Symbol Glossary Definitions


SYMBOL STANDARD REFERENCE STANDARD TITLE SYMBOL TITLE EXPLANATORY TEXT
Manufacturer EN 980, Clause 5.12 Symbols for use in the labelling of medical devices. Manufacturer Indicates the medical device manufacturer.
ISO 15223-1, Clause 5.1.1 Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied.
ISO 7000-3082 Graphical symbols for use on equipment.
Date of manufacture EN 980, Clause 5.6 Symbols for use in the labelling of medical devices. Date of manufacture Indicates the date when the medical device was manufactured.
ISO 15223-1, Clause 5.1.3 Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied.
ISO 7000-2497 Graphical symbols for use on equipment.
Country of origin EN 60417-6049 Graphical symbols for use on equipment. Country of origin To identify the country of manufacture of products.
ISO 3166-1 Codes for the representation of names of countries and their subdivisions — Part 1:Country codes.
Authorized European representative EN 980, Clause 5.13 Symbols for use in the labelling of medical devices. Authorized European representative Indicates the Authorized representative in the European Community.
ISO 15223-1, Clause 5.1.2 Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied.
Catalogue or model number EN 980, Clause 5.10 Symbols for use in the labelling of medical devices. Catalogue or model number Indicates the manufacturer's catalogue number so that the medical device can be identified.
ISO 15223-1, Clause 5.1.6 Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied.
ISO 7000- 2493 Graphical symbols for use on equipment.
Serial number EN 980, Clause 5.5 Symbols for use in the labelling of medical devices. Serial number Indicates the manufacturer's serial number so that a specific 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.
ISO 7000-2498 Graphical symbols for use on equipment.
Batch code EN 980, Clause 5.4 Symbols for use in the labelling of medical devices. Batch code Indicates the manufacturer's batch code so that the batch or lot 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.
ISO 7000-2492 Graphical symbols for use on equipment.
Use by EN 980, Clause 5.3 Symbols for use in the labelling of medical devices. Use by Indicates the date after which the medical device is not to be used.
ISO 15223-1, Clause 5.1.4 Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied.
ISO 7000-2607 Graphical symbols for use on equipment.
In vitro diagnostic medical device EN 980, Clause 5.16 Symbols for use in the labelling of medical devices. In vitro diagnostic medical device Indicates a medical device that is intended to be used as an in vitro diagnostic medical device.
ISO 15223-1, Clause 5.5.1 Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied.
Follow instructions for use IEC 60601-1, Table D.2, Symbol 10 Medical electrical equipment — Part 1: General requirements for basic safety and essential performance. Follow instructions for use Refer to instruction manual/booklet.
Consult instructions for use EN 980, Clause 5.18 Symbols for use in the labelling of medical devices. Consult instructions for use Indicates the need for the user to consult the instructions for use.
ISO 15223-1, Clause 5.4.3 Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied.
IEC 60601-1, Table D.1, Symbol 11 Medical electrical equipment — Part 1: General requirements for basic safety and essential performance.
ISO 7000-1641 Graphical symbols for use on equipment.
Attention: Read all warnings and precautions in instructions for use EN 980, Clause 5.11 Symbols for use in the labelling of medical devices. Attention: 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.
ISO 15223-1, Clause 5.4.4 Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied.
IEC 60601-1, Table D.1, Symbol 10 Medical electrical equipment — Part 1: General requirements for basic safety and essential performance.
ISO 7000-0434 Graphical symbols for use on equipment.
Non-ionizing electromagnetic radiation 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.
IEC 60417-5140 Graphical symbols for use on equipment.
IEC 60878-5140 Graphical symbols for electrical equipment in medical practice.
Storage humidity range ISO 15223-1, Clause 5.3.8 Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied. Storage humidity range Indicates the range of humidity to which the medical device can be safely exposed.
ISO 7000-2620 Graphical symbols for use on equipment.
Storage temperature range EN 980, Clause 5.17.3 Symbols for use in the labelling of medical devices. Storage temperature range Indicates the temperature limits to which the medical device can be safely exposed.
ISO 15223-1, Clause 5.3.7 Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied.
ISO 7000-0632 Graphical symbols for use on equipment
Atmospheric Pressure ISO 15223-1, Clause 5.3.9 Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied. Atmospheric Pressure Indicates the range of atmospheric pressure to which the medical device can be safely exposed.
ISO 7000-2621 Graphical symbols on equipment
Magnetic Resonance (MR) unsafe 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.
Keep dry EN 980, Clause 5.21 Symbols for use in the labelling of medical devices. Keep dry Indicates a medical device that needs to be protected from moisture.
ISO 15223-1, Clause 5.3.4 Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied.
ISO 7000-0626 Graphical symbols for use on equipment.
Fragile, handle with care ISO 15223-1, Clause 5.3.1 Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied. Fragile, handle with care Indicates a medical device that can be broken or damaged if not handled carefully.
ISO 7000-0621 Graphical symbols for use on equipment.
Type BF applied part IEC 60601-1, Table D.1, Symbol 20 Medical electrical equipment — Type BF applied part To identify a type BF applied part complying with IEC 60601-1.
IEC 60417- 5333 Part 1: General requirements for basic safety and essential performance.
Type B applied part IEC 60601-1, Table D.1, Symbol 19 Medical electrical equipment — Part 1: General requirements for basic safety and essential performance. Type B applied part To identify a type B applied part complying with IEC 60601-1.
IEC 60417-5840 Graphical symbols for use on equipment.
Degree of Ingress Protection Provided by Enclosure IEC 60601-1, Table D.3, Symbol 2

