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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 042 Date of Entry 06/15/2016 
FR Recognition Number 5-104
IEC /TR 60878 Ed. 3.0 b:2015
Graphical symbols for electrical equipment in medical practice
This technical report provides a comprehensive compilation, for easy reference, of graphical symbols (graphics, title, description) and safety signs for medical electrical equipment. The graphical symbols are grouped in sections according to their specific field of application (see Clause 3).
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.
Transition Period
FDA recognition of IEC /TR 60878 Ed. 3.0 b:2015 [Rec# 5-104] will be superseded by recognition of IEC /TR 60878 Ed. 4.0 2022-11 [Rec# 5-137]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 5-104] until December 17, 2023. After this transition period, declarations of conformity to [Rec# 5-104] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
21 CFR 801 Labeling, medical devices, reporting and recordkeeping requirements
21 CFR 660 Biologics, labeling, reporting, and recordkeeping requirements
21 CFR 809 Labeling, medical devices
Relevant FDA Guidance and/or Supportive Publications*
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
 Scott A. Colburn
Standards Development Organization
IEC International Electrotechnical Commission http://www.iec.ch/
FDA Specialty Task Group (STG)
General I (QS/RM)
*These are provided as examples and others may be applicable.