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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 8-467
Standard
ASTM  F1978-18
Standard Test Method for Measuring Abrasion Resistance of Metallic Thermal Spray Coatings by Using the Taber Abraser
Scope/Abstract
1.1 This test method quantifies the abrasion resistance of metallic coatings produced by thermal spray processes on flat metallic surfaces. It is intended as a means of characterizing coatings used on surgical implants.
1.2 This test uses the Taber Abraser,2 which generates a combination of rolling and rubbing to cause wear to the coating surface. Wear is quantified as cumulative weight loss.
1.3 This test method is limited to flat, rigid specimens that do not react significantly with water and do not undergo a phase transformation or chemical reaction between room temperature and 100°C in air.
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.
Transition Period
FDA recognition of ASTM F1978-18 [Rec# 8-467] will be superseded by recognition of ASTM F1978-22 [Rec# 8-600]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 8-467] until July 5, 2026. After this transition period, declarations of conformity to [Rec# 8-467] will not be accepted.
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, Issued April 1994.

510(K) Information Needed for Hydroxyapatite Coated Orthopedic Implants, Issued March 1995 (revised 2/20/97).

Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments, Issued May 2004.

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
 Terry O. Woods
  FDA/OC/CDRH/OSEL/DAM/
  301-796-2503
  terry.woods@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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