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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 030 Date of Entry 01/25/2013 
FR Recognition Number 3-89
Standard
ISO  27186 First edition 2010-03-15
Active implantable medical devices - Four-pole connector system for implantable cardiac rhythm management devices - Dimensional and test requirements
Identical Adoption
ANSI AAMI ISO 27186:2010
Active implantable medical devices - Four-pole connector system for implantable cardiac rhythm management devices - Dimensional and test requirements
Scope/Abstract
This International Standard specifies a four-pole connector system for implantable cardiac rhythm management devices which have pacing, electrogram sensing and/or defibrillation functions. This International Standard includes requirements for the connector portion of an implantable lead as well as for the mating connector cavity attached to an implantable pulse generator. Essential dimensions and performance requirements are specified together with appropriate test methods.
This International Standard is not intended to replace or provide alternatives for unipolar or bipolar connector standards that currently exist (such as ISO 11318 and ISO 5841-3). This International Standard is not applicable to high voltage systems with intended outputs greater than 1 000 V and/or 50 A. This International Standard is not applicable to systems which include sensors or unique electrodes that are not capable of conventional pacing, electrogram sensing and/or defibrillation functions.
Extent of Recognition
Complete standard
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
N/A Implantable Pulse Generator, Pacemaker (Non-Crt) Class 3 LWP
N/A Implantable Cardioverter Defibrillator (Non-Crt) Class 3 LWS
N/A Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Class 3 NVN
N/A Permanent Defibrillator Electrodes Class 3 NVY
N/A Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode Class 3 OJX
Relevant FDA Guidance and/or Supportive Publications*
Guidance for the Submission of Research and Marketing Applications for Permanent Pacemaker Leads and for Pacemaker Lead Adaptor 510(k) Submissions, Issued November 2000.

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
 Andrew Smith
  CDRH/OPEQ/OHTII/DHTIIA/
  --
  Andrew.Smith@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
Cardiovascular
*These are provided as examples and others may be applicable.
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