therefore, this practice provides a standardized nomenclature for describing particles. Such a unified nomenclature will be of value in interpretation of biological tests of responses to particles, in that it will facilitate separation of biological responses associated with shape from those associated with the chemical composition of debris.  
5.2 The quantity, size, and morphology of particles released as wear debris from implants in vivo may produce an adverse biological response which will affect the long term survival of the device. Characterization of such debris will provide valuable information regarding the effectiveness of device designs or methods of processing components and the mechanisms of wear.  
5.3 The morphology of particles produced in laboratory tests of wear and abrasion often is affected by the test conditions, such as the magnitude and rate of load application, device configuration, and test environment. Comparison of the morphology and size of particles produced in vitro with those produced in vivo will provide valuable information regarding the degree to which the method simulates the in vivo condition being modeled.
SCOPE
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, scanning electron microscopy (SEM), transmission electron microscopy (TEM), 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 pulverizers, 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.  
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3.1 Interpretation and use of data generated by particle characterization methods is highly dependent on the definitions of terms describing that data. It is extremely important that those terms be defined in precisely the same way both when comparing data from different characterization techniques and even when correlating data from the same technique.  
3.2 It is likewise important that users of particle characterization methods and the data generated therefrom understand the principles of the methods, so that differences and similarities in the data can be interpreted in relation to those principles. That understanding can help to avoid disagreements when data from different characterization methods are compared.  
3.3 The definitions contained in this terminology will aid in the interpretation of particle characterization data with respect to the method(s) used to produce that data.
SCOPE
1.1 This terminology covers the definitions of terms used in the description and procedures of analysis of particulate materials not ordinarily analyzed using test sieves. The terms relate directly to the equipment used in analysis, the physical forms of the materials to be analyzed, and selected descriptive data reduction and analysis formats.  
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1.3 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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ASTM D502-89(2023)(Test Method)
Standard Test Method for Particle Size of Soaps and Other Detergents

SIGNIFICANCE AND USE
3.1 This test method assures that the particle size of soaps and detergents conforms to specifications having to do with density and packaging, among others. It also offers a means of controlling the amount of potentially hazardous very low particle size material.
SCOPE
1.1 This test method covers the determination of the particle size of soaps and other detergents by hand sieving and machine sieving methods.  
1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
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ASTM D5444-23(Test Method)
Standard Test Method for Mechanical Size Analysis of Extracted Aggregate

SIGNIFICANCE AND USE
3.1 This test method is used to determine the grading of aggregates extracted from asphalt mixtures. The results are used to determine compliance of the particle size distribution with applicable specifications requirements, and to provide necessary data for control of the production of various aggregates to be used in asphalt mixtures.
Note 1: The quality of the results produced by this standard are dependent on the competence of the personnel performing the procedure and the capability, calibration, and maintenance of the equipment used. Agencies that meet the criteria of Specification D3666 are generally considered capable of competent and objective testing, sampling, inspection, etc. Users of this standard are cautioned that compliance with Specification D3666 alone does not completely ensure reliable results. Reliable results depend on many factors; following the suggestions of Specification D3666 or some similar acceptable guideline provides a means of evaluating and controlling some of those factors.
SCOPE
1.1 This test method covers a procedure for determination of the particle size distribution of fine and coarse aggregates extracted from asphalt mixtures using sieves with square openings.  
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ASTM D5158-23(Test Method)
Standard Test Method for Determination of Particle Size of Fine Mesh and Powdered Activated Carbon by Air-Jet Sieving

SIGNIFICANCE AND USE
5.1 The particle size of fine mesh and powdered activated carbon is sometimes used to evaluate filter cake filtration rates and the filter penetration in filtering applications.  
5.2 The selection and handling of fine mesh or powdered activated carbon, and operation of processes using fine mesh or powdered activated carbon, requires the knowledge of the particle size.  
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Note 1: Relative humidity (RH) can affect the repeatability and accuracy of this test. Activated carbon not at equilibrium with the RH of the ambient air may lose or gain weight accordingly, dependent upon whether the carbon picks up or loses moisture.
SCOPE
1.1 This test method covers the determination of the particle size of powdered activated carbons using an air-jet sieve device. For purposes of this test method, powdered activated carbon is defined as activated carbon in particle sizes predominantly in a range of 80 mesh (0.180 mm) through 500 mesh (0.025 mm).  
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Standard Guide for Liquid Dispersion of Metal Powders and Related Compounds for Particle Size Analysis

