• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Recognized Consensus Standards

  • 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 031 Date of Entry 08/06/2013 
FR Recognition Number 8-336
Standard
ASTM F562-13
Standard Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical Implant Applications (UNS R30035)
Scope/Abstract
1.1 This specification covers requirements of wrought 35cobalt-35nickel-20chromium-10molybdenum alloy (UNS R30035) in the form of bar and wire, used for the manufacture of surgical implants. This alloy depends on combinations of work strengthening and aging to attain a variety of combinations of strength and ductility.
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FDA recognition of ASTM F562-13 [Rec# 8-336] will be superseded by recognition of ASTM F562-22 [Rec# 8-583]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 8-336] until July 9, 2023. After this transition period, declarations of conformity to [Rec# 8-336] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Implantable Medical Devices
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
 David M. Saylor
  FDA/OC/CDRH/OSEL/DBCMS/
  301-796-2626
  david.saylor@fda.hhs.gov
 Michael J. Ryan
  FDA/OC/CDRH/OPEQ/ORP/
  301-796-6283
  michael.ryan@fda.hhs.gov
Standards Development Organization
ASTM ASTM International http://www.astm.org/
FDA Specialty Task Group (STG)
Materials
*These are provided as examples and others may be applicable.
-
-