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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 020 Date of Entry 09/09/2008 
FR Recognition Number 8-61
Standard
ISO 5832-6:1997
Implants for surgery -- Metallic materials -- Part 6: Wrought cobalt-nickel-chromium-molybdenum alloy
Scope/Abstract
This part of ISO 5832 specifies the characteristics of, and corresponding test methods for, wrought cobalt-nickel-chromium-molybdenum 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.
Transition Period
FDA recognition of ISO 5832-6:1997 [Rec# 8-61] will be superseded by recognition of ISO 5832-6 Third Edition 2022-03 [Rec# 5-594]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 8-61] until December 17, 2023. After this transition period, declarations of conformity to [Rec# 8-61] will not be accepted.
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
§872.3950 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
§872.3645 Implant, Subperiosteal Class 2 ELE
§872.3940 Joint, Temporomandibular, Implant Class 3 LZD
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
 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.
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