Symbol
Title
Definition
Reference
Manufacturer
Indicates the medical device manufacturer.
ISO 15223-1, 5.1.1
ISO 7000, 3082
Authorized Representative in the European Community / European Union
Indicates the Authorized Representative in the European Community / European Union.
ISO 15223-1, 5.1.2
Swiss Authorized Representative
Indicates the Authorized Representative in Switzerland.
Swissmedic
Importer
Indicates the entity importing the medical device into the locale.
ISO 15223-1, 5.1.8
ISO 7000, 3725
Date of manufacture
Indicates the date when the medical device was manufactured.
ISO 15223-1, 5.1.3
ISO 7000, 2497
Use-by date (expiration date)
Indicates the date after which the medical device is not to be used.
ISO 15223-1, 5.1.4
ISO 7000, 2607
Batch Code
Indicates the manufacturer's batch code so that the batch or lot can be identified.
ISO 15223-1, 5.1.5
ISO 7000, 2492
Catalogue Number
Indicates the manufacturer's catalogue number so that the medical device can be identified.
ISO 15223-1, 5.1.6
ISO 7000, 2493
Serial number
Indicates the manufacturer's serial number so that a specific medical device can be identified.
ISO 15223-1, 5.1.7
ISO 7000, 2498
Medical Device
Indicates that the item is a medical device.
ISO 15223-1, 5.7.7
Prescription only (USA only)
Indicates that the medical device requires a prescription in the United States.
21 CFR 801.15(c)
21 CFR 801.109
CE marking
Indicates that the item is in conformity with applicable European Union regulations and legislation.
EU MDR 2017/745 Article 20, Annex V
Do not re-use
Indicates a medical device that is intended for one single use only.
ISO 15223-1, 5.4.2
ISO 7000, 1051
Follow instructions for use
Refer to instruction manual/booklet.
ISO 7010, M002
Consult instructions for use
Indicates the need for the user to consult the instructions for use.
ISO 15223-1, 5.4.3
ISO 7000, 1641
Caution
Indicates that caution is necessary when operating the device or control close to where the symbol is placed, or that the current situation needs operator awareness or operator action in order to avoid undesirable consequences.
ISO 15223-1, 5.4.4
ISO 7000, 0434A
Do not use if package is damaged
Indicates a medical device that should not be used if the package has been damaged or opened.
ISO 15223-1, 5.2.8
ISO 7000, 2606
Keep dry
Indicates a medical device that needs to be protected from moisture.
ISO 15223-1, 5.3.4
ISO 7000, 0626
Temperature Limit
Indicates the temperature limits to which the medical device can be safely exposed.
ISO 15223-1, 5.3.7
ISO 7000, 0632
Humidity Limitation
Indicates the range of humidity to which the medical device can be safely exposed.
ISO 15223-1, 5.3.8
ISO 7000, 2620
Atmospheric Pressure Limitation
Indicates the range of atmospheric pressure to which the medical device can be safely exposed.
ISO 15223-1, 5.3.9
ISO 7000, 2621
Non-ionizing electromagnetic radiation
To indicate generally elevated, potentially hazardous, levels of non-ionizing 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.
ISO 60417, 5140
Type BF Applied Part
To identify a Type BF applied part complying with IEC 60601-1.
ISO 60417, 5333
Waste Electrical and Electronic Equipment (WEEE)
Indicates that the product should not be discarded as unsorted waste but must be sent to separate collection facilities for recovery and recycling of electrical/electronic waste.
EN 50419
General symbol for recovery/recyclable
To indicate that the marked item or its material is part of a recovery or recycling process.
ISO 7000, 1135
Degree of Ingress Protection Provided by Enclosure
Protected against solid foreign objects of 12.5mm and greater. Protection against vertically falling water drops when enclosure tilted up to 15 degrees.
IEC 60529
No Latex
Not made with natural rubber latex.
N/A
Adults Only
Indicates that the device is to be use by adults 18+ only.
N/A
Charge between uses
Indicates that the device must be re-charged between uses.
N/A
"ON"/"OFF" (push-push)
To indicate connection to or disconnection from the mains, at least for mains switches or their positions, and all those cases where safety is involved.
Each position, “ON” or “OFF”, is a stable position.
IEC 60417, 5010
Direct current
To indicate on the rating plate that the equipment is suitable for direct current only; to identify relevant terminals.
IEC 60417, 5031
Giteki Mark (Japan Technical Conformity Mark)
Indicates that the equipment conforms to the technical regulations specified in the Radio Law.
Japan Radio Law, Article 38
FCC Mark
Indicates that the equipment complies with radio communication and electromagnetic radiation requirements in the United States.
47 CFR Part 15
