Symbols Glossary Definition

Symbols Derived from Standards

Symbol	Standard Reference	Standard Title	Symbol Title	Explanatory Text
	ASTM  F2503-20	Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment	MR Safe	An item which poses no known health hazards from exposure to any MR environment.
	ASTM F2503-20	Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment	MR Conditional	An item with demonstrated safety in the MR environment within defined conditions.
	ISO 15223-1, Reference 5.1.1	Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements.	Manufacturer	Indicates the medical device manufacturer.
	ISO 15223-1, Reference 5.1.2	Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements.	Authorized representative in the European Community	Indicates the Authorized representative in the European Community.
	ISO 15223-1, Reference 5.1.3	Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements.	Date of manufacture	Indicates the date when the medical device was manufactured.
	ISO 15223-1, Reference 5.1.4	Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements.	Use-by date	Indicates the date after which the medical device is not to be used.
	ISO 15223-1, Reference 5.1.5	Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements.	Batch code	Indicates the manufacturer's batch code so that the batch or lot can be identified.
	ISO 15223-1, Reference 5.1.6	Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements.	Catalogue number	Indicates the manufacturer's catalogue number so that the medical device can be identified.
	ISO 15223-1, Reference 5.1.7	Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements.	Serial number	Indicates the manufacturer's serial number so that a specific medical device can be identified.
	ISO 15223-1, Reference 5.2.1	Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements.	Sterile	Indicates a medical device that has been subjected to a sterilization process.
	ISO 15223-1, Reference 5.2.3	Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements.	Sterilized using ethylene oxide	Indicates a medical device that has been sterilized using ethylene oxide.
	ISO 15223-1, Reference 5.2.4	Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements.	Sterilized using irradiation	Indicates a medical device that has been sterilized using irradiation.
	ISO 15223-1, Reference 5.2.6	Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements.	Do not resterilize	Indicates a medical device that is not to be resterilized.
	ISO 15223-1, Reference 5.2.7	Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements.	Non-sterile	Indicates a medical device that has not been subjected to a sterilization process.
	ISO 15223-1, Reference 5.2.8	Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements.	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, Reference 5.3.2	Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements.	Keep away from sunlight	Indicates a medical device that needs protection from light sources.
	ISO 15223-1, Reference 5.3.5	Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements.	Lower limit of temperature	Indicates the lower limit of temperature to which the medical device can be safely exposed.
	ISO 15223-1, Reference 5.3.6	Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements.	Upper limit of temperature	Indicates the upper limit of temperature to which the medical device can be safely exposed.
	ISO 15223-1, Reference 5.3.7	Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements.	Temperature limit	Indicates the temperature limits to which the medical device can be safely exposed.
	ISO 15223-1, Reference 5.4.2	Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements.	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, Reference 5.4.3	Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements.	Consult instructions for use	Indicates the need for the user to consult the instructions for use.
	ISO 15223-1, Reference 5.4.3	Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements.	Consult electronic instructions for use	Indicates the need for the user to consult the electronic instructions for use (eIFU) at the specified website location.
	ISO 15223-1, Reference 5.4.4	Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements.	Caution	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.
	ISO 15223-1, Reference 5.4.5	Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements.	Contains or presence of natural rubber latex	Indicates the presence of natural rubber or dry natural rubber latex as a material of construction within the medical device or the packaging of a medical device.
	ISO 15223-1, Reference 5.4.12	Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements.	Single patient - multiple use	Indicates a medical device that may be used multiple times (multiple procedures) on a single patient.
	ISO 15223-1, Reference 5.7.1	Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements.	Patient number	Indicates a unique number associated with an individual patient.
	ISO 7010, Reference W021	Graphical symbols — Safety colours and safety signs — Registered safety signs	Warning; Flammable material	To warn of flammable material.
	ISO 7010, Reference W023	Graphical symbols — Safety colours and safety signs — Registered safety signs	Warning; Corrosive substance	To warn of corrosive substance.

Symbols Not Derived from Standards

Symbol	Standard Reference	Standard Title	Symbol Title	Explanatory Text
Rx Only	21 CFR 801.109	Labeling; Prescription devices	Prescription use only	Caution: Federal law (USA) restricts this device to sale by or on the order of a licensed healthcare practitioner.
	MDD 93/42/EEC Annex II; MDR 2017/745 Annex V	The requirements for accreditation and market surveillance relating to the marketing of products; Medical Device Directive and Medical Device Regulation.	European conformity	European conformity (CE) mark for Class I medical devices.
	MDD 93/42/EEC Annex II; MDR 2017/745 Annex V	The requirements for accreditation and market surveillance relating to the marketing of products; Medical Device Directive and Medical Device Regulation.	European conformity	European conformity (CE) mark with Notified Body identification number for Class Im, Ir, Is, IIa, IIb, III medical devices Notified Body No. 0086: BSI, United Kingdom
	MDD 93/42/EEC Annex II; MDR 2017/745 Annex V	The requirements for accreditation and market surveillance relating to the marketing of products; Medical Device Directive and Medical Device Regulation.	European conformity	European conformity (CE) mark with Notified Body identification number for Class Im, Ir, Is, IIa, IIb, III medical devices Notified Body No. 2797: BSI, Netherlands
	MDR 2017/745 Annex 1 23.2(q)	The requirements for indicating that a device is a medical device; Medical Device Regulation.	Medical device	Indicates that the device is a medical device.
	N/A	N/A	Telephone receiver or handset	Indicates the telephone contact number.
	Medicines and Medical Device Act 2021	Part 4, Chapter 1, Section 16 (1) (f)	UKCA marking	Signifies Great Britain technical conformity.