Symbol Glossary

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SymbolSymbol Ref. No.Symbol TitleSymbol DescriptionStandard
5.1.1ManufacturerIndicates the medical device manufacturer, as defined in EU Directives 90/385/EEC, 93/42/EEC and 98/79/EC.ISO 15223-1:2016 Medical Devices – Symbols to Be Used with Medical Device Labels, Labeling, and Information to be Supplied
5.1.2Authorized Representative in the European CommunityIndicates the Authorized Representative in the European Community.ISO 15223-1:2016 Medical Devices – Symbols to Be Used with Medical Device Labels, Labeling, and Information to be Supplied
5.1.4Use-by DateIndicates the date after which the medical device is not to be used.ISO 15223-1:2016 Medical Devices – Symbols to Be Used with Medical Device Labels, Labeling, and Information to be Supplied
5.1.5Batch CodeIndicates the manufacturer's batch code so that the batch or lot can be identified NOTE: Synonyms for "batch code" are "lot number" and "batch number"ISO 15223-1:2016 Medical Devices – Symbols to Be Used with Medical Device Labels, Labeling, and Information to be Supplied
5.1.6Catalogue NumberIndicates the manufacturer's catalog number so that the medical device can be identified NOTE: Synonyms for "catalogue number" are "reference number" and "reorder number"ISO 15223-1:2016 Medical Devices – Symbols to Be Used with Medical Device Labels, Labeling, and Information to be Supplied
5.2.3Sterilized Using Ethylene OxideIndicates a medical device that has been sterilized using ethylene oxide.ISO 15223-1:2016 Medical Devices – Symbols to Be Used with Medical Device Labels, Labeling, and Information to be Supplied
5.2.4Sterilized Using IrradiationIndicates a medical device that has been sterilized using irradiation.ISO 15223-1:2016 Medical Devices – Symbols to Be Used with Medical Device Labels, Labeling, and Information to be Supplied
5.2.6Do Not ResterilizeIndicates a medical device that is not to be resterilized.ISO 15223-1:2016 Medical Devices – Symbols to Be Used with Medical Device Labels, Labeling, and Information to be Supplied
5.2.7Non-SterileIndicates a medical device that has not been subjected to a sterilization process.ISO 15223-1:2016 Medical Devices – Symbols to Be Used with Medical Device Labels, Labeling, and Information to be Supplied
5.2.8Do Not Use if Package is DamagedIndicates a medical device that should not be used if the package has been damaged or opened.ISO 15223-1:2016 Medical Devices – Symbols to Be Used with Medical Device Labels, Labeling, and Information to be Supplied
5.4.2Do Not ReuseIndicates a medical device that is intended for one use, or for use on a single patient during a single procedure.ISO 15223-1:2016 Medical Devices – Symbols to Be Used with Medical Device Labels, Labeling, and Information to be Supplied
5.4.3Consult Instructions for UseIndicates the need for the user to consult the instructions for use.ISO 15223-1:2016 Medical Devices – Symbols to Be Used with Medical Device Labels, Labeling, and Information to be Supplied
5.4.4CautionIndicates 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.ISO 15223-1:2016 Medical Devices – Symbols to Be Used with Medical Device Labels, Labeling, and Information to be Supplied
3.1.11MR ConditionalAn item with demonstrated safety in the MR environment within defined conditions.ASTM F2503-13 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
2725Contains or presence ofOn medical devices: to indicate that the equipment contains the identified product or substance.ISO 7000:2014 Graphical symbols for use on equipment -- Registered symbols
SymbolSymbol TitleSymbol DescriptionAdditional Information
Rx onlyFederal (USA) law restricts this device to sale by or on the order of a physician. An alternative to the text "Rx Only."21 CFR 801.109 Prescription devices
CE MarkingThe product conforms to European Medical Directive 93/42/EEC and meets applicable health, safety and environmental requirements. If the mark is accompanied by a number, conformity is verified by the indicated notified body.Medical Device Directive 93/42/EEC
QuantityIndicates unit quantitySymbol used by A&E Medical Corporation

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