Recognized standard

20160 First edition 2006-05-01

FDA recognition 8-513 · ISO · Materials

Key facts

Recognition number 8-513
Designation 20160 First edition 2006-05-01
Title Implants for surgery - Metallic materials - Classification of microstructures for alpha+beta titanium alloy bars
Standards developer International Organization for Standardization
Specialty area Materials
Date of entry Jul 15, 2019
Scope (excerpt) 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…

At a glance

  • None Product codes
  • 1–9 FDA guidance documents

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA-recognized consensus standards

The FDA recognizes voluntary consensus standards that manufacturers can cite in premarket submissions to show conformity with specific requirements.

Source: U.S. Food and Drug Administration (FDA), Recognized Consensus Standards database · Source date:

Browse all FDA-recognized consensus standards