Symbol

Standard Reference

Symbol Title

Explanatory Text

labels-manufacturer

ISO 15223-1, Clause 5.1.1

Manufacturer

Indicates the medical device manufacturer.

ISO 15223-1, Clause 5.1.2

Authorized Representative in the European Community / European Union

Indicates the Authorized representative in the European Community / European Union.

ISO 15223-1, Clause 5.1.6

Catalogue or Model Number

Indicates the manufacturer’s catalogue number so that the medical device can be identified.

ISO 15223-1, Clause 5.1.5

Batch Code or Lot Number

Indicates the manufacturer’s batch code so that the batch or lot can be identified.

ISO 15223-1, Clause 5.1.4

Use-By Date

Indicates the date after which the medical device is not to be used.

ISO 15223-1, Clause 5.4.3

Consult Instructions for Use or Consult Electronic Instructions for Use

Indicates the need for the user to consult the instructions for use.

ISO 15223-1, Clause 5.4.4

Caution

Indicates that caution is necessary when operating the device or control close to where the symbol is placed, or that the current situation needs operator awareness or operator action in order to avoid undesirable consequences.

US FDA Guidance: Alternative to Certain Prescription Device Labeling Requirements

Prescription Only

Caution: Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner.

ISO 15223-1, Clause 5.3.4

Keep Dry

Indicates a medical device that needs to be protected from moisture.

ISO 15223-1, Clause 5.2.1

Sterile

Indicates a medical device that has been subjected to a sterilization process.

ISO 15223-1, Clause 5.2.3

Sterilized Using Ethylene Oxide

Indicates a medical device that has been sterilized using ethylene oxide.

33cb484d-862d-4f6a-bbbf-4d8d64e4e73d_200

ISO 15223-1, Clause 5.2.9

Sterile Fluid Path

Indicates the presence of a sterile fluid path within the medical device in cases when other parts of the medical device, including the exterior, might not be supplied sterile.

ISO 15223-1, Clause 5.2.4

Sterilized Using Irradiation

Indicates a medical device that has been sterilized using irradiation.

ISO 15223-1, Clause 5.2.2

Sterilized Using Aseptic Processing Techniques

Indicates a medical device that has been manufactured using accepted aseptic techniques.

ISO 15223-1, Clause 5.2.8

Do Not Use if Package is Damaged and Consult Instructions for Use

Indicates that a medical device that should not be used if the package has been damaged or opened and that the user should consult the instructions for use for additional information.

ISO 15223-1, Clause 5.3.2

Keep Away from Sunlight

Indicates a medical device that needs protection from light sources.

ISO 15223-1, Clause 5.4.2

Do Not Reuse

Indicates a medical device that is intended for one single use only.

ISO 15223-1, Clause 5.6.3

Non-Pyrogenic

Indicates a medical device that is non-pyrogenic.

ISO 15223-1, Clause 5.6.2

Fluid Path

Indicates the presence of a fluid path.

ISO 15223-1, Clause 5.2.6

Do Not Resterilize

Indicates a medical device that is not to be resterilized.

ISO7000

Quantity

Indicates the number of units in the associated packaging.

ISO 15223-1, Clause 5.3.7

Temperature Limit

Indicates the temperature limits to which the medical device can be safely exposed.