Symbols Glossary

Standard: EN ISO 15223-1:2021, Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied.
Symbol	Reference Number of Symbol	Title of Symbol	Description of Symbol
	5.1.1	Manufacturer	Indicates the medical device manufacturer
	5.1.3	Date of manufacture	Indicates the date when the medical device was manufactured.
	5.1.11	Country of manufacture	To identify the country of manufacture of products
	5.1.4	Use-by date	Indicates the date after which the medical device is not to be used.
	5.1.5	Lot number	Indicates the manufacturer’s batch code so that the batch or lot can be identified.
	5.1.6	Reference number	Indicates the manufacturer’s catalogue number so that the medical device can be identified.
	5.1.7	Serial number	Indicates the manufacturer’s serial number so that a specific medical device can be identified.
	5.1.8	Importer	Indicates the entity importing the medical device into the locale.
	5.1.9	Distributor	Indicates the entity distributing the medical device into the locale.
	5.2.1	Sterile	Indicates a medical device that has been subjected to a sterilization process.
	5.2.3	Sterilized using ethylene oxide	Indicates a medical device that has been sterilized using ethylene oxide.
	5.2.4	Sterilized using irradiation	Indicates a medical device that has been sterilized using irradiation.
	5.2.6	Do not resterilize	Indicates a medical device that is not to be resterilized.
	5.2.7	Non-sterile	Indicates a medical device that has not been subjected to a sterilization process
	5.2.8	Do not use if package is damage	Indicates that 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.
	5.2.11	Single sterile barrier system	Indicates a single sterile barrier system.
	5.2.12	Double sterile barrier system	Indicates two sterile barrier systems.
	5.2.13	Single sterile barrier system with protective packaging inside	Indicates a single sterile barrier system with protective packaging inside.
	5.2.14	Single sterile barrier system with protective packaging outside	Indicates a single sterile barrier system with protective packaging outside.
	5.3.1	Fragile, handle with care	Indicates a medical device that can be broken or damaged if not handled carefully.
	5.3.2	Keep away from sunlight	Indicates a medical device that needs protection from light sources.
	5.3.4	Keep dry	Indicates a medical device that needs to be protected from moisture.
	5.3.7	Temperature limit	Indicates the temperature limits to which the medical device can be safely exposed.
	5.4.2	Do not re-use	Indicates a medical device that is intended for one single use only.
	5.4.3	Consult instructions for use or consult electronic instructions for. use.	Indicates need for the user to consult the instructions for use.
	5.4.3	Consult Instructions For Use. Available on the Surgalign website www.surgalign-wpe.adkalpha.com/eIFU/	Indicates need for the user to consult the instructions for use.
	5.4.4	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.
	5.7.2	Indicates the name of the patient	When used, the symbol shall appear adjacent to the patient name or next to a space provided to record it.
	5.7.3	Patient identification	Indicates the identification data of the patient.
	5.7.4	Patient information website	Indicates a website where a patient can obtain additional information on the medical product.
	5.7.5	Health care centre or doctor	Indicates the address of the health care centre or doctor where medical information about the patient may be found.
	5.7.6	Date	Indicates the date that information was entered or a medical procedure took place
	5.7.7	Medical device	Indicates the item is a medical device.
	5.7.10	Unique device identification	Indicates a carrier that contains unique device identifier information.

Symbol	Standard/Symbol Reference Number	Title of Symbol	Description of Symbol
	21 CFR 801.109	Prescription only	Requires prescription in the United States.
	21 CFR 801.109	Caution: Federal law restricts this device to sale by or on the order of a physician	N/A
	Regulation (EU) 2017/745 Annex V	CE Mark for Class I devices	N/A
	Regulation (EU) 2017/745 Annex V	CE Mark for Class Is, Im, Ir, IIa, IIb, III devices	N/A
	ASTM F2503	MR Conditional	Medical device that has been demonstrated to pose no known hazards in a specified MR environment with specified conditions of use.
	EN 50419 – Marking of electrical equipment in accordance with Article 11 (2) of Directive 2002/96/EC 4.1 b) 2)	Electronic Equipment: Dispose of Properly	Indicates electronic equipment to be disposed of properly.
	IEC TR 60878:2015 – Graphical symbols for electrical equipment in medical practice 5017	Protective earth	To identify an earth (ground) terminal
	ISO 7010:2011 Graphical symbols – Safety colours and safety symbols – Registered safety signs P017	No pushing	To prohibit pushing against an object
	ISO 7010:2011 Graphical symbols – Safety colours and safety symbols – Registered safety signs M002	Follow instructions for use	To signify that the instruction for use must be read