Symbols - Henry Schein Orthodontics
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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 (as defined in EU Directives 90/385/EEC, 93/42/EEC and 98/79/EC. 5.1.1 ISO 15223-1:2016 Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General Requirements
Authorized representative in the European Community Indicates the authorized representative in the European Community. 5.1.2 ISO 15223-1:2016 Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General Requirements
Date of manufacture Indicates the date when the medical device was manufactured. 5.1.3 ISO 15223-1:2016 Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General Requirements
Use-by date Indicates the date after which the medical device is not to be used. 5.1.4 ISO 15223-1:2016 Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied – 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 15223-1:2016 Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General Requirements
Catalogue number Indicates the manufacturer’s catalogue number so that the medical device can be identified. 5.1.6 ISO 15223-1:2016 Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied – 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 15223-1:2016 Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General Requirements
Sterile Indicates a medical device that has been subjected to a sterilization process. 5.2.1 ISO 15223-1:2016 Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied – 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 15223-1:2016 Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General Requirements
Sterilized using ethylene oxide Indicates a medical device that has been sterilized using ethylene oxide. 5.2.3 ISO 15223-1:2016 Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General Requirements
Sterilized using irradiation Indicates a medical device that has been sterilized using irradiation. 5.2.4 ISO 15223-1:2016 Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied – 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 15223-1:2016 Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General Requirements
Do not resterilize Indicates a medical device that is not to be resterilized. 5.2.6 ISO 15223-1:2016 Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General Requirements
Non-sterile Indicates a medical device that has not been subjected to a sterilization process. 5.2.7 ISO 15223-1:2016 Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General Requirements
Do not use if package is damaged Indicates a medical device that should not be used if the package has been damaged or opened. 5.2.8 ISO 15223-1:2016 Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General Requirements
Sterile fluid path Indicates the presence of a sterile fluid path within the medical device in cases when other parts of the medical device, including the exterior, might not be supplied sterile. 5.2.9 ISO 15223-1:2016 Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied – 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 15223-1:2016 Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General Requirements
Keep away from sunlight Indicates a medical device that needs protection from light sources. 5.3.2 ISO 15223-1:2016 Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied – 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 15223-1:2016 Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General Requirements
Keep dry Indicates a medical device that needs to be protected from moisture. 5.3.4 ISO 15223-1:2016 Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied – 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 15223-1:2016 Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied – 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 15223-1:2016 Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General Requirements
Temperature limits Indicates the temperature limits to which the medical device can be safely exposed. 5.3.7 ISO 15223-1:2016 Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General Requirements
Humidity limitation Indicates the range of humanity to which the medical device can be safely exposed. 5.3.8 ISO 15223-1:2016 Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied – 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 15223-1:2016 Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General Requirements
Biological risks Indicates that there are potential biological risks associated with the medical device. 5.4.1 ISO 15223-1:2016 Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General Requirements
Do not re-use Indicates a medical device that is intended for one use, or for use on a single patient during a single procedure. 5.4.2 ISO 15223-1:2016 Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General Requirements
Consult instructions for use Indicates the need for the user to consult the instructions for use 5.4.3 ISO 15223-1:2016 Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General Requirements
Caution Indicates the need for the user to consult the instructions for use for important cautionary information such as warnings and precautions that cannot, for a variety of reasons, be presented on the medical device itself. 5.4.4 ISO 15223-1:2016 Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General Requirements
Contains 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 15223-1:2016 Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General Requirements
Sampling site Indicates a medical device or blood processing application that includes a system dedicated to the collection of samples of a given substance stored in the medical device or blood container 5.6.1 ISO 15223-1:2016 Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General Requirements
Fluid path Indicates the presence of a fluid path. 5.6.2 ISO 15223-1:2016 Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General Requirements
Non-pyrogenic Indicates a medical device that is nonpyrogenic 5.6.3 ISO 15223-1:2016 Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General Requirements
Drops per millilitre Indicates the number of drops per millilitre. 5.6.4 ISO 15223-1:2016 Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General Requirements
Liquid filter with pore size Indicates an infusion or transfusion system of the medical device that contains a filter of a particular nominal pore size. 5.6.6 ISO 15223-1:2016 Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General Requirements
One-way valve Indicates a medical device with a valve that allows flow in only one direction. 5.6.6 ISO 15223-1:2016 Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General Requirements
Importer To indicate the entity importing the medical device into the locale.
Patient number Indicates a unique number associated with an individual patient. 5.7.1 ISO 15223-1:2016 Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General Requirements
Single patient multiple use To indicate that the medical device may be used multiple times (multiple procedures) on a single patient
Contains human blood or plasma derivatives To indicate that the medical device contains or incorporates human blood or plasma derivatives 5.4.6 ISO 15223-1:2021 Medical Devices – symbols to be used with information to be supplied by the manufacturer – Part 1: General Requirements
Unique Device Identifier The UDI symbol is optional. When multiple data carrier are present on the label, the symbol may be used. 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
Medical device Indicates that a given product 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
N/A An indication placed at the title of a section within the IFU that information has changed.
Prescription only Caution: Federal (US) law restricts this device to sale by or on the order of a physician. Requirement for medical products sold in the U.S.
European conformity CE marking indicates that a product has been assessed by the manufacturer and deemed to meet EU safety, health and environmental protection requirements. Required for products manufactured anywhere in the world that are then marketed in the EU.