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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 050 Date of Entry 09/17/2018 
FR Recognition Number 11-336
Standard
ISO  17853 Third edition 2011-03-01
Wear of implant materials - Polymer and metal wear particles - Isolation and characterization
Scope/Abstract
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.
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Relevant FDA Guidance and/or Supportive Publications*
Guidance for Industry and Food and Drug Administration Staff: Use of International Standard ISO 10993-1, Biological evaluation of medical devices--Part 1: Evaluation and testing within a risk management process, Issued June 2016



Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contact
 John Goode
  FDA/OC/CDRH/OPEQ/OHTVI/DHTVIA/
  301-796-6407
  john.goode@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
Orthopedic
*These are provided as examples and others may be applicable.
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