Symbols - Henry Schein Orthodontics
19286
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Symbols

According to the EU Medical Devices Regulation, users / patients are obliged to report serious events with a
medical device to the manufacturer and to the competent authority of the country in which they occurred.

Symbol Symbol Title Symbol Description Standard Reference Standard Title
Manufacturer Indicates the medical device manufacturer. 5.1.1 ISO 15223-1:2021 Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements
Date of manufacture Indicates the date when the medical device was manufactured. 5.1.3 ISO 15223-1:2021 Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements
Authorized representative in the European Community
/ European Union
Indicates the authorized representative in the European Community
/ European Union.
5.1.2 ISO 15223-1:2021 Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements
Use-by date Indicates the date after which the medical device is not to be used. 5.1.4 ISO 15223-1:2021 Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements
Batch code Indicates the manufacturer’s batch code so that the batch or lot can be identified. 5.1.5 ISO 15223-1:2021 Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements
Catalogue number Indicates the manufacturer’s catalogue number so that the medical device can be identified. 5.1.6 ISO 15223-1:2021 Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements
Serial number Indicates the manufacturer’s serial number so that a specific medical device can be identified. 5.1.7 ISO 15223-1:2021 Medical devices – Symbols to be used with information to be supplied by the manufacturer -Part 1: General requirements
Sterile Indicates a medical device that has been subjected to a sterilization process. 5.2.1 ISO 15223-1:2021 Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements
Sterilized using aspectic processing techniques Indicates a medical device that has been manufactured using accepted aseptic techniques. 5.2.2 ISO 15223-1:2021 Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements
Sterilized using ethylene oxide Indicates a medical device that has been sterilized using ethylene oxide. 5.2.3 ISO 15223-1:2021 Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements
Sterilized using irradiation Indicates a medical device that has been sterilized using irradiation. 5.2.4 ISO 15223-1:2021 Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements
Sterilized using steam or dry heat Indicates a medical device that has been sterilized using steam or dry heat. 5.2.5 ISO 15223-1:2021 Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements
Do not resterilize Indicates a medical device that is not to be resterilized. 5.2.6 ISO 15223-1:2021 Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements
Non-sterile Indicates a medical device that has not been subjected to a sterilization process. 5.2.7 ISO 15223-1:2021 Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements
Do not use if package is damaged and consult instructions for use Indicates a medical device that should not be used if the package has been damaged or opened. 5.2.8 ISO 15223-1:2021 Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements
Fragile, handle with care Indicates a medical device that can be broken or damaged if not handled carefully. 5.3.1 ISO 15223-1:2021 Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements
Keep away from sunlight Indicates a medical device that needs protection from light sources. 5.3.2 ISO 15223-1:2021 Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements
Protect from heat and radioactive sources Indicates a medical device that needs protection from heat and radioactive sources. 5.3.3 ISO 15223-1:2021 Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements
Keep dry Indicates a medical device that needs to be protected from moisture. 5.3.4 ISO 15223-1:2021 Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements
Lower limit of temperature Indicates the lower limit of temperature to which the medical device can be safely exposed. 5.3.5 ISO 15223-1:2021 Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements
Upper limit of temperature Indicates the upper limit of temperature to which the medical device can be safely exposed. 5.3.6 ISO 15223-1:2021 Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements
Temperature limits Indicates the temperature limits to which the medical device can be safely exposed. 5.3.7 ISO 15223-1:2021 Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements
Humidity limitation Indicates the range of humanity to which the medical device can be safely exposed. 5.3.8 ISO 15223-1:2021 Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements
Atmospheric pressure limit Indicates the range of humidity to which the medical device can be safely exposed. 5.3.9 ISO 15223-1:2021 Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements
Biological risks Indicates that there are potential biological risks associated with the medical device. 5.4.1 ISO 15223-1:2021 Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements
Do not re-use Indicates a medical device that is intended for one single use only. 5.4.2 ISO 15223-1:2021 Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements
Consult instructions for use or consult electronic instructions for use Indicates the need for the user to consult the instructions for use 5.4.3 ISO 15223-1:2021 Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements
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. 5.4.4 ISO 15223-1:2021 Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements
Contains or presence of natural rubber latex Indicates the presence of natural rubber or dry natural rubber latex as a material of construction within the medical device or the packaging of a medical device 5.4.5 ISO 15223-1:2021 Medical devices –
Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements
Not made with natural rubber latex Not made with natural rubber latex. Annex B ISO 15223-1:2021 Medical devices –
Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements
Importer Indicates the entity importing the medical device into the
locale.
5.1.8 ISO 15223-1:2021 Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements
Patient number Indicates a unique number associated with an individual patient. 5.7.1 ISO 15223-1:2021 Medical devices –
Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements
Single patient multiple use Indicates a medical device that may be used multiple times (multiple procedures) on a single patient 5.4.12 ISO 15223-1:2021 Medical devices –
Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements
Medical device Indicates the item is a medical device. 5.7.7 ISO 15223-1:2021 Medical devices –
Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements
MR Unsafe An item which poses unacceptable risks to the patient,
medical staff, or other persons within the MR environment.
Fig. 10 ASTM F2503-23 Standard Practice
for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
Change identifier Indicates changes to a section in the Instructions for Use
since previous revision.
Annex I, Chapter III, 23.4(y) EU MDR 2017/745
Prescription only Caution: Federal (US) law restricts this device to sale by or on the order of a physician. (b)(1) 21 CFR 801.109
European conformity CE mark indicates that a product has been assessed to
meet EEA safety, health and environmental protection requirements.