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U.S. Department of Health and Human Services

Recognized Consensus Standards
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 049 Date of Entry 06/07/2018 
FR Recognition Number 17-15
Standard
ISO 14708-3 Second edition 2017-04
Implants for surgery - Active implantable medical devices - Part 3: Implantable neurostimulators
Scope/Abstract
ISO 14708-3:2017 is applicable to active implantable medical devices intended for electrical stimulation of the central or peripheral nervous system.

The tests that are specified in this document are type tests and are to be carried out on a sample of a device to assess device behavioural responses, and are not intended to be used for the routine testing of manufactured products.
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§882.5820 Implanted Cerebellar Stimulator Class 3 GZA
§882.5830 Implanted Diaphragmatic/Phrenic Nerve Stimulator Class 3 GZE
§882.5840 Stimulator, Intracerebral/Subcortical, Implanted Class 3 GYZ
§882.5850 Stimulator, Spinal-Cord, Implanted, For Bladder Evacuation Class 3 GZD
§882.5860 Stimulator, Neuromuscular, Implanted Class 3 GZC
§882.5880 Stimulator, Spinal-Cord, Implanted (Pain Relief) Class 2 GZB
§876.5270 Stimulator, Electrical, Implantable, For Incontinence Class 3 EZW
Unclassified Deep Brain Stimulator For Obsessive Compulsive Disorder (Ocd) Class f OLM
Unclassified Implanted Subcortical Electrical Stimulator (Motor Disorders) Class f MRU
Unclassified Stimulator, Autonomic Nerve, Implanted (Depression) Class 3 MUZ
Unclassified Stimulator, Electrical, Implanted, For Parkinsonian Tremor Class 3 MHY
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 Contact
 Kristen Bowsher
  FDA/OC/CDRH/OPEQ/OHTV/DHTVB/
  301-796-6448
  kristen.bowsher@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
Neurology
*These are provided as examples and others may be applicable.
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