| Part B: Supplementary Information Sheet (SIS) |
|
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
|
5-102
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| Standard | |
IEC 60417:2002 DB
Graphical symbols for use on equipment |
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Scope/AbstractIEC 60417 graphical symbols are primarily intended to:
- identify the equipment or a part of the equipment (e.g. a control or display);
- indicate a functional state (e.g. on, off, alarm);
- designate connections (e.g. terminals, filling points for materials);
- provide information on packaging (e.g. identification of contents, instructions for handling);
- provide instruction for the operation of the equipment (e.g. limitations of use).
IEC 60417 does not apply to symbol originals for:
- safety signs;
- use on drawings and diagrams;
- use in technical documentation of products and in technical product documentation; |
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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. |
|
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
|
| 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. |
