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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 041 Date of Entry 04/04/2016 
FR Recognition Number 8-400
Standard
ASTM  F1854-15
Standard Test Method for Stereological Evaluation of Porous Coatings on Medical Implants
Scope/Abstract
1.1 This test method covers stereological test methods for characterizing the coating thickness, void content, and mean intercept length of various porous coatings adhering to nonporous substrates.

1.2 A method to measure void content and intercept length at distinct levels ("Tissue Interface Gradients") through the porous coating thickness is outlined in 9.4.
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.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
§888.3535 Knee joint femorotibial (uni-compartmental) metal/polymer porous-coated uncemented prosthesis.
§888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.
§888.3670 Shoulder joint metal/polymer/metal nonconstrained or semi-constrained porous-coated uncemented prosthesis.
Relevant FDA Guidance and/or Supportive Publications*
Guidance Document for Testing Orthopedic Implants With Modified Metallic Surfaces Apposing Bone Or Bone Cement, April 28, 1994

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
 Matthew Di Prima
  FDA/OC/CDRH/OSEL/DAM/
  301-796-2507
  matthew.diprima@fda.hhs.gov
Standards Development Organization
ASTM ASTM International http://www.astm.org/
FDA Specialty Task Group (STG)
Materials
*These are provided as examples and others may be applicable.
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