Symbols Used in Medical Device Packaging and Labeling

 Symbol for "Serial Number." This symbol shall be followed by, or above, the manufacturer's serial number.

Symbol for "Batch Code." This symbol shall be adjacent to the manufacturer's batch code. The batch code may also be referred to as the lot number or batch number.

 Symbol for "Manufacturer." This symbol shall be adjacent to the name and address of the manufacturer.

Symbol indicating the "date of manufacture." The symbol shall be adjacent to the date that the product was manufactured, expressed as four digits for the year and two digits for the month and where appropriate, two digits for the day.

Symbol that may be used in place of the statement "CAUTION: U.S. Federal law restricts this device to sale by or on the order of a physician."

Symbol for "Use By." This symbol shall be adjacent to the expiration date, as given in EN 28601, expressed as four digits for the year and two digits for the month and where appropriate, two digits for the day. This symbol is intended to indicate that the device should not be used after the end of the month shown, or the day, if applicable.

Symbol for sterile medical devices processed using aseptic techniques.

Symbol for method of sterilization using ethylene oxide.

Symbol for method of sterilization using irradiation.

Symbol for the method of sterilization using vaporized hydrogen peroxide.

Symbol for method of sterilization using steam or dry heat.

Symbol indicating that the device has not been sterilized.

Symbol for "do not re-use," "single use," or "use only once."

Symbol for "Caution, consult accompanying documents" or "Attention, see instructions for use."

Symbol for "Consult instructions for use" or "Consult operating instructions."

Symbol for "Authorized Representative in the European Community." This symbol shall be adjacent to the name and address of the authorized representative in the European Community. The address is not required on an immediate container unless the immediate container is the outer container.

Symbol for "temperature limitation." The upper and lower temperature limits will be indicated on either side of the symbol.

This symbol is a mandatory marking for devices entering the European market to indicate conformity with the essential health and safety requirements set out in European Directives. The symbol may be accompanied by a four-digit identification number of the notified body. The vertical dimensions may not be less than 5 mm high.

Symbol for "non-ionizing radiation." All equipment and systems that include RF transmitters or that intentionally apply RF electromagnetic energy for diagnosis or treatment must be labeled with this symbol.

Symbol for "Shock protection type (B, BF, CF)."

Symbol indicating "Not for general waste." For European Union (EU) States, this symbol should be used to mark devices that are reusable and not contaminated at the end of the device life.

Symbol indicating to "Keep away from sunlight."

Symbol used to indicate that the product should be kept dry.

Symbol indicating that the device is "fragile" and should be handled with care.

Symbol indicating that the product packaging is able to be recycled.

Note:

Symbols were derived from "ISO 15223 Medical Devices - Symbols to be Used with Medical Device Labels, Labelling and Information to be Supplied," "Council Directive 93/42/EEC of 14 June 1993 Concerning Medical Devices," "Council Directive 90/385/EEC of 20 June 1990 on Active Implantable Medical Devices," and " Council Directive 98/79/EC of 27 October 1998 on In Vitro Diagnostic Medical Devices."

CE marking

CE marking is a legal requirement for medical devices intended for sale in Europe. The CE marking certifies that a product has met EU consumer safety, health or environmental requirements.

There are three European CE marking directives that specifically apply to medical devices manufacturers:

1.)The Medical Devices Directive (MDD) applies to all general medical devices not covered by the Active Implantable Medical Devices Directive or the In Vitro Diagnostics Directive.
2.)The Active Implantable Medical Devices Directive (AIMDD) applies to all active devices and related accessories intended to be permanently implanted in humans.
3.)The In Vitro Diagnostics Directive (IVDD) applies to all devices and kits used away from the patient to make a diagnosis of patient medical conditions.

 The marking is mandatory for products sold not only within the 27 countries of the European Union (Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom) but more generally within all countries of the European Economic Area (EEA) which also includes the 4 countries of the European Free Trade Area (EFTA: Iceland, Liechtenstein, Norway, including Switzerland although it is not a member of the EEA), as well as within Turkey (as a result of the non-agricultural European Union-Turkey Customs Union).

IEC 60878 SYMBOLS

SYMBOLS FOR ELECTRICAL EQUIPMENT IN MEDICAL PRACTICE

ELECTRICAL SYMBOLS

SYMBOLS OF PIPING INSTRUMENTATION