Symbol Glossary

ISO 15223-1, Clause 5.1.1

Manufacturer

Indicates the medical device manufacturer.

ISO 15223-1, Clause 5.7.7

Medical Device

Indicates the item is a medical device.

ISO 15223-1, Clause 5.1.6

Catalogue or Model Number

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

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, Reference 5.1.3

Date of manufacture

Indicates the date when the medical device was manufactured.

ISO 15223-1, Clause 5.1.4

Do not use after expiry 

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

ISO 15223-1, Clause 5.4.3

Read the Instruction for Use (IFU)

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

ISO 15223-1, Clause 5.4.2

Single use only

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

EN 15986, Clause 4.2

Contains or presence of Phathalate

Contains phthalate

ISO 15223-1, Clause 5.3.4

Keep it Dry

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

ISO 15223-1, Clause 5.6.3

Non-pyrogenic

Indicates a medical device that is non-pyrogenic.

ISO 15223-1, Clause 5.3.2

Keep out of direct sunlight

Indicates a medical device that needs protection from light sources.

Latex free

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.

ISO 15223-1, Clause 5.2.6

Do not re-sterlize

Indicates a medical device that is not to be resterilized.

ISO 15223-1, Clause 5.3.7

Temperature

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

ISO 3826-2, Clause 4.3.1

Empty plastic container

On medical devices or blood process application: to indicate that the processing or final container is used for the purpose of whole blood or blood component storage.

Non-harmonized Symbol

Freezing Bag

Indicates that the product is intended for freezing at cryogenic temperatures. Values displayed to the right of the image indicate the validated freeze volume.

ISO 3826-2, Clause 4.4.7

Processing container

On medical devices or blood process application: to indicate that the processing of final container is used for the achievement of a process.

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

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

   
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