ASTM F1877-16

Standard Practice for Characterization of Particles

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.  
1.8 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: Published
• Publication Date: 30-Sep-2016
• ICS: 19.120 - Particle size analysis. Sieving
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.16 - Biocompatibility Test Methods

Relations

• Refers: ASTM C242-15 - Standard Terminology of Ceramic Whitewares and Related Products
• Effective Date: 01-Mar-2015
• Refers: ASTM F732-17 - Standard Test Method for Wear Testing of Polymeric Materials Used in Total Joint Prostheses
• Effective Date: 01-Sep-2017
• Refers: ASTM F1714-96(2018) - Standard Guide for Gravimetric Wear Assessment of Prosthetic Hip Designs in Simulator Devices
• Effective Date: 01-Apr-2018
• Refers: ASTM E1617-09(2019) - Standard Practice for Reporting Particle Size Characterization Data
• Effective Date: 01-Apr-2019
• Refers: ASTM C242-18 - Standard Terminology of Ceramic Whitewares and Related Products
• Effective Date: 01-Feb-2018
• Refers: ASTM C242-19 - Standard Terminology of Ceramic Whitewares and Related Products
• Effective Date: 01-Aug-2019
• Refers: ASTM E766-14(2019) - Standard Practice for Calibrating the Magnification of a Scanning Electron Microscope
• Effective Date: 01-Nov-2019
• Refers: ASTM F660-83(2019) - Standard Practice for Comparing Particle Size in the Use of Alternative Types of Particle Counters
• Effective Date: 01-Nov-2019
• Refers: ASTM C242-19a - Standard Terminology of Ceramic Whitewares and Related Products
• Effective Date: 01-Oct-2019
• Refers: ASTM C242-20 - Standard Terminology of Ceramic Whitewares and Related Products
• Effective Date: 01-Feb-2020
• Referred By: ASTM F1903-18 - Standard Practice for Testing for Cellular Responses to Particles <emph type="bdit" >in vitro</emph>
• Effective Date: 01-Oct-2016
• 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-Oct-2016
• Referred By: ASTM F561-19 - Standard Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and Fluids
• Effective Date: 01-Oct-2016
• Referred By: ASTM F2027-16 - Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products
• Effective Date: 01-Oct-2016
• 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-Oct-2016
• Referred By: ASTM F2789-10(2020) - Standard Guide for Mechanical and Functional Characterization of Nucleus Devices
• Effective Date: 01-Oct-2016
• Referred By: ASTM F2665-21 - Standard Specification for Total Ankle Replacement Prosthesis
• Effective Date: 01-Oct-2016
• Referred By: ASTM F2694-16(2020) - Standard Practice for Functional and Wear Evaluation of Motion-Preserving Lumbar Total Facet Prostheses
• Effective Date: 01-Oct-2016
• Referred By: ASTM F2423-11(2020) - Standard Guide for Functional, Kinematic, and Wear Assessment of Total Disc Prostheses
• Effective Date: 01-Oct-2016
• 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-Oct-2016
• 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-Oct-2016
• Referred By: ASTM E2490-09(2021) - Standard Guide for Measurement of Particle Size Distribution of Nanomaterials in Suspension by Photon Correlation Spectroscopy (PCS)
• Effective Date: 01-Oct-2016
• Referred By: ASTM F3295-18 - Standard Guide for Impingement Testing of Total Disc Prostheses
• Effective Date: 01-Oct-2016
• Referred By: ASTM E3238-20 - Standard Test Method for Quantitative Measurement of the Chemoattractant Capacity of a Nanoparticulate Material <emph type="bdit">in vitro</emph>
• Effective Date: 01-Oct-2016
• Referred By: ASTM E2524-22 - Standard Test Method for Analysis of Hemolytic Properties of Nanoparticles
• Effective Date: 01-Oct-2016
• 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-Oct-2016
• Referred By: ASTM F2083-21 - Standard Specification for Knee Replacement Prosthesis
• Effective Date: 01-Oct-2016
• 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-Oct-2016
• Referred By: ASTM F2603-06(2020) - Standard Guide for Interpreting Images of Polymeric Tissue Scaffolds
• Effective Date: 01-Oct-2016
• Referred By: ASTM F748-16 - Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
• Effective Date: 01-Oct-2016
• Referred By: ASTM E3351-22 - Standard Test Method for Detection of Nitric Oxide Production <emph type="bdit">In Vitro</emph >
• Effective Date: 01-Oct-2016
• Referred By: ASTM F3047M-23 - Standard Guide for High Demand Hip Simulator Wear Testing of Hard-on-Hard Articulations
• Effective Date: 01-Oct-2016

Standards Content (Sample)

