IFU SYMBOLS GLOSSARY

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Symbol	Title	Reference	Description
ISO 15223-1
	Manufacturer	5.1.1.	Indicates the medical device manufacturer.
	Authorized representative in the European Community	5.1.2.	Indicates the authorized representative in the European Community.
	Authorized representative in Switzerland	5.1.2.	Indicates the authorized representative in Switzerland.
	United Kingdom Responsible Person	5.1.2.	Indicates the Responsible Person in United Kingdom.
	Date of manufacture	5.1.3.	Indicates the date when the medical device was manufactured.
	Use-by date	5.1.4.	Indicates the date after which the medical device is not to be used. NOTE: Synonyms for “use-by date” are “use by”, “expiry date” and “expiration date”.
	Lot number	5.1.5.	Indicates the manufacturer’s batch code so that the batch or lot can be identified. NOTE: Synonyms for “batch code” are “lot number”, “lot code” and “batch number”.
	Catalog number	5.1.6.	Indicates the manufacturer’s catalogue number so that the medical device can be identified. NOTE: Synonyms for “catalog number” are “commercial product name”, “commercial product code”, stock keeping unit, “reference number” and “reorder number”.
	Serial number	5.1.7.	Indicates the manufacturer’s serial number so that a specific medical device can be identified.
	Importer	5.1.8.	Indicates the entity importing the medical device into the locale.
	Sterilized using ethylene oxide	5.2.3.	Indicates a medical device that has been sterilized using ethylene oxide.
	Do not use if package is damaged and consult instructions for use	5.2.8.	Indicates a medical device that should not be used if the package has been damaged or opened and that the user should consult the instructions for use for additional information. NOTE 1: This symbol can also mean “Do not use if the product sterile barrier system or its packaging is compromised”.
	Single sterile barrier system	5.2.11.	Indicates a single sterile barrier system.
	Single sterile barrier system with protective packaging inside	5.2.13.	Indicates a single sterile barrier system with protective packaging inside.
	Keep away from sunlight/Protect from heat	5.3.2	Indicates a medical device that needs protection from sunlight, other light sources, or heat.
	Keep dry	5.3.4.	Indicates a medical device that needs to be protected from moisture.
	Temperature limit	5.3.7.	Indicates the temperature limits to which the medical device can be safely exposed.
	Humidity limitation	5.3.8.	Indicates the range of humidity to which the medical device can be safely exposed.
	Atmospheric pressure limitation	5.3.9.	Indicates the range of atmospheric pressure to which the medical device can be safely exposed.
	Do not re-use	5.4.2	Indicates a medical device that is intended for one single use only.
	Consult instructions for use	5.4.3.	Indicates the need for the user to consult the instructions for use.
	Consult instructions for use or consult electronic instructions for use	5.4.3.	“Consult instructions for use” for an electronic instruction for use (eIFU) NOTE: The eIFU indicator can be a manufacturer’s website URL or some other appropriate indication that the instructions for use are available in an electronic format.
	Caution	5.4.4.	Indicates that caution is necessary when operating the device or control close to where the symbol is placed, or to indicate that the current situation needs operator awareness or operator action in order to avoid undesirable consequences.
$Does not contain or no presence of natural rubber latex$	Does not contain or no presence of natural rubber latex	5.4.5. (used with Negation Symbol as set out in IEC 80416-3:2002)	Indicates there is no presence of dry natural rubber or natural rubber latex as a material of construction within the medical device or the packaging of a medical device.
	Contains hazardous substances	5.4.10.	Indicates a medical device that contains substances that can be carcinogenic, mutagenic, reprotoxic (CMR), or substances with endocrine disrupting properties.
	Non-pyrogenic	5.6.3	Indicates a medical device that is non-pyrogenic.
	Medical device	5.7.7	Indicates the item is a medical device.
	Unique Device Identifier	5.7.10.	Indicates a carrier that contains Unique Device Identifier information.
IEC 60601-1: General Symbols
	Alternating current	Table D1, Symbol 1	To indicate on the rating plate that the equipment is suitable for alternating current only; to identify relevant terminals.
