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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 034 Date of Entry 01/30/2014 
FR Recognition Number 8-351
Standard
ISO 5832-12 Second edition 2007-05-01
Implants for surgery - Metallic materials - Part 12: Wrought cobalt-chromium-molybdenum alloy [Including: Technical Corrigedum 1 (2008)]
Scope/Abstract
This part of ISO 5832 covers the requirements for two wrought cobalt 28-chromium 6-molybdenum alloys used for surgical implants. The properties apply specifically to wrought bar, rod and wire.

NOTE 1 The mechanical properties of a sample obtained from a finished product made of this alloy can differ from those specified in this part of ISO 5832.

NOTE 2 The high carbon content of this alloy produces a structure containing a significant carbide distribution. This can be adjusted either in the production of the bar or in subsequent thermomechanical processing to produce the final device. Carbide distribution in the final device is not included as part of this document.
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FDA recognition of ISO 5832-12 Second edition 2007-05-01 [Rec# 8-351] will be superseded by recognition of ISO 5832-12 Third edition 2019-02 [Rec# 8-500]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 8-351] until July 24, 2022. After this transition period, declarations of conformity to [Rec# 8-351] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§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
§872.3645 Implant, Subperiosteal Class 2 ELE
§872.3940 Joint, Temporomandibular, Implant Class 3 LZD
§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
§872.4880 Screw, Fixation, Intraosseous Class 2 DZL
Metallic components of all implantables
No product code information listed for §888.3XXX, Metallic components of all implantables
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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