| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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042
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Date of Entry 06/15/2016
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FR Recognition Number
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5-104
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| Standard | |
IEC /TR 60878 Ed. 3.0 b:2015
Graphical symbols for electrical equipment in medical practice |
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Scope/Abstract| 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). |
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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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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| FDA recognition of IEC /TR 60878 Ed. 3.0 b:2015 [Rec# 5-104] will be superseded by recognition of IEC /TR 60878 Ed. 4.0 2022-11 [Rec# 5-137].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. |
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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 |
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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. |
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| FDA Technical Contact
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| Standards Development Organization
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| FDA Specialty Task Group (STG)
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| *These are provided as examples and others may be applicable. |
