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GLOSSARY OF SYMBOLS


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 ISO 7010-M002, 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 Follow instructions for use
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.
Caution: Read all warnings and precautions in instructions for use EN 980, Clause 5.11 Symbols for use in the labelling of medical devices. 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.
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.
Rechargeable battery IEC 60417-5639 Graphical Symbols for Use on Equipment (derivative symbol and meaning) Rechargeable battery Recharge by date
ISO 7000-5639
IEC 60417-5546 Battery check
ISO 7000-5546
Graphical Symbols for Use on Equipment ISO 7000-5007 Graphical Symbols for Use on Equipment (derivative meaning) ON (power) Activate by date
ISO 7000-5008 OFF (power)
ISO 7000-5010 OFF (power)
IEC 60417-5007
IEC 60417-5008
IEC 60417-5010
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 "X".
Degree of Ingress Protection 22 Provided by Enclosure Protection against insertion of large objects and dripping water.
Degree of Ingress Protection 28 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 48 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 X8 Provided by Enclosure Protected against the effects of continuous immersion in water.
Degree of Ingress Protection X7 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.
Single sterile barrier system ISO 7000-3707 Graphical symbols for use on equipment Single sterile barrier system Single sterile barrier system
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.
Non-pyrogenic 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 Non-pyrogenic Indicates a medical device that is non-pyrogenic.
Not made with natural rubber latex 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.
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 dispose of this product in unsorted municipal waste stream.

DEHP di(2-ethylexyl) phthalate

BBP (Benzyl butyl phthalate)

DBP (Dibutyl 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

BBP (Benzyl butyl phthalate)

DBP (Dibutyl phthalate)
Contains phthalate
MD medical devices ISO/DIS 15223- 1:2020(E) DRAFT Reference no. 5.7.7 Medical Devices — Symbols to be used with medical device labels, labeling, and information to be supplied — Part 1: General requirements. Medical device Indicates the item is a medical device.


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 )
RED 2014/53/EU (Articles 19, 20, Annex II)
Conformité Européenne (European Conformity). This symbol means that the device fully complies with applicable European Union Acts. CE marking Signifies European technical conformity.
Federal Communication Commission Number (47 CFR Part 2 & 15) Code of Federal Regulations
Title 47: Telecommunication
Part 2:Frequency allocations and radio treaty matters; general rules and regulations
Part 15: Radio Frequency Devices (US).
Federal Communication Commission Identifier (FCC ID #) Complies with United States Regulations for Radio Frequency Devices.
Industry Canada Radio Communications License (RSS-GEN and RSP-100) Radio Standards Specifications (CA). Innovation, Science and Economic Development (ISED) Canada Identifier (IC:#) Complies with ISED Canada Radio Standards Specifications.
Australian Radio Communications License Radiocommunications (Compliance labelling- Devices) Notice and Radiocommunications Labelling (Electromagnetic Compatibility) Notice Australia/New Zealand (ANZ) Radiocommunications Requirements. Regulatory Compliance Mark (RCM) Complies with ANZ radiocommunications requirements.
Japan Radio Communications License Article 38 and Notice 88 Japan Radio Law and Ordinance Concerning Technical regulations Conformity Certification of Specified Radio Equipment. Giteki; Technical Conformity Mark Complies with Japan Radio Law.
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.
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).
Global Trade Identification Number N/A N/A Global Trade Identification Number Custom symbol denoting global trade item number.
Reimbursement number N/A N/A Reimbursement number Custom symbol

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