	Protective earth (ground)	Table D.1, Symbol 6	To identify any terminal which is intended for connection to an external conductor for protection against electric shock in case of a fault, or the terminal of a protective earth (ground) electrode.
	Equipotentiality	Table D.1, Symbol 8	To identify the terminals which, when connected together, bring the various parts of an equipment or of a system to the same potential, not necessarily being the earth (ground) potential, e.g. for local bonding.
	“ON” (power)	Table D.1, Symbol 12	To indicate connection to the mains, at least for mains switches or their positions, and all those cases where safety is involved.
	“OFF” (power)	Table D.1, Symbol 13	To indicate disconnection from the mains, at least for mains switches or their positions, and all those cases where safety is involved.
	Type BF applied part	Table D.1, Symbol 20	To identify a type BF applied part complying with IEC 60601-1.
	Dangerous voltage	Table D.1, Symbol 24	To indicate hazards arising from dangerous voltages.
	Stand-by	Table D.1, Symbol 29	To identify the switch or switch position by means of which part of the equipment is switched on in order to bring it into the stand-by condition, and to identify the control to shift to or to indicate the state of low power consumption.
	General warning sign	Table D.2, Symbol 2	To signify a general warning.
	Warning, electricity	Table D.2, Symbol 3	To warn of electricity..
	Refer to instruction manual/booklet	Table D.2, Symbol 10	Symbol must appear in color. Limited to Medical Electrical Equipment covered by EN 60601-1.
	Refer to instruction manual/booklet	Table D.2, Symbol 10	The eIFU indicator can be a manufacturer’s website URL or some other appropriate indication that the instructions for use are available in an electronic format.
	IP Classification, Degree of Protection	Table D.3, Symbol 2	N1 = X N2 = 0, Non-protected NOTE: When a characteristic numeral is not required to be specified, it is replaced by the letter “X.”
	IP Classification, Degree of Protection	Table D.3, Symbol 2	N1 =3, Protected against solid foreign objects of 2,5 mm ∅, N2 = 1, Protection against vertically falling water drops
IEC 60417 Graphical Symbols for Use on Equipment
	Fuse	IEC 60417-5016	Identifies fuse boxes or their location.
	Input	IEC 60417-5034	To identify an input terminal when it is necessary to distinguish between inputs and outputs.
	Output	IEC 60417-5035	To identify an output terminal when it is necessary to distinguish between inputs and outputs.
	Non-ionizing electromagnetic radiation	IEC 60417:2002 -5140	Indicates potentially hazardous, levels of ionizing radiation or indicate equipment in the electrical area that include RF transmitters or that intentionally apply RF electromagnetic energy for diagnosis or treatment.
Additional symbols
	MR Unsafe	ASTM F2503, 7.3.3 Table 1	An item which poses unacceptable risks to the patient, medical staff or other persons within the MR environment.
	Warning: Radioactive material or ionizing radiation	ISO 7010-W003	To warn of radioactive materials or ionizing radiation.
	Crossed-out Wheeled Bin	ISO EN 50419	Marking of EEE (electrical and electronic equipment). Follow local requirements for proper disposal.
	Crossed-out Wheeled Bin	ISO EN 50419	Batteries in this product should not be disposed as unsorted municipal waste and should instead be disposed separately.
	Brakes/Door Unlocked	Bracco (custom)	Brakes are Unlocked or Door is Unlocked.
	Brakes/Door Locked	Bracco (custom)	Brakes are Locked or Door is Locked.
	Prescription Use Only	CFR 21 801 .109 (US FDA)	CAUTION: Federal law (USA) restricts this device to sale, distribution, and use by, or on the order of, a physician.
	Intertek conformity mark	Intertek testing mark	With respect to electric shock, fire, mechanical and other specified hazards, only in accordance with AAMI/ ANSI ES60601-1:2005.
	UL Classified Mark for the United States and Canada	UL certification requirements	UL Classified Mark for the United States and Canada.
	European Conformity mark	MDR EU 217/745	European Conformity.
	UK Conformity Assessed	UK Medical Devices Regulations (UK MDR 2002, as amended)	United Kingdom Conformity Mark.