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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 041 Date of Entry 04/04/2016 
FR Recognition Number 3-125
Standard
ISO  5841-3 Third edition 2013-04-15
Implants for surgery - Cardiac pacemakers - Part 3: Low-profile connectors [IS-I] for implantable pacemakers
Scope/Abstract
ISO 5841-3:2013 specifies a connector assembly to be used to connect implantable pacemaker leads to implantable pacemaker pulse generators. Essential dimensions and performance requirements related to connector fit are specified, together with appropriate test methods.

ISO 5841-3:2013 is applicable only to the form and fit of the connector assembly.

ISO 5841-3:2013 supplements ISO 14708‑2 only for those pacemaker components which are claimed by their labelling to be fitted with an IS-1 connector assembly part.
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
§870.3680 Permanent Pacemaker Electrode Class 3 DTB
§870.3680 Electrode, Pacemaker, Temporary Class 2 LDF
§870.3680 Electrode, Pacing And Cardioversion, Temporary, Epicardial Class 2 NHW
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
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 Contacts
 Robert T. Kazmierski
  FDA/OC/CDRH/OPEQ/OHTII/DHTIIA/
  301-796-5447
  Robert.Kazmierski@fda.hhs.gov
 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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