ASTM F1877-05e1

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-Oct-2005
• ICS: 19.120 - Particle size analysis. Sieving
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.16 - Biocompatibility Test Methods

Relations

• Replaces: ASTM F1877-05 - Standard Practice for Characterization of Particles
• Effective Date: 01-Nov-2005
• Replaced By: ASTM F1877-05(2010) - Standard Practice for Characterization of Particles
• 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-Nov-2005
• Referred By: ASTM F2083-21 - Standard Specification for Knee Replacement Prosthesis (Withdrawn 2023)
• Effective Date: 01-Nov-2005
• Referred By: ASTM F561-19 - Standard Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and Fluids
• Effective Date: 01-Nov-2005
• Referred By: ASTM F2789-10(2020) - Standard Guide for Mechanical and Functional Characterization of Nucleus Devices
• Effective Date: 01-Nov-2005
• Referred By: ASTM F2624-12(2020) - Standard Test Method for Static, Dynamic, and Wear Assessment of Extra-Discal Single Level Spinal Constructs
• Effective Date: 01-Nov-2005
• Referred By: ASTM F2603-06(2020) - Standard Guide for Interpreting Images of Polymeric Tissue Scaffolds
• Effective Date: 01-Nov-2005
• Referred By: ASTM F3335-20 - Standard Guide for Assessing the Removal of Additive Manufacturing Residues in Medical Devices Fabricated by Powder Bed Fusion
• Effective Date: 01-Nov-2005
• Referred By: ASTM E2524-22 - Standard Test Method for Analysis of Hemolytic Properties of Nanoparticles
• Effective Date: 01-Nov-2005
• Referred By: ASTM F2665-21 - Standard Specification for Total Ankle Replacement Prosthesis
• Effective Date: 01-Nov-2005
• Referred By: ASTM F2847-17 - Standard Practice for Reporting and Assessment of Residues on Single-Use Implants and Single-Use Sterile Instruments
• Effective Date: 01-Nov-2005
• Referred By: ASTM E3351-22 - Standard Test Method for Detection of Nitric Oxide Production <emph type="bdit">In Vitro</emph >
• Effective Date: 01-Nov-2005
• Referred By: ASTM F748-16 - Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
• Effective Date: 01-Nov-2005
• 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-Nov-2005

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
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Designation: F1877 – 05
Standard Practice for
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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.
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´ NOTE—Figures X2.18 and X2.19 were corrected and the units statement was added editorially in May 2010.
1. Scope* C242 Terminology of Ceramic Whitewares and Related
Products
1.1 This practice covers a series of procedures for charac-
C678 Test Method for Determination of Particle Size Dis-
terization of the morphology, number, size, and size distribu-
tribution of Alumina or Quartz Using Centrifugal Sedi-
tion of particles. The methods utilized include sieves, optical,
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mentation
SEM, and electrooptical.
E11 SpecificationforWovenWireTestSieveClothandTest
1.2 Thesemethodsareappropriateforparticlesproducedby
Sieves
a number of different methods. These include wear test
E161 Specification for Precision Electroformed Sieves
machines (Test Method F732), total joint simulation systems
E766 Practice for Calibrating the Magnification of a Scan-
(Guides F1714 and F1715), abrasion testing, methods for
ning Electron Microscope
producing particulates, such as shatter boxes or pulverizors,
E1617 Practice for Reporting Particle Size Characterization
commercially available particles, and particles harvested from
Data
tissues in animal or clinical studies.
F561 Practice for Retrieval and Analysis of Medical De-
1.3 The debris may include metallic, polymeric, ceramic, or
vices, and Associated Tissues and Fluids
any combination of these.
F660 Practice for Comparing Particle Size in the Use of
1.4 The digestion procedures to be used and issues of
Alternative Types of Particle Counters
sterilization of retrieved particles are not the subject of this
F661 Practice for Particle Count and Size Distribution
practice.
MeasurementinBatchSamplesforFilterEvaluationUsing
1.5 A classification scheme for description of particle mor-
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an Optical Particle Counter
phology is included in Appendix X3.
F662 Test Method for Measurement of Particle Count and
1.6 The values stated in SI units are to be regarded as
Size Distribution in Batch Samples for Filter Evaluation
standard. No other units of measurement are included in this
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Using an Electrical Resistance Particle Counter
standard.
F732 Test Method for Wear Testing of Polymeric Materials
1.7 As a precautionary measure, removed debris from
Used in Total Joint Prostheses
implanttissuesshouldbesterilizedorminimallydisinfectedby
F1714 Guide for Gravimetric Wear Assessment of Pros-
an appropriate means that does not adversely affect the
thetic Hip Designs in Simulator Devices
particulate material. This standard does not purport to address
F1715 Guide for Wear Assessment of Prosthetic Knee
all of the safety concerns, if any, associated with its use. It is
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Designs in Simulator Devices
the responsibility of the user of this standard to establish
appropriate safety and health practices and determine the
3. Terminology
applicability of regulatory limitations prior to use.
3.1 Definitions of Terms Specific to This Standard:
2. Referenced Documents 3.1.1 agglomerate, n—a jumbled mass or collection of two
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or more particles or aggregates, or a combination thereof, held
2.1 ASTM Standards:
together by relatively weak cohesive forces caused by weak
chemical bonding or an electrostatic surface charge generated
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by handling or processing.
ThispracticeisunderthejurisdictionofASTMCommitteeF04onMedicaland
Surgical Materials and Devices and is the direct responsibility of Subcommittee
3.1.2 aggregate, n—a dense mass of particles held together
F04.16 on Biocompatibility Test Methods.
by strong intermolecular or atomic cohesive forces that is
Current edition approved Nov. 1, 2005. Published November 2005. Originally
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stable to normal mixing techniques, including high-speed
approved in 1998. Last previous edition approved in 2003 as F1877 – 98 (2003) .
DOI: 10.1520/F1877-05E01. stirring and ultrasonics.
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For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
Standards volume information, refer to the standard’s Document Summary page on
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the ASTM website. Withdrawn.
*A Summary of Changes section appears at the end of this standard.
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F1877 – 05
3.1.3 aspect ratio (AR), n—a ratio of the major to the minor 5.2 The quantity, size, and morphology of par
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