ASTM F1877-05
(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 outlines 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, total joint simulation systems, 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 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
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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
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.
1. Scope* E11 SpecificationforWovenWireTestSieveClothandTest
Sieves
1.1 This practice covers a series of procedures for charac-
E161 Specification for Precision Electroformed Sieves
terization of the morphology, number, size, and size distribu-
E766 Practice for Calibrating the Magnification of a Scan-
tion of particles. The methods utilized include sieves, optical,
ning Electron Microscope
SEM, and electrooptical.
E1617 Practice for Reporting Particle Size Characterization
1.2 Thesemethodsareappropriateforparticlesproducedby
Data
a number of different methods. These include wear test
F561 Practice for Retrieval and Analysis of Medical De-
machines (Test Method F732), total joint simulation systems
vices, and Associated Tissues and Fluids
(Guides F1714 and F1715), abrasion testing, methods for
F660 Practice for Comparing Particle Size in the Use of
producing particulates, such as shatter boxes or pulverizors,
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Alternative Types of Particle Counters
commercially available particles, and particles harvested from
F661 Practice for Particle Count and Size Distribution
tissues in animal or clinical studies.
MeasurementinBatchSamplesforFilterEvaluationUsing
1.3 The debris may include metallic, polymeric, ceramic, or
43
an Optical Particle Counter (Discontinued 2000)
any combination of these.
F662 Test Method for Measurement of Particle Count and
1.4 The digestion procedures to be used and issues of
Size Distribution in Batch Samples for Filter Evaluation
sterilization of retrieved particles are not the subject of this
Using an Electrical Resistance Particle Counter (Discon-
practice.
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tinued 2002)
1.5 A classification scheme for description of particle mor-
F732 Test Method for Wear Testing of Polymeric Materials
phology is included in Appendix X3.
Used in Total Joint Prostheses
1.6 As a precautionary measure, removed debris from
F1714 Guide for Gravimetric Wear Assessment of Pros-
implanttissuesshouldbesterilizedorminimallydisinfectedby
thetic Hip Designs in Simulator Devices
an appropriate means that does not adversely affect the
F1715 Guide for Wear Assessment of Prosthetic Knee
particulate material. This standard does not purport to address
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Designs in Simulator Devices
all of the safety concerns, if any, associated with its use. It is
the responsibility of the user of this standard to establish
3. Terminology
appropriate safety and health practices and determine the
3.1 Definitions of Terms Specific to This Standard:
applicability of regulatory limitations prior to use.
3.1.1 agglomerate, n—a jumbled mass or collection of two
2. Referenced Documents or more particles or aggregates, or a combination thereof, held
2 together by relatively weak cohesive forces caused by weak
2.1 ASTM Standards:
chemical bonding or an electrostatic surface charge generated
C242 Terminology of Ceramic Whitewares and Related
3 by handling or processing.
Products
3.1.2 aggregate, n—a dense mass of particles held together
C678 NO TITLE
by strong intermolecular or atomic cohesive forces that is
stable to normal mixing techniques, including high-speed
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stirring and ultrasonics.
ThispracticeisunderthejurisdictionofASTMCommitteeF04onMedicaland
Surgical Materials and Devices and is the direct responsibility of Subcommittee
3.1.3 aspect ratio (AR), n—a ratio of the major to the minor
F04.16 on Biocompatibility Test Methods.
diameter of a particle, which can be used when the major axis
Current edition approved Nov. 1, 2005. Published November 2005. Originally
´1 does not cross a particle outline (see 11.3.3).
approved in 1998. Last previous edition approved in 2003 as F1877 – 98 (2003) .
3.1.4 elongation (E), n—ratio of the particle length to the
DOI: 10.1520/F1877-05.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
average particle width (see 11.3.4).
contact ASTM Customer Service at service@astm.org. 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. The last approved version of this historical standard is referenced
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Withdrawn. on 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.
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F1877 – 05
3.1.5 equivalentcirclediameter(ECD),n—ameasur
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