Symbol Glossary Definitions

 

SYMBOL STANDARD REFERENCE SYMBOL TITLE EXPLANATORY TEXT
labels-manufacturer.png ISO 15223-1, Clause 5.1.1 Manufacturer Indicates the medical device manufacturer.
labels-auth-euro-rep.png ISO 15223-1, Clause 5.1.2 Authorized European representative Indicates the Authorized representative in the European Community.
labels-catalogue.png 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.
LOT.jpg ISO 15223-1,
Clause 5.1.5
Batch code or lot number Indicated the manufacturer's batch code so that the batch or lot can be identified.
labels-use-by.png ISO 15223-1, Clause 5.1.4 Use by Indicates the date after which the medical device is not to be used.
labels-consult-inst.png ISO 15223-1, Clause 5.4.3 Consult instructions for use Indicates the need for the user to consult the instructions for use.
labels-attention.png ISO 15223-1, Clause 5.4.4 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.
labels-storage-temp-level.png ISO 15223-1, Clause 5.3.7 Storage temperature range Indicates the temperature limits to which the medical device can be safely exposed.
labels-keep-dry.png ISO 15223-1, Clause 5.3.4 Keep dry Indicates a medical device that needs to be protected from moisture.
labels-donot-reuse.png ISO 15223-1, Clause 5.4.2 Do not reuse Indicates a medical device that is intended for one use, or for use on a single patient during a single procedure.
labels-donot-resterilize.png ISO 15223-1, Clause 5.2.6 Do not resterilize Indicates a medical device that is not to be resterilized.
labels-sterile.png ISO 15223-1, Clause 5.2.1 Product subjected to a sterilization process Indicates a medical device that has been subjected to a sterilization process.
iso_grs_7000_3084_cropped.jpg ISO 15223-1, Clause 5.2.9 Sterile Fluid Path Indicates the presence of a sterile fluid path within the medical device.  The method of sterilization is indicated in the empty box.  E=Ethylene Oxide, R=Gamma Radiation, A=Aspeptic Fill
labels-sterile-eo.png ISO 15223-1, Clause 5.2.3 Sterilized by ethylene oxide treatment Indicates a medical device that has been sterilized using ethylene oxide.
labels-sterile-r.png ISO 15223-1, Clause 5.2.4 Sterilized using irradiation Indicates a medical device that has been sterilized using irradiation.
Sterile-A.gif

 

ISO 15223-1, Clause 5.2.2

 

Sterilized using aseptic fill Indicates a medical device that has been sterilized using aspectic fill.
labels-donot-use-damaged.png ISO 15223-1, Clause 5.2.8 Do not use if package is damaged Indicates a medical device that should not be used if the package has been damaged or opened.
icn_do_not_expose_to_sunlight.jpg ISO 15223-1, Clause 5.3.2 Keep away from sunlight Indicates a medical device that needs protection from light sources.
pyrogen.png ISO 15223-1, Clause 5.6.3 Non-pyrogenic Indicates a medical device that is non-pyrogenic.
  icn_quantity.jpg ISO7000 Quantity Indicates the number of units in the associated packaging.

SYMBOLS NOT FROM STANDARDS

 

SYMBOL REFERENCE SYMBOL TITLE EXPLANATORY TEXT
Rx_Only.jpg

US FDA Guidance:

Alternative to Certain PrescriptionDevice Labeling Requirements. 

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