Recognized Consensus Standards: Medical Devices

Part B: Supplementary Information Sheet (SIS)

FR Recognition List Number

034

Date of Entry 01/30/2014

FR Recognition Number

3-63

Standard

ISO 11318:2002
Cardiac Defibrillators -- Connector assembly DF-1 for implantable defibrillators - Dimensions and test requirements.

Scope/Abstract

This International Standard specifies a unipolar connector assembly, DF-1, intended for use in connecting implantable defibrillator leads to implantable defibrillator generators that do not produce more than 1 kV/50 A peak output. Essential dimensions and performance requirements related to connector fit are specified, along with test methods. This International Standard does not specify other connector features such as fastening means and material. This International Standard is applicable to the form and fit of the connector assembly, and does not address all aspects of functional compatibility, system performance, or reliability of different implantable defibrillator leads and implantable defibrillator generator assemblies.

Extent of Recognition

Complete standard

Public Law, CFR Citation(s) and Procode(s)*

Regulation Number	Device Name	Device Class	Product Code
N/A	Implantable Cardioverter Defibrillator (Non-Crt)	Class 3	LWS
N/A	Defibrillator, Implantable, Dual-Chamber	Class 3	MRM

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

Hetal Patel

FDA/OC/CDRH/OPEQ/OHTII/DHTIIA/

240-402-6540

Hetal.Odobasic@FDA.HHS.GOV

Andrew Smith

CDRH/OPEQ/OHTII/DHTIIA/

Andrew.Smith@fda.hhs.gov

Luke Ralston

FDA/CDRH/OPEQ/OHTII/

301-796-6362

Luke.Ralston@fda.hhs.gov