Medical device label symbols
Symbols on medical device labels and packaging (ISO 15223-1): manufacturer and dates, LOT, REF and serial number, sterilisation method, single use, storage limits, IVD and control symbols, and importer, distributor and representative marks.
Atmospheric pressure limitationMedical device label symbolsAtmospheric pressure limitationGives the lower and upper limits of atmospheric pressure the medical device can safely be exposed to during transport and storage. The limits are printed next to the two strokes.On ISO 15223-1
Authorised representative in the EU (EC REP)Medical device label symbolsAuthorised representative in the EU (EC REP)The name and address next to this mark are those of the authorised representative in the European Community / European Union, who acts for a manufacturer based outside the EU. The same frame with another code, such as CH REP, names a representative for another jurisdiction.On ISO 15223-1
Authorised representative in the EU (EU REP)Medical device label symbolsAuthorised representative in the EU (EU REP)The name and address next to this mark are those of the manufacturer's authorised representative in the European Union. This EU REP form is given in the 2025 amendment of the standard; older labels show EC REP instead.On ISO 15223-1
Batch code (LOT)Medical device label symbolsBatch code (LOT)The code printed next to LOT is the manufacturer's batch (lot) number, which identifies the production batch the device or kit belongs to. It lets that batch be identified, for example in records or when contacting the manufacturer.On ISO 15223-1
Biological risks (biohazard)Medical device label symbolsBiological risks (biohazard)Warns that the device may pose a biological hazard, for example because it contains material that could carry something infectious such as a virus. It is used on devices, reagents and analysers that may carry such material.On ISO 15223-1
Catalogue number (REF)Medical device label symbolsCatalogue number (REF)The number next to REF is the manufacturer's catalogue (article or reference) number, which identifies exactly which product this is. The same number may also be called the commercial product code.On ISO 15223-1
Consult instructions for use (book with i)2 meaningsConsult instructions for use (book with i)Tells the user to consult the instructions for use before using the device. On medical electrical equipment the same book symbol is also used to mean follow the operating instructions.Differs by brand.On ISO 15223-1
Contains hazardous substancesMedical device label symbolsContains hazardous substancesThe device contains substances that may be carcinogenic, mutagenic or toxic to reproduction (CMR), or that have endocrine-disrupting properties. Further details are given in the information supplied with the device.On ISO 15223-1
Contains natural rubber latexMedical device label symbolsContains natural rubber latexNatural rubber latex or dry natural rubber is used as a material in the device or in its packaging. This matters for people with a latex allergy.On ISO 15223-1
Contains sufficient for <n> testsMedical device label symbolsContains sufficient for <n> testsTells you how many IVD tests the kit or reagent is enough for in total. The actual number replaces or follows the letter n.On ISO 15223-1
Control (CONTROL)Medical device label symbolsControl (CONTROL)Marks a control material, used to check that another device, such as a test or analyser, performs as expected. Variants add a second box: minus for a negative control, plus for a positive control, or a number such as 1, 2 or 3 for different control levels.On ISO 15223-1
Date of manufacture (outline factory)Medical device label symbolsDate of manufacture (outline factory)The date printed next to this outlined factory is the date on which the medical device was manufactured. It is different from the filled factory, which identifies the manufacturer itself.On ISO 15223-1
DistributorMedical device label symbolsDistributorThe name and address next to this symbol are those of the company that distributes the medical device in the country or region where it is sold. It is separate from the manufacturer and the importer.On ISO 15223-1
Do not re-use (single use)Medical device label symbolsDo not re-use (single use)The device is meant for one use only, or for one patient during a single procedure, and must not be used again. The same symbol is read as "single use" or "use only once".On ISO 15223-1
Do not resterilizeMedical device label symbolsDo not resterilizeThe device is not to be resterilised. Do not put it through any sterilisation process again.On ISO 15223-1
