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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 034 Date of Entry 01/30/2014 
FR Recognition Number 8-159
Standard
ISO  9584 First edition 1993-10-15
Implants for surgery -- Non-destructive testing -- Radiographic examination of cast metallic surgical implants
Scope/Abstract
This International Standard establishes a method for detecting and evaluating internal imperfections of cast metallic surgical implants.

Guidance on the acceptance limits for internal imperfections in cast metallic surgical implants is given in annex A.
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FDA recognition of ISO 9584 First edition 1993-10-15 [Rec# 8-159] will be superseded by recognition of ISO 9584 Second edition 2023-10 [Rec# 8-611]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 8-159] until July 05, 2026. After this transition period, declarations of conformity to [Rec# 8-159] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
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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