1、Designation:F187705(Reapproved 2010)Standard Practice forCharacterization of Particles1This standard is issued under the fixed designation F1877;the number immediately following the designation indicates the year oforiginal adoption or,in the case of revision,the year of last revision.A number in pa
2、rentheses indicates the year of last reapproval.Asuperscript epsilon()indicates an editorial change since the last revision or reapproval.1.Scope1.1 This practice covers a series of procedures for charac-terization of the morphology,number,size,and size distribu-tion of particles.The methods utilize
3、d include sieves,optical,SEM,and electrooptical.1.2 These methods are appropriate for particles produced bya number of different methods.These include wear testmachines(Test Method F732),total joint simulation systems(Guides F1714 and F1715),abrasion testing,methods forproducing particulates,such as
4、 shatter boxes or pulverizors,commercially available particles,and particles harvested fromtissues in animal or clinical studies.1.3 The debris may include metallic,polymeric,ceramic,orany combination of these.1.4 The digestion procedures to be used and issues ofsterilization of retrieved particles
5、are not the subject of thispractice.1.5 A classification scheme for description of particle mor-phology is included in Appendix X3.1.6 The values stated in SI units are to be regarded asstandard.No other units of measurement are included in thisstandard.1.7 As a precautionary measure,removed debris
6、fromimplant tissues should be sterilized or minimally disinfected byan appropriate means that does not adversely affect theparticulate material.This standard does not purport to addressall of the safety concerns,if any,associated with its use.It isthe responsibility of the user of this standard to e
7、stablishappropriate safety and health practices and determine theapplicability of regulatory limitations prior to use.2.Referenced Documents2.1 ASTM Standards:2C242 Terminology of Ceramic Whitewares and RelatedProductsC678 Test Method for Determination of Particle Size Distri-bution of Alumina or Qu
8、artz Using Centrifugal Sedimen-tation(Withdrawn 1995)3E11 Specification for Woven Wire Test Sieve Cloth and TestSievesE161 Specification for Precision Electroformed SievesE766 Practice for Calibrating the Magnification of a Scan-ning Electron MicroscopeE1617 Practice for Reporting Particle Size Char
9、acterizationDataF561 Practice for Retrieval and Analysis of MedicalDevices,and Associated Tissues and FluidsF660 Practice for Comparing Particle Size in the Use ofAlternative Types of Particle CountersF661 Practice for Particle Count and Size Distribution Mea-surement in Batch Samples for Filter Eva
10、luation Using anOptical Particle Counter(Discontinued 2000)(Withdrawn2000)3F662 Test Method for Measurement of Particle Count andSize Distribution in Batch Samples for Filter EvaluationUsing an Electrical Resistance Particle Counter(Discon-tinued 2002)(Withdrawn 2002)3F732 Test Method for Wear Testi
11、ng of Polymeric MaterialsUsed in Total Joint ProsthesesF1714 Guide for Gravimetric WearAssessment of ProstheticHip Designs in Simulator DevicesF1715 Guide for Wear Assessment of Prosthetic Knee De-signs in Simulator Devices(Withdrawn 2006)31This practice is under the jurisdiction ofASTM Committee F0
12、4 on Medical andSurgical Materials and Devices and is the direct responsibility of SubcommitteeF04.16 on Biocompatibility Test Methods.Current edition approved June 1,2010.Published September 2010.Originallyapproved in 1998.Last previous edition approved in 2005 as F1877 051.DOI:10.1520/F1877-05R10.
13、2For referenced ASTM standards,visit the ASTM website,www.astm.org,orcontact ASTM Customer Service at serviceastm.org.For Annual Book of ASTMStandards volume information,refer to the standards Document Summary page onthe ASTM website.3The last approved version of this historical standard is referenc
14、ed onwww.astm.org.*A Summary of Changes section appears at the end of this standardCopyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 3.Terminology3.1 Definitions of Terms Specific to This Standard:3.1.1 agglomerate,na jumbled mass or collec
15、tion of twoor more particles or aggregates,or a combination thereof,heldtogether by relatively weak cohesive forces caused by weakchemical bonding or an electrostatic surface charge generatedby handling or processing.3.1.2 aggregate,na dense mass of particles held togetherby strong intermolecular or
16、 atomic cohesive forces that isstable to normal mixing techniques,including high-speedstirring and ultrasonics.3.1.3 aspect ratio(AR),na ratio of the major to the minordiameter of a particle,which can be used when the major axisdoes not cross a particle outline(see 11.3.3).3.1.4 elongation(E),nratio of the particle length to theaverage particle width(see 11.3.4).3.1.5 equivalent circle diameter(ECD),na measure of thesize of a particle(see 11.3.2 and Appendix X1).3.1.6 Feret diameter,nthe mean va
