Symbols glossary
Complete reference of the ISO 15223-1 symbols found on medical device labels, plus the CE marking. The symbols actually used on U.Jet products are flagged.
Conformity
CE marking U.Jet
Conformity with Regulation (EU) 2017/745. The adjacent 4-digit number identifies the notified body.
Reg. (UE) 2017/745Manufacturer identification and information
Manufacturer U.Jet
Indicates the medical device manufacturer.
ISO 15223-1 · 5.1.1Authorized representative in the European Community/Union
The manufacturer's authorised representative in the EU.
ISO 15223-1 · 5.1.2Date of manufacture
Indicates the date the device was manufactured.
ISO 15223-1 · 5.1.3Use-by date U.Jet
Expiry date: do not use after this date.
ISO 15223-1 · 5.1.4Batch code U.Jet
Identifies the production batch for traceability.
ISO 15223-1 · 5.1.5Catalogue number U.Jet
The product code (REF) to quote when ordering.
ISO 15223-1 · 5.1.6Serial number
Identifies a specific single device.
ISO 15223-1 · 5.1.7Importer
Indicates the entity importing the device into the EU.
ISO 15223-1 · 5.1.8Distributor
Indicates the distributor of the medical device.
ISO 15223-1 · 5.1.9Model number
Identifies the device model or type.
ISO 15223-1 · 5.1.10Country of manufacture
Indicates the country where the device is made.
ISO 15223-1 · 5.1.11Sterilization and sterile packaging
Sterile
The device is sterile.
ISO 15223-1 · 5.2.1Sterilized using aseptic processing
Sterile, produced by aseptic processing.
ISO 15223-1 · 5.2.2Sterilized using ethylene oxide U.Jet
Sterile product, sterilized with ethylene oxide (EO).
ISO 15223-1 · 5.2.3Sterilized using irradiation
Sterile product, sterilized by irradiation.
ISO 15223-1 · 5.2.4Sterilized using steam or dry heat
Sterile product, sterilized with steam or dry heat.
ISO 15223-1 · 5.2.5Do not resterilize U.Jet
The device must not be sterilized again.
ISO 15223-1 · 5.2.6Non-sterile
The device is not sterile.
ISO 15223-1 · 5.2.7Do not use if the package is damaged U.Jet
Sterility is not guaranteed if the package is open or damaged.
ISO 15223-1 · 5.2.8Sterile fluid path
Indicates a sterile fluid path within the device.
ISO 15223-1 · 5.2.9Sterilized using vaporized hydrogen peroxide
Sterile product, sterilized with vaporized H₂O₂.
ISO 15223-1 · 5.2.10Single sterile barrier system U.Jet
Packaging with a single sterile barrier.
ISO 15223-1 · 5.2.11Double sterile barrier system
Packaging with a double sterile barrier.
ISO 15223-1 · 5.2.12Single sterile barrier with protective packaging inside
Single sterile barrier with protection inside.
ISO 15223-1 · 5.2.13Single sterile barrier with protective packaging outside
Single sterile barrier with protection outside.
ISO 15223-1 · 5.2.14Storage and handling
Fragile, handle with care
Handle carefully to avoid damaging the product.
ISO 15223-1 · 5.3.1Keep away from sunlight U.Jet
Protect the product from sunlight.
ISO 15223-1 · 5.3.2Protect from heat and radioactive sources
Keep away from heat and radioactive sources.
ISO 15223-1 · 5.3.3Keep dry U.Jet
Protect from moisture during storage.
ISO 15223-1 · 5.3.4Lower limit of temperature
Do not store below the indicated temperature.
ISO 15223-1 · 5.3.5Upper limit of temperature
Do not store above the indicated temperature.
ISO 15223-1 · 5.3.6Temperature limit U.Jet
Store within the indicated temperature limits.
ISO 15223-1 · 5.3.7Humidity limitation
Store within the indicated humidity limits.
ISO 15223-1 · 5.3.8Atmospheric pressure limitation
Store within the indicated pressure limits.
ISO 15223-1 · 5.3.9Warnings and safe use
Biological risks
Indicates a biological hazard.
ISO 15223-1 · 5.4.1Do not re-use U.Jet
Single-use device: use only once.
ISO 15223-1 · 5.4.2Consult instructions for use U.Jet
Read the instructions for use before use.
ISO 15223-1 · 5.4.3Caution U.Jet
Read the warnings and precautions in the instructions.
ISO 15223-1 · 5.4.4Contains natural rubber latex
The product contains natural rubber latex.
ISO 15223-1 · 5.4.5Contains human blood or plasma derivatives
The product contains human blood/plasma derivatives.
ISO 15223-1 · 5.4.6Contains a medicinal substance
The product contains a medicinal substance.
ISO 15223-1 · 5.4.7Contains material of animal origin
The product contains animal-origin biological material.
ISO 15223-1 · 5.4.8Contains material of human origin
The product contains human-origin biological material.
ISO 15223-1 · 5.4.9Contains hazardous substances
The product contains hazardous substances.
ISO 15223-1 · 5.4.10Contains nanomaterials
The product contains nanomaterials.
ISO 15223-1 · 5.4.11Single patient – multiple use
Reusable on a single patient only.
ISO 15223-1 · 5.4.12In vitro diagnostic (IVD) devices
In vitro diagnostic medical device
Device intended for in vitro diagnostic (IVD) use.
ISO 15223-1 · 5.5.1Control
Control material for IVD tests.
ISO 15223-1 · 5.5.2Negative control
Negative control material.
ISO 15223-1 · 5.5.3Positive control
Positive control material.
ISO 15223-1 · 5.5.4Contains sufficient for <n> tests
Indicates the number of tests that can be performed.
ISO 15223-1 · 5.5.5For IVD performance evaluation only
For performance evaluation use only.
ISO 15223-1 · 5.5.6Fluid path and sampling
Sampling site
Indicates the sample sampling site.
ISO 15223-1 · 5.6.1Fluid path
Indicates the fluid path within the device.
ISO 15223-1 · 5.6.2Non-pyrogenic
The device is non-pyrogenic.
ISO 15223-1 · 5.6.3Drops per millilitre
Indicates the number of drops per millilitre.
ISO 15223-1 · 5.6.4Liquid filter with pore size
Filter with the indicated pore size.
ISO 15223-1 · 5.6.5One-way valve
Allows flow in one direction only.
ISO 15223-1 · 5.6.6Patient information and other symbols
Patient number
Identifies the patient by number.
ISO 15223-1 · 5.7.1Patient name
Indicates the patient's name.
ISO 15223-1 · 5.7.2Patient identification
Identifies the patient.
ISO 15223-1 · 5.7.3Patient information website
Points to the website with patient information.
ISO 15223-1 · 5.7.4Health care centre or doctor
Indicates the health care centre or doctor.
ISO 15223-1 · 5.7.5Date
Indicates a date.
ISO 15223-1 · 5.7.6Medical device U.Jet
The product is a medical device.
ISO 15223-1 · 5.7.7Translation
Indicates a translation of the original information.
ISO 15223-1 · 5.7.8Repackaging
Indicates the product has been repackaged.
ISO 15223-1 · 5.7.9Unique device identifier (UDI)
Carries the device's unique identifier.
ISO 15223-1 · 5.7.10