Symbols

 

Symbol	Designation Number	Title	Definition per BS EN ISO 15223-1:2021
	5.1.1	Manufacturer Symbol	Indicates the official manufacturer on record for the device. Will be accompanied by the name and address of the manufacturer.
		Caution Symbol	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.
	5.4.2	Do not re-use	Indicates a medical device that is intended for one use, or for use on a single patient during a single procedure.
	5.1.6	Catalog number	Indicates the manufacturer’s catalog number so that the medical device can be identified.
	5.1.5	Batch code	Indicates the manufacturer’s batch code so that the batch or lot can be identified.
		Model Number	This symbol shall be accompanied by the model number or the part number adjacent to the symbol
	5.3.2	Sterilized using ethylene oxide	Indicates a medical device that has been sterilized using ethylene oxide.
	5.2.3	Sterilized using irradiation.	Indicates a medical device that has been sterilized using irradiation.
	5.1.4	Use-by date	Indicates the date after which the medical device is not to be used.
	5.4.3	Consult instructions for use	Indicates the need for the user to consult the instructions for use.
	EN ISO 15223-1	Keep Dry	Keep Dry
	5.3.2	Keep away from sunlight	Indicates a medical device that needs protection from light sources.
	EN ISO 15223-1	Keep away from heat and radioactive sources.	Indicates that a device needs to be kept away from light sources; this symbol can also mean “keep away from sunlight and radioactive sources”. Radioactive sources include ionizing radiation
	5.3.7	Temperature limit	Indicates the temperature limits to which the medical device can be safely exposed.
	EN ISO 15223-1	Lower Limit of Temperature	Lower limit of temperature
	EN ISO 15223-1	Upper Limit of Temperature	Upper limit of temperature
	5.2.7	Non-sterile	Indicates a medical device that has not been subjected to a sterilization process.
	5.2.6	Do not resterilize	Indicates a medical device that is not to be resterilized.
	5.2.8	Do not use if package is damaged	Indicates a medical device that should not be used if the package has been damaged or opened.
Symbol	Reference	Title	Definition Per Referenced Regulation
	21 CFR 801.109	RX Only	Caution: Federal law restricts this device to sale by or on the order of a physician or a properly licensed practitioner.
	ASTM F2502-23	MR Safe	Indicated an item poses no known hazards relating from exposure to any MR environment.
	ASTM F2502-23	MR Conditional	Indicates an item that has demonstrated safety in the MR environment within defined conditions.
	ASTM F2502-23	MR Unsafe	Indicates an item which poses unacceptable risks to the patient, medical staff or other persons within the MR environment.
	EN ISO 15223	Country of Origin / Country of Manufacture	Indicates the Country of Origin for manufacturing of the products. "CC" replaced by applicable two letter country code defined in ISO 3166-1.
	EN ISO 15223-1	Translation symbol	This symbol shall be accompanied by the name and address of the entity that is responsible for the translation activity adjacent to the symbol. Only to be used when the translation is performed by someone other than the manufacturer.
	EN ISO 15223-1	Repackaging Symbol	This symbol shall be accompanied by the name and address of the entity that is responsible for the repackaging activity adjacent to the symbol. Only to be used when the activity is performed by someone other than the manufacturer.
	EN ISO 15223-1	UDI Symbol	Optional symbol may be used if there are multiple data carriers or barcodes on the label.
	EN ISO 15223-1	Medical Device	Indicates the item is a medical device.
	ICU Medical	Quantity	Indicates the # of unit per package.
	EN ISO 15223-1	Importer	This symbol shall be accompanied by the name and address of the importing entity adjacent to the symbol.
	EN ISO 15223-1	Distributor	This symbol shall be accompanied by the name and address of the distributing entity adjacent to the symbol.
	EN ISO 15223-1	Single Sterile Barrier System	Indicates a single sterile barrier system.
	EN ISO 15223-1	Double Sterile Barrier System	Indicates two sterile barrier systems.
	EN ISO 15223-1	Single Sterile Barrier System with protective packaging inside	Indicates a single sterile barrier system with protective packaging inside.
	EN ISO 15223-1	Single Sterile Barrier System with protective packaging outside	Indicates a single sterile barrier system with protective packaging outside.
	93/42/EEC	CE Mark Including SGS Identification Number	Indicates the product conforms with the essential requirements in the European Medical Devices Directive 93/42/EEC.
	5.1.2	Authorized representative in the European Community	Indicates the Authorized representative in the European Community.