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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 052 Date of Entry 07/15/2019 
FR Recognition Number 8-513
ISO 20160 First edition 2006-05-01
Implants for surgery - Metallic materials - Classification of microstructures for alpha+beta titanium alloy bars
This International Standard provides a catalogue of metallographic photomicrographs for the designation of microstructures of alpha+beta titanium alloys in the form of bars that are intended for the manufacture of surgical implants. This International Standard is applicable to bars of diameter no greater than 100 mm or the equivalent.

This catalogue of microstructures is intended to serve as an aid in the communication on general types of microstructures of alpha+beta titanium alloy bars. The designation of the microstructures is based on morphological appearance. Actual microstructures can also appear as a combination of the type of micrographs shown.

This International Standard does not contain specific microstructural requirements. The catalogue includes photomicrographs of desirable and undesirable microstructures that can develop during the processing of alpha+beta titanium alloys. The selection of acceptable microstructures is subject to agreement under the consideration of implant application and relevant material standards.
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*
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
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
*These are provided as examples and others may be applicable.