1. 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.

2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.

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

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 Particle Counter (Discontinued 2000)

F662 Test Method for Measurement of Particle Count and Size Distribution in Batch Samples for Filter Evaluation Using an Electrical Resistance Particle Counter (Discontinued 2002)

F732 Test Method for Wear Testing of Polymeric Materials Used in Total Joint Prostheses

F1714 Guide for Gravimetric Wear Assessment of Prosthetic Hip Designs in Simulator Devices

F1715 Guide for Wear Assessment of Prosthetic Knee Designs in Simulator Devices

Keywords

biocompatibility; morphology; particles; SEM; wear debris; Biocompatibility; Morphology; Particle analysis--medical/surgical applications; Scanning electron microscope (SEM); Wear debris; Wear testing--surgical implant materials/applications;

ICS Code

ICS Number Code 19.120 (Particle size analysis. Sieving)

DOI: 10.1520/F1877-98R03E01

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