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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.
Transition Period
FDA recognition of ISO 5832-9 Second edition 2007-06-15 [Rec# 8-150] will be superseded by recognition of ISO 5832-9 Third edition 2019-02 [Rec# 8-492]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 8-150] until July 24, 2022. After this transition period, declarations of conformity to [Rec# 8-150] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
Metallic components of all implantables
No product code information listed for §888.3XXX, Metallic components of all implantables
§872.4600 Lock, Wire, And Ligature, Intraoral Class 2 DYX
§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
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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