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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 047 Date of Entry 08/21/2017 
FR Recognition Number 8-456
Standard
ISO 13179-1 First edition 2014-06-01
Implants for surgery--Plasma-sprayed unalloyed titanium coatings on metallic surgical implants -- Part 1: General requirements
Scope/Abstract
This part of ISO 13179 specifies general requirements for plasma-sprayed unalloyed titanium coatings on metallic surgical implants.

This part of ISO 13179 applies to plasma spraying in air and in vacuum.

This part of ISO 13179 does not apply to coatings made of other materials than unalloyed titanium or coatings realized by another technology than plasma spraying.

NOTE 1 A quality management system can be useful, e.g. as described in ISO 13485. Requirements for the competence of testing laboratories can be found in ISO/IEC 17025.
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FDA recognition of ISO 13179-1 First edition 2014-06-01 [Rec# 8-456] will be superseded by recognition of ISO 13179-1 Second Edition 2021-09 [Rec# 8-577]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 8-456] until December 18th, 2022. After this transition period, declarations of conformity to [Rec# 8-456] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Implantable Metallic Medical Devices
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

Guidance for Industry on the Testing of Metallic Plasma Sprayed Coatings on Orthopedic Implants to Support Reconsideration of Postmarket Surveillance Requirements, February 2, 2000


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)
Materials
*These are provided as examples and others may be applicable.
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