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.
Designation: F1877 − 16
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
2.1 ASTM Standards:
1.1 This practice covers a series of procedures for charac-
C242 Terminology of Ceramic Whitewares and Related
terization of the morphology, number, size, and size distribu-
Products
tion of particles. The methods utilized include sieves, optical,
C678 Test Method for Determination of Particle Size Distri-
scanning electron microscopy (SEM), transmission electron
bution of Alumina or Quartz Using Centrifugal Sedimen-
microscopy (TEM), and electrooptical.
3
tation (Withdrawn 1995)
1.2 Thesemethodsareappropriateforparticlesproducedby
E11 Specification for Woven Wire Test Sieve Cloth and Test
a number of different methods. These include wear test
Sieves
machines (Test Method F732), total joint simulation systems E161 Specification for Precision Electroformed Sieves
(Guides F1714 and F1715), abrasion testing, methods for E766 Practice for Calibrating the Magnification of a Scan-
ning Electron Microscope
producing particulates, such as shatter boxes or pulverizers,
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
1.3 The debris may include metallic, polymeric, ceramic, or
Devices, and Associated Tissues and Fluids
any combination of these.
F660 Practice for Comparing Particle Size in the Use of
Alternative Types of Particle Counters
1.4 The digestion procedures to be used and issues of
F661 Practice for Particle Count and Size Distribution Mea-
sterilization of retrieved particles are not the subject of this
surement in Batch Samples for Filter Evaluation Using an
practice.
Optical Particle Counter (Discontinued 2000) (Withdrawn
3
1.5 A classification scheme for description of particle mor-
2000)
phology is included in Appendix X3.
F662 Test Method for Measurement of Particle Count and
Size Distribution in Batch Samples for Filter Evaluation
1.6 The values stated in SI units are to be regarded as
Using an Electrical Resistance Particle Counter (Discon-
standard. No other units of measurement are included in this
3
tinued 2002) (Withdrawn 2002)
standard.
F732 Test Method for Wear Testing of Polymeric Materials
1.7 As a precautionary measure, removed debris from Used in Total Joint Prostheses
F1714 GuideforGravimetricWearAssessmentofProsthetic
implanttissuesshouldbesterilizedorminimallydisinfectedby
Hip Designs in Simulator Devices
an appropriate means that does not adversely affect the
F1715 Guide for Wear Assessment of Prosthetic Knee De-
particulate material.
3
signs in Simulator Devices (Withdrawn 2006)
1.8 This standard does not purport to address all of the
safety concerns, if any, associated with its use. It is the
3. Terminology
responsibility of the user of this standard to establish appro-
3.1 Definitions of Terms Specific to This Standard:
priate safety and health practices and determine the applica-
3.1.1 agglomerate, n—a jumbled mass or collection of two
bility of regulatory limitations prior to use.
or more particles or aggregates, or a combination thereof, held
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 [e-mail]. 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 Oct. 1, 2016. Published October 2016. Originally the ASTM website.
3
approved in 1998. Last previous edition approved in 2010 as F1877 – 05 (2010). The last approved version of this historical standard is referenced on
DOI: 10.1520/F1877-16. www.astm.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F1877 − 16
together by relatively weak cohesive forces caused by weak 5. Significance and Use
chemical bonding or an electrostatic surface charge generated
5.1 Thebiologicalresponsetomaterialsintheformofsmall
by handling or proc
...

This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation: F1877 − 05 (Reapproved 2010) F1877 − 16
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
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, 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 pulverizors,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 X3Appendix 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.
1.8 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.
2. Referenced Documents
2
2.1 ASTM Standards:
C242 Terminology of Ceramic Whitewares and Related Products
C678 Test Method for Determination of Particle Size Distribution of Alumina or Quartz Using Centrifugal Sedimentation
3
(Withdrawn 1995)
E11 Specification for Woven Wire Test Sieve Cloth and Test Sieves
E161 Specification for Precision Electroformed Sieves
E766 Practice for Calibrating the Magnification of a Scanning Electron Microscope
E1617 Practice for Reporting Particle Size Characterization Data
F561 Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and Fluids
F660 Practice for Comparing Particle Size in the Use of Alternative Types of Particle Counters
F661 Practice for Particle Count and Size Distribution Measurement in Batch Samples for Filter Evaluation Using an Optical
3
Particle Counter (Discontinued 2000) (Withdrawn 2000)
F662 Test Method for Measurement of Particle Count and Size Distribution in Batch Samples for Filter Evaluation Using an
3
Electrical Resistance Particle Counter (Discontinued 2002) (Withdrawn 2002)
F732 Test Method for Wear Testing of Polymeric Materials Used in Total Joint Prostheses
1
This practice is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee F04.16
on Biocompatibility Test Methods.
Current edition approved June 1, 2010Oct. 1, 2016. Published September 2010October 2016. Originally approved in 1998. Last previous edition approved in 20052010
ε1
as F1877 – 05 (2010). . DOI: 10.1520/F1877-05R10. 10.1520/F1877-16.
2
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’sstandard’s Document Summary page on the ASTM website.
3
The last approved version of this historical standard is referenced 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
1

---------------------- Page: 1 ----------------------
F1877 − 16
F1714 Guide for Gravimetric Wear Assessment of Prosthetic Hip Designs in Simula
...