ISO 14708-3 Implants for Surgery-Active Implantable Medical Devices-Part 3: Implantable Neurostimulators

Speaker

Instructor: Mike Colvin
Product ID: 705772
Training Level: Basic to Intermediate

Location
  • Duration: 90 Min
In this webinar our expert Dr. Mike Colvin will discuss how to use ISO 14708-3 standard which is applicable to active implantable medical devices intended for electrical stimulation of the central or peripheral nervous system and contains particular requirements to ensure basic assurance of safety for both patients and users.
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Why Should You Attend:

ISO 14708-3 is applicable to active implantable medical devices intended for electrical stimulation of the central or peripheral nervous system also known as neurostimulators. They produce controlled electrical pulses that are delivered through electrodes in contact with a specific target area.

The standard testing is to be carried out on a sample of a device to assess device behavioral responses, and are not intended to be used for the routine testing of manufactured products. The standard provides basic assurance of safety for both patients and users.

The objective of the Webinar is to teach participants how to use ISO 14708-3. The ISO 14708 standard specifies particular requirements for active implantable medical devices intended for electrical stimulation of the central or peripheral nervous system, to provide basic assurance of safety for both patients and users.

Areas Covered in the Webinar:

The webinar will cover the following topics:

  • Unintentional biological effects being caused by the active implantable medical device.
  • Harm to the patient or user caused by external physical features of the active implantable medical device.
  • Harm to the patient caused by electricity.
  • Harm to the patient caused by heat.
  • Ionizing radiation released or emitted from the active implantable medical device.
  • Unintended effects caused by the active implantable medical device
  • Damage caused by external defibrillators.
  • Changes caused by electrical Fields applied directly to the patient.
  • Changes caused by miscellaneous medical treatments.
  • Mechanical forces.
  • Damage caused by electrostatic discharge.
  • Damage caused by atmospheric pressure changes.
  • Damage caused by temperature changes.
  • Electromagnetic non-ionizing radiation.

Who Will Benefit:

Anyone with a desire to be up to date with the current state of the art of implantable neurostimulators from Medical device, pharmaceutical, and combination product start up and established companies.

Instructor Profile:
Mike Colvin

Mike Colvin
Medical Device Technical Adviser/Consultant

Dr. Mike Colvin has over 30 years direct experience in managing Biocompatibility assessment and testing, working in the medical device and combination products field. He has worked on/contributed to many domestic and international Biocompatibility committees, and has been a consultant to the medical device industry on the proper Biocompatibility strategies for success.

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