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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 029 Date of Entry 08/20/2012 
FR Recognition Number 3-103
Standard
ISO  25539-3 First edition 2011-12-01
Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters
Identical Adoption
ANSI AAMI ISO 25539-3:2011
Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters
Scope/Abstract
ISO 25539-3:2011 specifies requirements for vena cava filters, based upon current medical knowledge. With regard to safety, it gives requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information supplied by the manufacturer. ISO 25539-3:2011 supplements ISO 14630, which specifies general requirements for the performance of non-active surgical implants.
Extent of Recognition
Complete standard
Transition Period
FDA recognition of ISO 25539-3 First edition 2011-12-01 [Rec# 3-103] will be superseded by recognition of ISO 25539-3 Second edition 2024-10 [Rec# 3-198]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 3-103] until July 4, 2027. After this transition period, declarations of conformity to [Rec# 3-103] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§870.3375 Filter, Intravascular, Cardiovascular Class 2 DTK
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
 Nathan Weidenhamer
  FDA/OC/CDRH/OPEQ/OHTII/DHTIIB/
  --
  Nathan.Weidenhamer@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
Cardiovascular
*These are provided as examples and others may be applicable.
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