Do not use if package is damagedMedical device label symbolsDo not use if package is damagedDo not use the device if its package has been damaged or opened, for example if the sterile barrier is compromised. Check the instructions for use for further information.On ISO 15223-1
Double sterile barrier systemMedical device label symbolsDouble sterile barrier systemThe device is packed in two sterile barrier systems, one inside the other, each keeping it sterile until opened. A single oval means only one such layer.On ISO 15223-1
Humidity limitationMedical device label symbolsHumidity limitationGives the range of humidity the medical device can safely be exposed to. The lower and upper limits, usually in percent relative humidity, are printed next to the two strokes.On ISO 15223-1
ImporterMedical device label symbolsImporterThe name and address next to this symbol are those of the company that imports the medical device into the country or region where it is sold. It is separate from the manufacturer and the distributor.On ISO 15223-1
In vitro diagnostic medical device (IVD)Medical device label symbolsIn vitro diagnostic medical device (IVD)Identifies the product as an IVD, a medical device intended for in vitro diagnostic testing. The mark appears on diagnostic reagents, kits, analysers and their accessories.On ISO 15223-1
Lower limit of temperatureMedical device label symbolsLower limit of temperatureThe temperature printed next to the bottom stroke is the lowest temperature the medical device can safely be exposed to. Keep it above this value in storage and transport.On ISO 15223-1
Manufacturer (filled factory)Medical device label symbolsManufacturer (filled factory)Marks the name and address of the company legally responsible as the manufacturer of the medical device; the details are printed next to the symbol. Some labels add a date beside the same filled factory to show the manufacturer and the date of manufacture together.On ISO 15223-1
Medical device (MD)Medical device label symbolsMedical device (MD)Shows that the item is a medical device. It is used in particular on products for the EU market, where medical devices are regulated as such under EU legislation.On ISO 15223-1
Non-sterileMedical device label symbolsNon-sterileThe device has not been through a sterilisation process and is supplied non-sterile. Do not treat it as sterile.On ISO 15223-1
Patient numberMedical device label symbolsPatient numberThe number written next to this symbol identifies one particular patient. It refers to the patient, not to the device or its batch.On ISO 15223-1
Serial number (SN)Medical device label symbolsSerial number (SN)The number next to SN is the manufacturer's serial number, which identifies this one individual device rather than a whole batch. It lets that specific unit be identified.On ISO 15223-1
Single patient, multiple useMedical device label symbolsSingle patient, multiple useThe device may be used several times, for multiple procedures, but only on the same single patient. It must not be used on another patient.On ISO 15223-1
Single sterile barrier systemMedical device label symbolsSingle sterile barrier systemThe device is packed in a single sterile barrier system, one layer of packaging that keeps it sterile until opened. A double ring means two such layers.On ISO 15223-1
SterileMedical device label symbolsSterileThe medical device has gone through a sterilisation process. Versions with an extra box after the word name the method used, such as EO, R or a thermometer for steam or dry heat.On ISO 15223-1
Sterilized using ethylene oxide (STERILE EO)Medical device label symbolsSterilized using ethylene oxide (STERILE EO)The device was sterilised using ethylene oxide (EO) gas. Like the other STERILE marks it means the contents are sterile as supplied.On ISO 15223-1
Sterilized using irradiation (STERILE R)Medical device label symbolsSterilized using irradiation (STERILE R)The device was sterilised using irradiation, shown by the R in the second box. Like the other STERILE marks it means the contents are sterile as supplied.On ISO 15223-1
Sterilized using steam or dry heatMedical device label symbolsSterilized using steam or dry heatThe device was sterilised using steam or dry heat, shown by the thermometer in the second box. Like the other STERILE marks it means the contents are sterile as supplied.On ISO 15223-1
Unique device identifier (UDI)Medical device label symbolsUnique device identifier (UDI)Marks the carrier that contains the device's unique device identifier (UDI) information, such as the code printed next to it. Read or scan that code to identify the device.On ISO 15223-1
Upper limit of temperatureMedical device label symbolsUpper limit of temperatureThe temperature printed next to the top stroke is the highest temperature the medical device can safely be exposed to. Keep it below this value in storage and transport.On ISO 15223-1