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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 031 Date of Entry 08/06/2013 
FR Recognition Number 8-343
Standard
ASTM F899-12b
Standard Specification for Wrought Stainless Steels for Surgical Instruments
Scope/Abstract
1.1 This specification covers the chemistry requirements for wrought stainless steels used for the manufacture of surgical instruments. The data contained in Tables 1-4 of this specification, including typical hardness values, common heat treating cycles, and examples of selected stainless steels that have been used for surgical instruments, is provided for reference only. Mechanical property requirements, heat treating requirements, hardness requirements and all other requirements except chemistry are governed by the appropriate material standards as referenced below or as agreed upon between the purchaser and supplier.
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FDA recognition of ASTM F899-12b [Rec# 8-343] will be superseded by recognition of ASTM F899-20 [Rec# 8-527]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 8-343] until July 9, 2023. After this transition period, declarations of conformity to [Rec# 8-343] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Surgical Instruments
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
 David M. Saylor
  FDA/OC/CDRH/OSEL/DBCMS/
  301-796-2626
  david.saylor@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.
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