SIGNIFICANCE AND USE
4.1 The method of powder dispersion in a liquid has a significant effect on the results of a particle size distribution analysis. The analysis will show a too-coarse, unstable, or nonrepeatable distribution if the powder has not been dispersed adequately. It is therefore important that parties wishing to compare their analyses use the same dispersion technique.  
4.2 This guide provides ways of deriving dispersion techniques for a range of metal powders and compounds. It should be used by all parties performing liquid-dispersed particle size analysis of all of the materials covered by this guide (see 1.1, 1.2, and 4.1).  
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4.4 This guide should be used in the preparation of powders for use in Test Methods B761 and B822 and other procedures that analyze metal powder particle size distributions in liquid-dispersed systems.
SCOPE
1.1 This guide covers the dispersion in liquids of metal powders and related compounds for subsequent use in particle size analysis instruments. This guide describes a general procedure for achieving and determining dispersion; it also lists procedures that have been found useful for certain materials.  
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1.3 This guide is limited to metal powders and related metal compounds. However, the general procedure described herein may be used, with caution as to its significance, for other particulate materials, such as ceramics, pigments, minerals, etc.  
1.4 Units—The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
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ASTM E1638-22(Terminology)
Standard Terminology Relating to Sieves, Sieving Methods, and Screening Media

SCOPE
1.1 This terminology includes all those terms used in all of the standards under the jurisdiction of Subcommittee E29.01. Terms are defined that are related to the manufacture of standard test sieves and screening media, as well as terms related to the methods, analysis, procedures, and equipment for sizing and separating particles.  
1.2 Committee E29 on Particle and Spray Characterization feels that it is essential to include terms and definitions explicit to the scope, regardless of whether the terms appear in existing ASTM standards. Terms that are in common usage and appear in common-language dictionaries are generally not included.  
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ASTM D8200-22(Practice)
Standard Practice for Creating a Correlation to Compare Particle Size Distribution Results of Proppants by Dynamic Imaging Analyzers and Sieves

SIGNIFICANCE AND USE
5.1 The ability to correlate results of analyzers to sieve sets enables the use of non-sieve methods to be employed that give comparable results to each other.  
5.2 The use of analyzers for proppant measurement has the benefit of providing particle shape characteristics which are important in the performance of these materials. Shape analysis is currently done by operator’s determination based on a visual observation of a small number of particles per API 19C. Available information from imaging analysis of many particles can be used to assess the proppant shape characteristics as opposed to just a small number.
SCOPE
1.1 This practice describes procedural steps to create a correlation that can be used to compare results of proppant size distributions between dynamic imaging analyzers (analyzers) and prescribed sieve sets.  
1.2 The proppant size and distribution specifications that are included in this practice are listed in API Standard 19C (API 19C) and shown in Table 1, however as industry evolves additional specifications may come into use and this practice can be used with those as well.  
1.3 This practice may not be applicable to all proppant types and designations. The acceptability of the correlations determined are judged by the operator.  
1.4 The values stated in SI units are to be regarded as the standard, except sieve designations are typically identified using the ‘alternative’ system in accordance with Practice E11, such as 3 in. and No. 200 instead of the ‘standard’ system of 75 mm and 75 µm, respectively.  
1.5 Observed and calculated values shall conform to the guidelines for significant digits and rounding established in Practice D6026, unless superseded by this standard.  
1.5.1 The procedures used to specify how data are collected/recorded and calculated in Practice D6026 are regarded as the industry standard. In addition, they are representative of the significant digits that generally should be retained. The procedures used do not consider material variation, purpose for obtaining the data, special purpose studies, or any considerations for the user’s objectives; and it is common practice to increase or reduce significant digits of reported data to be commensurate with these considerations. It is beyond the scope of these test methods to consider significant digits used in analysis methods for engineering data.  
1.6 This practice offers a set of instructions for performing one or more specific operations. This document cannot replace education or experience and should be used in conjunction with professional judgment. Not all aspects of this practice may be applicable in all circumstances. This ASTM standard is not intended to represent or replace the standard of care by which the adequacy of a given professional service must be judged, nor should this document be applied without consideration of a project’s many unique aspects. The word “Standard” in the title means only that the document has been approved through the ASTM consensus process.  
1.7 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
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ASTM D2977-22(Practice)
Standard Practice for Particle Size Range of Peat Materials for Horticultural Purposes

