Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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053
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Date of Entry 12/23/2019
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FR Recognition Number
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5-124
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Standard | |
ISO 7000 Sixth edition 2019-07 Graphical symbols for use on equipment - Registered symbols |
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Scope/AbstractThe ISO 7000 database provides a collection of graphical symbols which are placed on equipment or parts of equipment of any kind in order to instruct the person(s) using the equipment as to its operation.
Each graphical symbol is identified by a reference number and contains a title, graphical representations in vectorized and non-vectorized formats, and some additional data as applicable, such as the function or the description of the symbol, the intended use, related symbols or publications. Various search and navigation facilities allow for easy retrieval of graphical symbols. |
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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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Public Law, CFR Citation(s) and Procode(s)*
Regulation Number |
Device Name |
Device Class |
Product Code |
21 CFR Part 660 Biologics, labeling, reporting and recordkeeping requirements. |
21 CFR Part 801 Labeling, medical devices, reporting and recordkeeping requirements. |
21 CFR Part 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. |