There is one super set Technical Report for Graphical symbols for electrical equipment in medical practice that references a lot of different symbols standards in the normative section of the TR. It is IEC TR 60878:2023. The major sections of the TR include:
Collection 1 – General: Controls
Collection 2 – General: Movement related
Collection 3 – General: Electricity and electronics
Collection 4 – General: Light and optics
Collection 5 – General: Miscellaneous
Collection 6 – Transport, handling and packaging
Collection 7 – Safety related
Collection 8 – Safety signs
Collection 9 – Classification and identification of equipment
Collection 10 – Information and communication: Image, imaging
Collection 11 – Information and communication: Audio
Collection 12 – Information and communication: Data
Collection 13 – Patient / person
Collection 14 – Patient positioning
Collection 15 – Medical instruments and blood processing
Collection 16 – Dentistry and dentistry equipment
Collection 17 – Patient monitoring
Collection 18 – Ultrasound
Collection 19 – Lithotripsy
Collection 20 – Electrosurgery
Collection 21 – Nuclear medicine
Collection 22 – Diagnostic X-ray, CT, MR: Equipment and movement
Collection 23 – Diagnostic X-ray, CT, MR: Function
Collection 24 – Active Implantable Medical Devices
Collection 25 – Biometric and facial recognition
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Leonard (Leo) Eisner, P.E.
The "IEC 60601 Guy"
Principal Consultant, Eisner Safety Consultants
Mobile: (503) 709-8328
Email:
Leo@EisnerSafety.comWebsite:
www.EisnerSafety.com------------------------------
Original Message:
Sent: 28-Jan-2023 02:36
From: Richard Vincins
Subject: Symbol Glossary Requirements - FDA
Hello,
No, you are not and there should be a reference to standards used for symbols - which would generally be ISO 15223-1.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
Original Message:
Sent: 27-Jan-2023 13:10
From: Kevin Randall
Subject: Symbol Glossary Requirements - FDA
No, but it sounds like those IFUs are. :)
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Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2023 by ComplianceAcuity, Inc. All rights reserved.
Original Message:
Sent: 27-Jan-2023 12:41
From: Anonymous Member
Subject: Symbol Glossary Requirements - FDA
This message was posted by a user wishing to remain anonymous
From 21 CFR 801.15
(B) The term "symbols glossary" means a compiled listing of:
(1) Each SDO-established symbol used in the labeling for the device;
(2) The title and designation number of the SDO-developed standard containing the symbol;
(3) The title of the symbol and its reference number, if any, in the standard; and
(4) The meaning or explanatory text for the symbol as provided in the FDA recognition or, if FDA has not recognized the standard or portion of the standard in which the symbol is located or the symbol is not used according to the specifications for use of the symbol set forth in FDA's section 514(c) recognition, the explanatory text as provided in the standard.
I looked at several IFUs that contain Symbols Glossary and didn't see any reference to the number of the SDO developed standard, reference number
Am I missing something?