ISO 11318:2002

Standard Organization:

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

Recognition Date2014-01-30
Recognition List034
Recognition Number3-63
Extent Complete standard
Standards Orgs ISO International Organization for Standardization https://www.iso.org/
STG Cardiovascular
FDA Tech  Hetal Patel   FDA/OMPT/CDRH/ODE/DCD/IEDB/   240-402-6540   Hetal.Patel1@fda.hhs.gov

Rationale:

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Scope:

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.

Code of Federal Regulations:

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

FDA Guidance:

Recognized Consensus Standards

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