• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Recognized Consensus Standards

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 047 Date of Entry 08/21/2017 
FR Recognition Number 8-447
Standard
ISO 5832-3 Fourth edition 2016-10-15
Implants for surgery -- Metallic materials -- Part 3: Wrought titanium 6-aluminium 4-vanadium 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 4-vanadium alloy (Ti 6-AI4-V alloy) for use in the manufacture of surgical implants.

NOTE The mechanical properties of a sample obtained from a finished product made of this alloy may not necessarily comply with the specifications given 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
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
FDA Technical Contacts
 John Goode
  FDA/OC/CDRH/OPEQ/OHTVI/DHTVIA/
  301-796-6407
  john.goode@fda.hhs.gov
 Michael J. Ryan
  FDA/OC/CDRH/OPEQ/ORP/
  301-796-6283
  michael.ryan@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.
-
-