IEC 60529
Medical electrical equipment — Part 1: General requirements for basic safety and essential performance.


Degrees of Protection Provided by Enclosures (IP Code).
Degree of Ingress Protection Provided by Enclosure Manufacturer-determined degree of particle and water ingress protection, where...



N1= degree of protection from particulates (scale of 0-6); and



N2 = degree of protection from water (scale of 0-8)



NOTE When a characteristic numeral is not required to be specified, it is replaced by the letter ÒXÓ.
Degree of Ingress Protection Provided by Enclosure Protected against solid foreign objects of 12. 5 mm and greater, and against the effects of continuous immersion in water.
Degree of Ingress Protection Provided by Enclosure Protected against solid foreign objects of 1.0 mm and greater, and against the effects of continuous immersion in water.
Degree of Ingress Protection Provided by Enclosure Protected against the effects of continuous immersion in water.
Degree of Ingress Protection Provided by Enclosure Protected against the effects of temporary immersion in water.
Do not reuse EN 980, Clause 5.2 Symbols for use in the labelling of medical devices. 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 5.4.2 Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied.
ISO 7000-1051 Graphical symbols for use on equipment.
Do not resterilize EN 980, Clause 5.22 Symbols for use in the labelling of medical devices. Do not resterilize Indicates a medical device that is not to be resterilized.
ISO 15223-1, Clause 5.2.6 Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied.
ISO 7000-2608 Graphical symbols for use on equipment.
Open here ISO 7000-3079 Graphical symbols for use on equipment. Open here To identify the location where the package can be opened and to indicate the method of opening it.
Contains natural rubber or latex EN 980, Clause 6.2 Symbols for use in the labelling of medical devices. Contains natural rubber or 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, Clause 5.4.5 Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied.
Non sterile EN 980, Clause 5.23 Symbols for use in the labelling of medical devices. Non sterile Indicates a medical device that has not been subjected to a sterilization process.
ISO 15223-1, Clause 5.2.7 Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied.
ISO 7000-2609 Graphical symbols for use on equipment.
Product subjected to a sterilization process EN 980, Clause 5.7 Symbols for use in the labelling of medical devices. Product subjected to a sterilization process Indicates a medical device that has been subjected to a sterilization process.
ISO 15223-1, Clause 5.2.1 Medical devices — Symbols to be used with medical device labels, labelling and information...
ISO 7000-2499 Graphical symbols for use on Equipment.
Sterilized by ethylene oxide treatment EN 980, Clause 5.8.2 Symbols for use in the labelling of medical devices. Sterilized by ethylene oxide treatment Indicates a medical device that has been sterilized using ethylene oxide.
ISO 15223-1, Clause 5.2.3 Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied.
ISO 7000-2501 Graphical symbols for use on equipment.
Sterilized using irradiation EN 980, Clause 5.8.3 Symbols for use in the labelling of medical devices. Sterilized using irradiation Indicates a medical device that has been sterilized using irradiation.
ISO 15223-1, Clause 5.2.4 Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied.
ISO 7000-2502 Graphical symbols for use on equipment.
Sterilized using steam or dry heat EN 980, Clause 5.8.4 Symbols for use in the labelling of medical devices. Sterilized using steam or dry heat Indicates a medical device that has been sterilized using steam or dry heat.
ISO 15223-1, Clause 5.2.5 Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied.
ISO 7000-2503 Graphical symbols for use on equipment.
Non-pyrogenic ISO 15223-1, Clause 5.6.3 Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied . Non-pyrogenic Indicates a medical device that is non-pyrogenic.
ISO 7000-2724 Graphical symbols for use on equipment.
Do not use if package is damaged 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 Indicates a medical device that should not be used if the package has been damaged or opened.
ISO 7000-2606 Graphical symbols for use on equipment.
Recycle: Electronic 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 THROW IN TRASH.
DEHP di(2-ethylexyl) phthalate EN 15986, Clause 4.2 Symbol for use in the labelling of medical devices. Requirements for labelling of medical devices containing phthalates. DEHP di(2-ethylexyl) phthalate Indicates presence of di(2-ethylhexyl Phthalate (DEHP).

