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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 041 Date of Entry 04/04/2016 
FR Recognition Number 8-406
Standard
ISO 5832-11 Second edition 2014-09-15
Implants for surgery -- Metallic materials -- Part 11: Wrought titanium 6-aluminium 7-niobium alloy
Scope/Abstract
This part of ISO 5832 specifies the characteristics of, and corresponding test methods for, the wrought titanium alloy known as titanium 6-aluminium 7-niobium alloy (Ti-6-Al 7-Nb) for use in the manufacture of surgical implants.

NOTE The mechanical properties of a sample obtained from a finished product made of this alloy might not necessarily comply with those specified in this part of ISO 5832.
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)*
21 CFR 888.3XXX Metallic components of all implantables
21 CFR 872.4XXX Metallic components
Regulation Number Device Name Device Class Product Code
§872.3640 Implant, Endosseous, Root-Form Class 2 DZE
Regulation Number Device Name Device Class Product Code
§872.3645 Implant, Subperiosteal Class 2 ELE
Regulation Number Device Name Device Class Product Code
§872.3890 Splint, Endodontic Stabilizing Class 2 ELS
Regulation Number Device Name Device Class Product Code
§872.3940 Joint, Temporomandibular, Implant Class 3 LZD
Regulation Number Device Name Device Class Product Code
§872.3950 Glenoid Fossa Prosthesis Class 3 MPI
Regulation Number Device Name Device Class Product Code
§872.3960 Mandibular Condyle Prosthesis Class 3 MPL
Regulation Number Device Name Device Class Product Code
§872.4600 Lock, Wire, And Ligature, Intraoral Class 2 DYX
Regulation Number Device Name Device Class Product Code
§872.4760 External Mandibular Fixator And/Or Distractor Class 2 MQN
§872.4760 Implant, Transmandibular Class 2 MDL
§872.4760 Plate, Bone Class 2 JEY
Regulation Number Device Name Device Class Product Code
§872.4880 Screw, Fixation, Intraosseous Class 2 DZL
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 Contacts
 Andrew Steen
  FDA/OC/CDRH/OPEQ/OHTI/DHTIB/
  301-796-6284
  Andrew.Steen@fda.hhs.gov
 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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