Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 063 Date of Entry 12/23/2024 
FR Recognition Number 8-621
Standard
ISO  5832-1 Sixth edition 2024-04
Implants for surgery - Metallic materials - Part 1: Wrought stainless steel
Scope/Abstract
This document specifies the characteristics of, and corresponding test methods for, wrought stainless steel for use in the manufacture of surgical implants.
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 The alloy described in this document corresponds to UNS S31673 in ASTM F138 and ASTM F139.
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FDA recognition of ISO 5832-1 Fifth edition 2016-07-15 [Rec# 8-435] will be superseded by recognition of ISO 5832-1 Sixth edition 2024-04 [Rec# 8-621]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 8-435] until December 20, 2026. After this transition period, declarations of conformity to [Rec# 8-435] will not be accepted.
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 Contacts
 John Goode
  FDA/OC/CDRH/OPEQ/OHTVI/DHTVIA/
  301-796-6407
  john.goode@fda.hhs.gov
 Lauren Giles
  FDA/OC/CDRH/OPEQ/OHTI/DHTIB/
  301-796-9552
  Lauren.Giles@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.
-
-