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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 046 Date of Entry 12/23/2016 
FR Recognition Number 19-20
IEEE ANSI  C63.16-2016 (Revision of ANSI C63.16-1993)
American National Standard Guide for Electrostatic Discharge Test Methodologies and Acceptance Criteria for Electronic Equipment
This guide provides electrostatic discharge (ESD) test considerations that a manufacturer should use in assessing the expected ESD effects on products in a wide range of environments and customer use. The focus is well beyond that used to simply show that a product complies with a local, regional, or international standard or regulation. The following are included: charged peripheral testing, connector pin testing, and details on the use of ESD simulators. Finally, suggestions for assuring the safety of those who apply the ESD discharge are provided. The annexes include information on test method selection and more background on air and contact discharge for those who want to further understand the differences in these methods.

This guide is not applicable to manufacturing, service, or maintenance of equipment. Personnel who perform these activities should be trained to avoid ESD effects or damage to the equipment.

In summary, this guide has test techniques beyond those that are commonly used (e.g., IEC 61000-4-2), and hence it can be a significant tool for increasing the immunity of products to ESD events
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: Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices,Issued July 11, 2016

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
 Donald Witters
Standards Development Organizations
IEEE Institute of Electrical and Electronic Engineers https://www.ieee.org/
ANSI American National Standards Institute https://www.ansi.org/
FDA Specialty Task Group (STG)
General II (ES/EMC)
*These are provided as examples and others may be applicable.