BS ISO 17853:2011
Current
The latest, up-to-date edition.
Wear of implant materials. Polymer and metal wear particles. Isolation and characterization
Hardcopy , PDF
English
31-03-2011
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Foreword
Introduction
1 Scope
2 Terms and definitions
3 Principle, reagents and apparatus
4 Methods of sampling and analysis of polymer and metal
wear particles from tissue samples
5 Methods of sampling and analysis of polymer and metal
particles from joint simulator lubricants
6 Test report
Bibliography
Describes the methods for sampling wear particles generated by joint replacement implants in humans and in joint simulators.
| Committee |
CH/150/4
|
| DevelopmentNote |
Supersedes 02/563039 DC. (01/2005) Supersedes 08/30174997 DC. (07/2010)
|
| DocumentType |
Standard
|
| Pages |
26
|
| PublisherName |
British Standards Institution
|
| Status |
Current
|
| Supersedes |
This International Standard specifies methods for sampling wear particles generated by joint replacement implants in humans and in joint simulators. It specifies the apparatus, reagents and test methods to isolate and characterize both polymer and metal wear particles from samples of tissues excised from around the joint replacement implant, obtained at revision surgery or post mortem, and from samples of joint simulator test fluids. Some of these procedures could certainly be adapted for isolation and characterization of particles from human biological fluids (e.g. synovial fluid).
The methods given in this International Standard do not quantify the level of wear the implant produces; neither do they determine the amount of wear from any particular surface. This International Standard does not cover the biological effects of wear particles or provide a method for evaluation of biological safety.
| Standards | Relationship |
| ISO 17853:2011 | Identical |
| ASTM F 1877 : 2016 : REDLINE | Standard Practice for Characterization of Particles |
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