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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 041 Date of Entry 04/04/2016 
FR Recognition Number 5-98
Standard
ANSI ESD S20.20-2014
Standard for the Development of an Electrostatic Discharge Control Program for Protection of Electrical and Electronic Parts, Assemblies and Equipment (Excluding Electrically Initiated Explosive Devices)
Scope/Abstract
This document applies to activities that manufacture, process, assemble, install, package, label, service, test, inspect, transport or otherwise handle electrical or electronic parts, assemblies and equipment susceptible to damage by electrostatic discharges greater than or equal to 100 volts HBM. Activities that handle items that are susceptible to less than 100 volts HBM may require additional control elements or adjusted limits. Processes designed to handle items that have an ESD sensitivity less than 100 volts HBM can still claim compliance to this standard. This document does not apply to electrically initiated explosive devices, flammable liquids or powders.

PURPOSE
The purpose of this standard is to provide administrative and technical requirements for establishing, implementing and maintaining an ESD Control Program (hereafter referred to as the "Program").
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.
Relevant FDA Guidance and/or Supportive Publications*
Guidance for Industry and Food and Drug Administration Staff: Radio Frequency Wireless Technology in Medical Devices, Issued August 13, 2013

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
 Jeff Silberberg
  FDA/OC/CDRH/OSEL/DBP/
  301-796-2584
  jeffrey.silberberg@fda.hhs.gov
 Donald Witters
  FDA/OC/CDRH/OSEL/DBP/
  301-796-2483
  donald.witters@fda.hhs.gov
Standards Development Organizations
ANSI American National Standards Institute https://www.ansi.org/
ESD Electrostatic Discharge Association https://www.esda.org/
FDA Specialty Task Group (STG)
General I (QS/RM)
*These are provided as examples and others may be applicable.
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