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Commonly Used Symbols

Glossary of symbols commonly used on DeRoyal Medical Device Packaging and Labeling

symbol explanatory text standard title standard reference
Indicates the manufacturer's catalogue number so that the medical device can be identified. EN 980, Clause 5.10 Symbols for use in the labelling of medical devices.
ISO 15223-1, Clause 5.1.6 Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied.
Catalogue or model number ISO 7000- 2493 Graphical symbols for use on equipment.
Indicates the manufacturer's batch code so that the batch or lot can be identified. EN 980, Clause 5.4 Symbols for use in the labelling of medical devices.
ISO 15223-1, Clause 5.1.5 Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied.
Batch code ISO 7000-2492 Graphical symbols for use on equipment.
Indicates the manufacturer's serial number so that a specific medical device can be identified. EN 980, Clause 5.5 Symbols for use in the labelling of medical devices.
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 ISO 7000-2498 Graphical symbols for use on equipment.
Indicates a medical device that needs to be protected from moisture. EN 980, Clause 5.21 Symbols for use in the labelling of medical devices.
ISO 15223-1, Clause 5.3.4 Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied.
Keep dry ISO 7000-0626 Graphical symbols for use on equipment.
Indicates a medical device that needs protection from light sources. EN 980, Clause 5.20 Symbols for use in the labelling of medical devices.
ISO 15223-1, Clause 5.3.2 Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied.
Keep away from sunlight ISO 7000-0624 Graphical symbols for use on equipment.
Indicates the medical device manufacturer. EN 980, Clause 5.12 Symbols for use in the labelling of medical devices.
ISO 15223-1, Clause 5.1.1 Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied.
Manufacturer ISO 7000-3082 Graphical symbols for use on equipment.
Indicates the date when the medical device was manufactured. EN 980, Clause 5.6 Symbols for use in the labelling of medical devices.
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 ISO 7000-2497 Graphical symbols for use on equipment.
Requires prescription in the United States. 21 CFR 801.15(c)(1)(i)F Labeling-Medical devices; prominence of required label statements.
21 CFR 801.109 Labeling-Prescription devices.
Prescription only
Indicates a medical device that should not be used if the package has been damaged or opened. ISO 15223-1, Clause 5.2.8 Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied.
ISO 7000-2606 Graphical symbols for use on equipment.
Do not use if package is damaged
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. EN 980, Clause 6.2 Symbols for use in the labelling of medical devices.
ISO 15223-1, Clause 5.4.5 Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied.
Contains natural rubber or latex
Indicates the date after which the medical device is not to be used. EN 980, Clause 5.3 Symbols for use in the labelling of medical devices.
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 ISO 7000-2607 Graphical symbols for use on equipment.
Indicates the need for the user to consult the instructions for use. EN 980, Clause 5.18 Symbols for use in the labelling of medical devices.
ISO 15223-1, Clause 5.4.3 Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied.
Consult instructions for use 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.
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. EN 980, Clause 5.11 Symbols for use in the labelling of medical devices.
ISO 15223-1, Clause 5.4.4 Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied.
Caution IEC 60601-1, Table D.1, Symbol 10 Medical electrical equipment — Part 1: General requirements for basic safety and essential performance.
Indicates a medical device that is intended for one use, or for use on a single patient during a single procedure. EN 980, Clause 5.2 Symbols for use in the labelling of medical devices.
ISO 15223-1, Clause 5.4.2 Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied.
Do not reuse ISO 7000-1051 Graphical symbols for use on equipment.
Refer to instruction manual/booklet. 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
Indicates the temperature limits to which the medical device can be safely exposed. EN 980, Clause 5.17.3 Symbols for use in the labelling of medical devices.
ISO 15223-1, Clause 5.3.7 Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied.
Storage temperature range ISO 7000-0632 Graphical symbols for use on equipment.
Indicates the lower limit of temperature to which the medical device can be safely exposed. ISO 15223-1, Clause 5.3.5 Symbols for use in the labelling of medical devices.
EN 980 35.17.1 Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied.
Lower limit of storage temperature ISO 7000-0534 Graphical symbols for use on equipment.
Indicates the upper limit of temperature to which the medical device can be safely exposed. ISO 15223-1, Clause 5.3.6 Symbols for use in the labelling of medical devices.
EN 980 5.17.2 Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied.
Upper limit of storage temperature ISO 7000-0533 Graphical symbols for use on equipment.
Signifies European technical conformity. 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
Indicates the authorized representative in the European Community. EN 980, Clause 5.13 Symbols for use in the labelling of medical devices.
ISO 15223-1, Clause 5.1.2 Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied.
Authorized European representative
Indicates a medical device that is not to be resterilized. EN 980, Clause 5.22 Symbols for use in the labelling of medical devices.
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 ISO 7000-2608 Graphical symbols for use on equipment.
Indicates a medical device that has not been subjected to a sterilization process. EN 980, Clause 5.23 Symbols for use in the labelling of medical devices.
ISO 15223-1, Clause 5.2.7 Medical devices — Symbols to be used with medical device labels, labelling and information.
Non sterile ISO 7000-2609 Graphical symbols for use on equipment.
Indicates a medical device that has been subjected to a sterilization process. EN 980, Clause 5.7 Symbols for use in the labelling of medical devices.
ISO 15223-1, Clause 5.2.1 Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied.
Product subjected to a sterilization process ISO 7000-2499 Graphical symbols for use on equipment.
Indicates a medical device that has been sterilized using irradiation. EN 980, Clause 5.8.3 Symbols for use in the labelling of medical devices.
ISO 15223-1, Clause 5.2.4 Medical devices—Symbols to be used with medical device labels, labelling and information to be supplied.
Sterilized using irradiation ISO 7000-2502 Graphical symbols for use on equipment.
Indicates a medical device that has been sterilized using aseptic techniques. ISO 15223-1, Clause 5.2.2 Symbols for use in the labelling of medical devices.
Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied.
Sterilized using aseptic techniques Graphical symbols for use on equipment.
Indicates a medical device that has been sterilized using ethylene oxide. EN 980, Clause 5.8.2 Symbols for use in the labelling of medical devices.
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 ISO 7000-2501 Graphical symbols for use on equipment.
Indicates a medical device that has been sterilized using steam or dry heat. EN 980, Clause 5.8.4 Symbols for use in the labelling of medical devices.
ISO 15223-1, Clause 5.2.5 Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied.
Biological Risk ISO 7000-2503 Graphical symbols for use on equipment.
Indicates there are potential biological risks associated with the medical device. EN 980 5.19 Symbols for use in the labelling of medical devices.
ISO 15223 5.4.1 Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied.
Sterilized using steam or dry heat ISO 7000-0659 Graphical symbols for use on equipment.
Double insulated appliance IEC 60417-5172 Graphical symbols for use on equipment.
Double insulated appliance
Type BF applied part IEC 60417-5333 Graphical symbols for use on equipment.
Type BF applied part
Classifies and rates the degree of protection provided by casing/enclosure of electrical device.
• Protection against solid objects > 12.5 mm;
• Protection against water sprayed up to 15 from vertical
IEC 60529*

*(does not have a reference number per 60601-1 [2005] p.645)
Graphical symbols for use on equipment.
IP code,
International Protection Marking