Recognized Consensus Standards: Medical Devices

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

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 Contacts

Rohini Retarekar

CDRH/OPEQ/OHTII

240-402-3750

rohini.retarekar@fda.hhs.gov

Julie Mackel

CDRH/OPEQ/OHTII/DHTIIC

301-796-2879

Julie.Mackel@fda.hhs.gov

Standards Development Organization

ISO

International Organization for Standardization