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 5.1.2	Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied.	Authorized representative in the European Community/European Union	Indicates the authorizedrepresentative in the European Community/European Union
	MU600_00_016 version 6.0: Section 6	Swiss Medic: Obligations Economic Operators CH MU600_00_016 version 6.0	Authorized representative in the Switzerland	Indicates the authorized representative in the Switzerland
	EU MDR 2017/745 Annex V	Regulation (EU) 2017/745	Conformité Européenne	Devices bearing this mark shows it is in conformity with Regulation (EU) 2017/745
	ISO 15223-1, Clause 5.7.7	Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied.	Medical Device	Indicates the item is a medical device
	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.
	IEC 60601-1 Edition 3 Clause 7.2.3	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 5.7.3	Medical devices – Symbols to be used with information to be supplied by the manufacturer.	Patient identification	Indicates the identification data of the patient
	ISO 15223-1, Clause 5.1.2	Medical devices – Symbols to be used with information to be supplied by the manufacturer.	Health care centre or doctor	Indicates the address of the health care centre or doctor where medical information about the patient may be found
	ISO 15223-1, Clause 5.7.10	Medical devices – Symbols to be used with information to be supplied by the manufacturer.	Unique device identifier	Indicates a carrier that contains unique device identifier information
	ISO 15223-1, Clause 5.7.4	Medical devices – Symbols to be used with information to be supplied by the manufacturer.	Patient information website	Indicates a website where a patient can obtain additional information on the medical product
	ISO 15223-1, Clause 5.7.6	Medical devices – Symbols to be used with information to be supplied by the manufacturer.	Date	Indicates the date that information was entered or a medical procedure took place
	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 5.2.3	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
	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
	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.
	Royal Decree 1055/2022 Article 13	Royal Decree 1055/2022	Recycling Symbol: Plastic, Metal, and Composite Spain Only	Check local disposal requirements
	Royal Decree 1055/2022 Article 13	Royal Decree 1055/2022	Recycling Symbol: Paper and Cardboard Packaging Spain Only	Check local disposal requirements
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.
	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)
	N/A	N/A	Recyling Symbol	Check local disposal requirements

MKT-001604 Rev 1

MKT-001605 Rev 1

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