Symbol Glossary

ISO 15223-1: 5.1. Manufacture

SymbolTitleReferenceDescription
Manufacturer5.1.1.Indicates the medical device manufacturer.
EU Rep IconAuthorized representative in the European Union5.1.2.Indicates the authorized representative in the European Union.
Date of manufacture5.1.3.Indicates the date when the medical device was manufactured.
Use-by date5.1.4.Indicates the date after which the medical device is not to be used.

NOTE: Synonyms for “use-by date” are “use by”, “expiry date” and “expiration date”.
Lot number5.1.5.Indicates the manufacturer’s batch code so that the batch or lot can be identified.
Catalog number5.1.6.Indicates the manufacturer’s catalogue number so that the medical device can be identified.

NOTE: Synonyms for “catalog number” are “commercial product name”, “commercial product code”, stock keeping unit, “reference number” and “reorder number”.
Importer5.1.8.Indicates the entity importing the medical device into the locale.
Serial number5.1.7.Indicates the manufacturer’s serial number so that a specific medical device can be identified.

ISO 15223-1: 5.2. Sterility

SymbolTitleReferenceDescription
Sterilized using ethylene oxide5.2.3.Indicates a medical device that has been sterilized using ethylene oxide.
Do Not Resterilize5.2.6.Indicates a medical device that is not to be resterilized.
Non-Sterile5.2.7.Indicates a medical device that has not been subjected to a sterilization process.
Do not use if package is damaged and consult instructions for use5.2.8.Indicates a medical device that should not be used if the package has been damaged or opened.

NOTE 1: This symbol can also mean “Do not use if the product sterile barrier system or its packaging is compromised”.
Single sterile barrier system5.2.11.Indicates a single sterile barrier system.

ISO 15223-1: 5.3. Storage

SymbolTitleReferenceDescription
Fragile, handle with care5.3.1.Indicates a medical device that can be broken or damaged if not handled carefully.
Keep away from sunlight5.3.2.Indicates a medical device that needs protection from light sources.

NOTE: This symbol can also mean “Keep away from heat”.
Keep dry5.3.4.Indicates a medical device that needs to be protected from moisture.
Temperature limit5.3.7.Indicates the temperature limits to which the medical device can be safely exposed.
Humidity limitation5.3.8.Indicates the range of humidity to which the medical device can be safely exposed.

ISO 15223-1: 5.4. Safe use

SymbolTitleReferenceDescription
Do not re-use5.4.2.Indicates a medical device that is intended for one single use only.
Consult instructions for use5.4.3.

A.16 NOTE		A.16 Example of use of symbol 5.4.3, “Consult instructions for use” for an electronic instruction for use (eIFU)

NOTE: The eIFU indicator can be a manufacturer’s website URL or some other appropriate indication that the instructions for use are available in an electronic format.
Caution5.4.4.To indicate that caution is necessary when operating the device or control close to where the symbol is placed, or to indicate that the current situation needs operator awareness or operator action in order to avoid undesirable consequences.
Not made with bis (2-ethylhexyl) phthalate (DEHP)BS EN 15986:2011
EN 15986:2011(E)
Annex B
Contains or presence of phthalate": bis (2-ethylhexyl) phthalate (DEHP)BS EN 15986:2011
EN 15986:2011(E) Clause 4.2
Annex A
Not made with natural rubber latex
Single patient-multiple use5.4.12.Indicates a medical device that may be used multiple times (multiple procedures) on a single patient.

ISO 15223-1: 5.6. Transfusion/infusion

SymbolTitleReferenceDescription
Non-pyrogenic5.6.3.Indicates a medical device that is non-pyrogenic.

ISO 15223-1: 5.7. Others

SymbolTitleReferenceDescription
Medical device5.7.7.Indicates the item is a medical device (under EU Legislation).
Unique Device Identifier5.7.10.Indicates a carrier that contains Unique Device Identifier information.

IEC 60601-1: General Symbols

SymbolTitleReferenceDescription
Type BF applied partTable D.1, Symbol 20To identify a type BF applied part complying with IEC 60601-1.
Follow instructions for useTable D.2, Symbol 10Symbol must appear in color. Limited to Medical Electrical Equipment covered by EN 60601-1.

IEC 60601-1: Degrees of Protection

SymbolTitleReferenceDescription
Finger-Sized Object & Tilted Drip Water ProtectionTable D.3, Symbol 2Indicates that product enclosure is protected against solid foreign objects of 12,5 mm and greater; and has protection against vertically falling water drops when ENCLOSURE tilted up to 15°.

ASTM F 2503: Magnetic Resonance

SymbolTitleReferenceDescription
MR UnsafeASTM F2503-20: 7.3.3An item which poses unacceptable risks to the patient, medical staff or other persons within the MR environment. (ASTM F2503-20:3.1.14)

Other Symbols

SymbolTitleReferenceDescription
Prescription Only21 CFR 801.109 (FDA)Caution: Federal law restricts this device to sale by or on the order of a physician
CE MarkConformity marking indicating that a product meets European Union (EU) safety, health, and environmental protection requirements.
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