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Symbols Glossary Definition

Symbols Derived from Standards

SymbolStandard ReferenceStandard TitleSymbol TitleExplanatory Text
symbol-standards
ISO 15223-1, Reference 5.1.1Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements.ManufacturerIndicates the medical device manufacturer.
symbol-standards
ISO 15223-1, Reference 5.1.2Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements.Authorized representative in the European CommunityIndicates the Authorized representative in the European Community.
symbol-standards
ISO 15223-1, Reference 5.1.3Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements.Date of manufactureIndicates the date when the medical device was manufactured.
symbol-standards
ISO 15223-1, Reference 5.1.4Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements.Use-by dateIndicates the date after which the medical device is not to be used.
Batch Code
ISO 15223-1, Reference 5.1.5Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements.Batch codeIndicates the manufacturer's batch code so that the batch or lot can be identified.
Catalog Number
ISO 15223-1, Reference 5.1.6Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements.Catalogue numberIndicates the manufacturer's catalogue number so that the medical device can be identified.
Serial Number
ISO 15223-1, Reference 5.1.7Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements.Serial numberIndicates the manufacturer's serial number so that a specific medical device can be identified.
Sterile
ISO 15223-1, Reference 5.2.1Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements.SterileIndicates a medical device that has been subjected to a sterilization process.
Sterilized using ethylene oxide
ISO 15223-1, Reference 5.2.3Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements.Sterilized using ethylene oxideIndicates a medical device that has been sterilized using ethylene oxide.
Sterilized using irradiation
ISO 15223-1, Reference 5.2.4Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements.Sterilized using irradiationIndicates a medical device that has been sterilized using irradiation.
Not to be sterilized
ISO 15223-1, Reference 5.2.6Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements.Do not resterilizeIndicates a medical device that is not to be resterilized.
Non-sterile
ISO 15223-1, Reference 5.2.7Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements.Non-sterileIndicates a medical device that has not been subjected to a sterilization process.
Do not use if package is damaged
ISO 15223-1, Reference 5.2.8Medical 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 damagedIndicates a medical device that should not be used if the package has been damaged or opened.
Keep away from sunlight
ISO 15223-1, Reference 5.3.2Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements.Keep away from sunlightIndicates a medical device that needs protection from light sources.
Lower limit of temperature
ISO 15223-1, Reference 5.3.5Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements.Lower limit of temperatureIndicates the lower limit of temperature to which the medical device can be safely exposed.
Upper limit of temperature
ISO 15223-1, Reference 5.3.6Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements.Upper limit of temperatureIndicates the upper limit of temperature to which the medical device can be safely exposed.
Temperature limit
ISO 15223-1, Reference 5.3.7Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements.Temperature limitIndicates the temperature limits to which the medical device can be safely exposed.
Do not use
ISO 15223-1, Reference 5.4.2Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements.Do not reuseIndicates a medical device that is intended for one use, or for use on a single patient during a single procedure.
Consult instructions for use
ISO 15223-1, Reference 5.4.3Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements.Consult instructions for useIndicates the need for the user to consult the instructions for use.
Consult electronic instructions for use
ISO 15223-1, Reference 5.4.3Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements.Consult electronic instructions for useIndicates the need for the user to consult the electronic instructions for use (eIFU) at the specified website location.
Caution
ISO 15223-1, Reference 5.4.4Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements.CautionIndicates 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.
Contains or presence of natural rubber
ISO 15223-1, Reference 5.4.5Medical 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 latexIndicates 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.
Single patient - multiple use
ISO 15223-1, Reference 5.4.12Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements.Single patient - multiple useIndicates a medical device that may be used multiple times (multiple procedures) on a single patient.
Patient number
ISO 15223-1, Reference 5.7.1Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements.Patient numberIndicates a unique number associated with an individual patient.
Warning: Flammable material
ISO 7010, Reference W021Graphical symbols — Safety colours and safety signs — Registered safety signsWarning; Flammable materialTo warn of flammable material.
Warning: Corrosive substance
ISO 7010, Reference W023Graphical symbols — Safety colours and safety signs — Registered safety signsWarning; Corrosive substanceTo warn of corrosive substance.

Symbols Not Derived from Standards

SymbolStandard ReferenceStandard TitleSymbol TitleExplanatory Text

Rx Only

21 CFR 801.109Labeling; Prescription devicesPrescription use onlyCaution: Federal law (USA) restricts this device to sale by or on the order of a licensed healthcare practitioner.
European conformity
MDD 93/42/EEC Annex II; MDR 2017/745 Annex VThe requirements for accreditation and market surveillance relating to the marketing of products; Medical Device Directive and Medical Device Regulation.European conformityEuropean conformity (CE) mark for Class I medical devices.
European conformity
MDD 93/42/EEC Annex II; MDR 2017/745 Annex VThe requirements for accreditation and market surveillance relating to the marketing of products; Medical Device Directive and Medical Device Regulation.European conformityEuropean 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
European conformity
MDD 93/42/EEC Annex II; MDR 2017/745 Annex VThe requirements for accreditation and market surveillance relating to the marketing of products; Medical Device Directive and Medical Device Regulation.European conformityEuropean conformity (CE) mark with Notified Body identification number for Class Im, Ir, Is, IIa, IIb, III medical devices Notified Body No. 2797: BSI, Netherlands
Medical device
MDR 2017/745 Annex 1 23.2(q)The requirements for indicating that a device is a medical device; Medical Device Regulation.Medical deviceIndicates that the device is a medical device.
Telephone receiver or handset
N/AN/ATelephone receiver or handsetIndicates the telephone contact number.
Virtual Assistant X