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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 041 Date of Entry 04/04/2016 
FR Recognition Number 8-405
Standard
ISO  5832-4 Third edition 2014-09-15
Implants for surgery -- Metallic materials -- Part 4: Cobalt-chromium-molybdenum casting alloy
Scope/Abstract
This part of ISO 5832 specifies the characteristics of, and corresponding test methods for, cobalt-chromium-molybdenum casting 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 might 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.
Transition Period
FDA recognition of ISO 5832-4 Third edition 2014-09-15 [Rec# 8-405] will be superseded by recognition of ISO 5832-4 Fourth edition 2024-04 [Rec# 8-619]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 8-405] until December 20, 2026. After this transition period, declarations of conformity to [Rec# 8-405] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§872.3645 Implant, Subperiosteal Class 2 ELE
§872.3940 Joint, Temporomandibular, Implant Class 3 LZD
§872.3950 Glenoid Fossa Prosthesis Class 3 MPI
§872.3960 Mandibular Condyle Prosthesis Class 3 MPL
§872.4600 Lock, Wire, And Ligature, Intraoral Class 2 DYX
§872.4760 Plate, Bone Class 2 JEY
§872.4760 Implant, Transmandibular Class 2 MDL
§872.4760 External Mandibular Fixator And/Or Distractor Class 2 MQN
§872.4880 Screw, Fixation, Intraosseous Class 2 DZL
21 CFR 888.3XXX Metallic components of all implantables
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
 John Goode
  FDA/OC/CDRH/OPEQ/OHTVI/DHTVIA/
  301-796-6407
  john.goode@fda.hhs.gov
 Andrew Steen
  FDA/OC/CDRH/OPEQ/OHTI/DHTIB/
  301-796-6284
  Andrew.Steen@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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