SIGNIFICANCE AND USE
5.1 This practice is primarily used in the horticulture industry to separates peat material into arbitrary fractions based on particle size. Physical separation of peat material according to particle size provides a useful indicator of the properties of a peat specimen such as pore space and degree of decomposition for unprocessed peat. It also provides a means of determining the amount of foreign matter not in a divided state such as sticks, stones, and glass.
Note 1: The quality of the result produced by this standard is dependent on the competence of the personnel performing it, and the suitability of the equipment and facilities used. Agencies that meet the criteria of Practice D3740 are generally considered capable of competent and objective testing/sampling/inspection/etc. Users of this standard are cautioned that compliance with Practice D3740 does not in itself assure reliable results. Reliable results depend on many factors; Practice D3740 provides a means of evaluating some of those factors.
SCOPE
1.1 Peat materials consist of particles with various sizes. This practice covers the separation of peat particles into coarse, medium, and fine size fractions using the 2.36 mm (No. 8) and 0.850 mm (No. 20) sieves equipped with cover and bottom pan. This practice is applicable for peat materials used in the horticultural industry and can be used to verify the degree of decomposition of peat and to determine the foreign matter content.  
1.2 Units—The values stated in SI units are to be regarded as standard. The values given in parentheses are provided for information only and are not considered standard. Reporting of test results in units other than SI shall not be regarded as nonconformance with this standard.  
1.2.1 It is common practice in the engineering/construction profession to concurrently use pounds to represent both a unit of mass (lbm) and of force (lbf). This practice implicitly combines two separate systems of units; the absolute and the gravitational systems. It is scientifically undesirable to combine the use of two separate sets of inch-pound units within a single standard. As stated, this standard includes the gravitational system of inch-pound units and does not use/present the slug unit of mass. However, the use of balances and scales recording pounds of mass (lbm) or recording density in lbm/ft3 shall not be regarded as nonconformance with this standard.  
1.3 All observed and calculated values shall conform to the guidelines for significant digits and rounding established in Practice D6026.  
1.3.1 The procedures used to specify how data are collected/recorded or calculated in this standard are regarded as the industry standard. In addition, they are representative of the significant digits that generally should be retained. The procedures used do not consider material variation, purpose for obtaining the data, special purpose studies, or any considerations for the user’s objectives; and it is common practice to increase or reduce significant digits of reported data to be commensurate with these considerations. It is beyond the scope of this standard to consider significant digits used in analysis methods for engineering design.  
1.4 This practice offers a set of instructions for performing one or more specific operations. This document cannot replace education or experience and should be used in conjunction with professional judgment. Not all aspects of this practice may be applicable in all circumstances. This ASTM standard is not intended to represent or replace the standard of care by which the adequacy of a given professional service must be judged, nor should this document be applied without consideration of a project’s many unique aspects. The word “Standard” in the title of this document means only that the document has been approved through the ASTM consensus process.  
1.5 This standard does not purport to address all of the safety concerns, if any...

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ASTM D4513-22(Test Method)
Standard Test Method for Particle Size Distribution of Catalytic Materials by Sieving

SIGNIFICANCE AND USE
4.1 This test method can be used to determine particle size distributions of catalysts and supports for materials specifications, manufacturing control, and research and development work.
SCOPE
1.1 This test method covers the determination of particle size distribution of catalytic powder material using a sieving instrument and is one of several found valuable for the measurement of particle size. This test method is particularly suitable for particles in the 20 to 420 μm range. (See Terminology D3766.)  
1.2 Units—The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.2.1 Exception—In 5.2, mesh size is the standard unit of measure.  
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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

  • Standard
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  • Standard
    3 pages
    English language
    sale 15% off