SYMBOLS NOT FROM STANDARDS


SYMBOL REFERENCE TITLE SYMBOL TITLE EXPLANATORY TEXT
Prescription only 21 CFR 801.15(c)(1)(i)F Labeling-Medical devices; prominence of required label statements. Prescription only Requires prescription in the United States.
21 CFR 801.109 Labeling-Prescription devices.
CE marking 765/2008/EC 768/2008/EC MDD 93/42/EEC Articles 4,11,12,17, Annex II ) The requirements for accreditation and market surveillance relating to the marketing of products; Medical Device Directive. CE marking Signifies European technical conformity.
Federal Communication Commission Number (47 CFR Part 15) Radio Frequency Devices (US). Federal Communication Commission Number (FCC ID #) Complies with United States Radio communication requirements.
Industry Canada Radio Communications License (RSS-102) Radio Standards Specifications (CA). Industry Canada Radio Communications License (IC:#) Complies with Industry Canada Radio communication requirements.
Australian Radio Communications License (AS/NZS 4417.1:2012) Australian Radio Communications Requirements. Australian Radio Communications License Complies with Australian Radio communications requirements.
Japan Radio Communications License (MIC Article 38-33) Japan Radio Law. Japan Radio Communications License Complies with Japan Radio Law Notice 88.
Bluetooth wireless or enabled technology (Trademarks of Bluetooth Special Interest Group (SIG) N/A Bluetooth® wireless or enabled technology Bluetooth® wireless or enabled technology.
Configuration N/A N/A Configuration Configuration or unique version identifier.
Manufacturing Site N/A N/A Manufacturing Site Indicates the manufacturing site of the device. A manufacturing site is the facility where the product is produced, transformed, or assembled into a medical device.
Not made with natural rubber latex N/A N/A Not made with natural rubber latex Not made with natural rubber latex.
Non-pyrogenic N/A N/A Non-pyrogenic Indicates a medical device that is non-pyrogenic.
Replace every three days N/A N/A Replace every three days Indicates the user to replace on 3rd day of use (or as directed by physician).
AAA battery type N/A N/A AAA battery type Requires AAA battery type.