Symbols Glossary
Symbol | Standard Reference | Standard Title | Symbol Title | Explanatory text |
ISO 15223-1, Clause 5.1.1 | Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied. | Manufacturer | Indicates the medical device manufacturer. | |
ISO 15223-1, Clause 5.1.8 | Medical devices — Symbols to be used with information to be supplied by the manufacturer. | Importer | Indicates the entity importing the medical device into the locale. | |
ISO 15223-1, Clause 5.1.9 | Medical devices — Symbols to be used with information to be supplied by the manufacturer. | Distributor | Indicates the entity distributing the medical device into the locale. | |
ISO 15223-1, Clause 5.1.3 | Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied. | Date of manufacture | Indicates the date when the medical device was manufactured. | |
ISO 15223-1, Clause 5.1.6 | Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied. | Reference number | Indicates the manufacturer’s reference number so that the medical device can be identified. | |
ISO 15223-1, Clause 5.1.7 | Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied. | Serial number | Indicates the manufacturer’s serial number so that a specific medical device can be identified. | |
ISO 15223-1, Clause 5.1.5 | Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied. | Lot number | Indicates the manufacturer’s Lot code so that the batch or lot can be identified. | |
ISO 15223-1, Clause 5.1.4 | Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied. | Use by | Indicates the date after which the medical device is not to be used. | |
ISO 15223-1, Clause 5.4.3 IEC 60601-1, Table D.1, Symbol 11 |
Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied. Medical electrical equipment — Part 1: General requirements for basic safety and essential performance. |
Consult instructions for use or consult electronic instructions for use. | Indicates the need for the user to consult the instructions for use. | |
ISO 15223-1, Clause 5.3.7 | Medical devices — Symbols to be used with medical device labels, labelling and information | Storage temperature range | Indicates the temperature limits to which the medical device can be safely exposed. | |
IEC 60601-1, Table D.1, Symbol 20 | Medical electrical equipment — Part 1: General requirements for basic safety and essential performance. | Type BF applied part | To identify a type BF applied part complying with IEC 60601-1. | |
ISO 15223-1, Clause 5.4.7 | Medical devices — Symbols to be used with information to be supplied by the manufacturer. | Contains a medicinal substance | Indicates a medical device that contains or incorporates a medicinal substance. | |
ISO 15223-1, Clause 5.4.12 | Medical devices — Symbols to be used with information to be supplied by the manufacturer. | Single patient, multiple use | Indicates a medical device that may be used multiple times (multiple procedures) on a single patient. | |
ISO 15223-1, Clause 5.4.2 | Medical devices — Symbols to be used with information to be supplied by the manufacturer. | Do not reuse | Indicates a medical device that is intended for one use, or for use on a single patient during a single procedure. | |
ISO 15223-1, Clause 5.2.6 | Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied. | Do not resterilize | Indicates a medical device that is not to be resterilized. | |
ISO 15223-1, Clause 5.2.7 | Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied. | Non sterile | Indicates a medical device that has not been subjected to a sterilization process. | |
ISO 15223-1, Clause 5.2.3 | Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied. | Sterilized by ethylene oxide treatment | Indicates a medical device that has been sterilized using ethylene oxide. | |
ISO 15223-1, Clause 5.2.11 | Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied. | Single sterile barrier system | Indicates a single sterile barrier system | |
Combined symbols: ISO 15223-1, Clause 5.2.3 and ISO 15223-1, Clause 5.2.11 |
Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied. | Sterilized by ethylene oxide treatment; Single sterile barrier system | Indicates a medical device that has been sterilized using ethylene oxide. Indicates a single sterile barrier system |
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ISO 15223-1, Clause 5.6.3 | Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied. | Non-pyrogenic | Indicates a medical device that is non-pyrogenic. | |
ISO 15223-1, Clause 5.2.8 | Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied. | Do not use if package is damaged and consult instructions for use. | Indicates a medical device that should not be used if the package has been damaged or opened. | |
ISO 15223-1:2012 (Annex B, 15223-1:2012) | Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied | Not made with natural rubber latex | Not made with natural rubber latex. | |
ISO 15223-1, Clause 5.4.4 IEC 60601-1, Table D.1, Symbol 10 |
Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied. Medical electrical equipment — Part 1: General requirements for basic safety and essential performance. |
Caution: Read all warnings and precautions in instructions for use | Indicates the need for the user to consult the instructions for use for important cautionary information such as warnings and precautions that cannot, for a variety of reasons, be presented on the medical device itself. | |
IEC 60601-1-2:2007, Clause 5.1.1 | Medical electrical equipment — Part 1-2: General requirements for basic safety and essential performance — Collateral standard: Electromagnetic compatibility — Requirements and tests | Non-ionizing electromagnetic radiation | To indicate generally elevated, potentially hazardous, levels of nonionizing radiation, or to indicate equipment or systems e.g. in the medical electrical area that include RF transmitters or that intentionally apply RF electromagnetic energy for diagnosis or treatment. | |
ASTM F2503 | Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment. | Magnetic Resonance (MR) Conditional | MR Conditional under the very specific conditions provided in the labeling. No known hazards for leaving the sensor inserted in use with MR with a static magnetic field of 1.5T or 3.0T |
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ASTM F2503 | Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment. | Magnetic Resonance (MR) Unsafe | Keep away from magnetic resonance imaging (MRI) equipment. | |
EN 50419 | Marking of Electrical and Electronic Equipment in accordance with Article 11(2) of Directive 2002/96/EC (WEEE). | Recycle: Electronic Equipment | Do not dispose of this product in unsorted municipal waste stream. | |
IEC 60601-1 Edition 3 Clause 7.2.3 | Medical Electrical Equipment | Consult Accompanying Documents | Refer to instructions/ manual booklet mandatory action | |
ISO 15223, Clause 5.5.1 | Medical devices — Symbols to be used with information to be supplied by the manufacturer. | In vitro diagnostic medical device | This symbol identifies In Vitro diagnostic medical device and does not specify that the device is for “in vitro use”. | |
Symbols not from standards | ||||
21 CFR 801.15(c)(1)(i)F 21 CFR 801.109 |
Labeling-Medical devices; prominence of required label statements. Labeling-Prescription devices. |
Prescription only | Requires prescription in the United States. | |
For Eversense 365: FCC ID: 2AHYA-3402 For Eversense E3: FCC ID: 2AHYA-3401 Contains FCC ID: RYYEYSGJN |
N/A | N/A | FCC ID is assigned to all devices subject to certification | |
N/A | N/A | N/A | Universal Serial Bus (USB) |
MKT-001592 Rev 1