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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 053 Date of Entry 12/23/2019 
FR Recognition Number 8-492
Standard
ISO  5832-9 Third edition 2019-02
Implants for surgery - Metallic materials - Part 9: Wrought high nitrogen stainless steel
Scope/Abstract
This document specifies the characteristics of, and corresponding test methods for, wrought stainless steel containing a mass fraction of 0,25 % to 0,50 % nitrogen for use in the manufacture of surgical implants for which high levels of strength and corrosion resistance are required.

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

NOTE 2 Requirements for other stainless steels for implants for surgery can be found in ISO 5832-1.
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)*
Regulation Number Device Name Device Class Product Code
§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 Contact
 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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