90.60 Close of review Mar 4, 2024
ISO
ISO/TC 150/SC 6 Active implants
International Standard
11.040.40 Implants for surgery, prosthetics and orthotics
Published
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.
PUBLISHED
ISO 11318:2002
90.60
Close of review
Mar 4, 2024