Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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041
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Date of Entry 04/04/2016
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FR Recognition Number
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5-98
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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) |
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Scope/AbstractThis 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"). |
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Extent of Recognition
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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. |
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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. |
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FDA Technical Contacts
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Standards Development Organizations
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FDA Specialty Task Group (STG)
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*These are provided as examples and others may be applicable. |