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SYMBOLSYMBOL TITLEDESCRIPTIONSTANDARD TITLE & DESIGNATION NUMBERREFERENCE NUMBER
Date of ManufactureDate of ManufactureIndicates the date when the medical device was manufactured.ISO & ANSI/AAMI/ISO 15223-1 Medical devices-Symbols to be used with medical device labels- General requirements.5.1.3
ManufacturerManufacturerIndicates the medical device manufacturer, as defined in EU Directives 90/385/EEC, 93/42/ EEC and 98/79/EC.ISO & ANSI/AAMI/ISO 15223- Medical devices-Symbols to be used with medical device labels- General requirements.5.1.1
Authorized representative in the European communityAuthorized representative in the European communityIndicates the Authorized Representative in the European Community.ISO & ANSI/AAMI/ISO 15223-1 Medical devices-Symbols to be used with medical device labels- General requirements.5.1.2
Conformité Européene (European Conformity)CE Marking on a product is a manufacturer’s declaration that the product complies with the essential requirements of the relevant European health, safety and environmental protection legislation.Directive 93/68/EEC.N/A
Reorder NumberIndicates the manufacturer’s catalogue number so that the medical device can be identified.ISO & ANSI/AAMI/ISO 15223-1 Medical devices-Symbols to be used with medical device labels- General requirements.5.1.6
Serial NumberIndicates the manufacturer’s serial number so that a specific medical device can be identifiedISO & ANSI/AAMI/ISO 15223-1 Medical devices-Symbols to be used with medical device labels- General requirements.5.1.7
Batch CodeIndicates the manufacturer’s batch code so that the batch or lot can be identified.ISO & ANSI/AAMI/ISO 15223-1 Medical devices-Symbols to be used with medical device labels- General requirements.5.1.5
Refer to instruction manual/bookletTo signify that the instruction manual/booklet must be read.ISO 7010-Graphical Symbols-Safety Colors and Safety Signs-Registered Safety SignsISO 7010-M002
Consult Instructions for UseIndicates the need for the user to consult the Instructions for Use.ISO & ANSI/AAMI/ISO 15223-1 Medical devices-Symbols to be used with medical device labels- General requirements.5.4.3
General mandatory action signTo signify a mandatory actionISO 7010-Graphical Symbols-Safety Colors and Safety Signs-Registered Safety SignsISO 7010-M001
MR SafeAn item that poses no known hazards resulting from exposure to any MR environment. MR Safe items are composed of materials that are electrically non-conductive, nonmetallic and nonmagnetic.ASTM F2503 – 13 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment7.3.1
MR 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 Environment7.3.2
MR UnsafeMR UnsafeAn item which poses unacceptable risks to the patient, medical staff or other persons within the MR environment.ASTM F2503 – 13 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment7.3.3
CautionCautionIndicates 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 & ANSI/AAMI/ISO 15223-1 Medical devices-Symbols to be used with medical device labels-General requirements.5.4.4
General warning signGeneral warning signTo signify a general warningISO 7010-Graphical Symbols-Safety Colors and Safety Signs-Registered Safety SignsISO 7010-W001
Warning; ElectricityWarning; ElectricityTo warn of electricityISO 7010-Graphical Symbols-Safety Colors and Safety Signs-Registered Safety SignsISO 7010-W012
Do Not ReuseDo Not ReuseIndicates a medical device that is intended for one use or for use on a single patient during a single procedure.ISO & ANSI/AAMI/ISO 15223-1 Medical devices-Symbols to be used with medical device labels-General requirements.5.4.2
Protective Insulation- Devices of Protection Class IIProtective Insulation: Devices of Protection Class IlTo identify equipment meeting the safety requirements specified for Class II equipment.ISO 7010-Graphical Symbols-Safety Colors and Safety Signs-Registered Safety SignsIEC 60417-5172
Waste Electrical
and Electronic
Equipment
Directive (WEEE)Waste Electrical and Electronic Equipment Directive (WEEE)Waste products should not be disposed of with household waste. e.g. at a local authority collection point.Waste Electrical and Electronic Equipment Directive (WEEE)RoHS Directive 2002/96/EC
Type BF Applied
PartType BF Applied PartOn medical equipment. To identify a type BF applied part complying with IEC 60601-1.IEC 60417 – Graphical Symbols for Use on EquipmentIEC 60417-5333
Type B Applied PartType B Applied PartOn medical equipment. To identify a type B applied part complying with IEC 60601-1.IEC 60417 – Graphical Symbols for Use on EquipmentIEC 60417-5840
Keep DryKeep DryIndicates a medical device that needs to be protected from moisture.ISO & ANSI/AAMI/ISO 15223-1 Medical devices-Symbols to be used with medical device labels-General requirements.5.3.4
Fragile, handle
with careFragile, handle with careIndicates a medical device that can be broken or damaged if not handled carefully.ISO & ANSI/AAMI/ISO 15223-1 Medical devices-Symbols to be used with medical device labels-General requirements.5.3.1
This Way UpThis Way UpTo indicate correct upright position of the transport package.ISO 7000 – Graphical symbols for use on equipment – Registered symbolsISO 7000-6023
Temperature LimitTemperature LimitTo indicate the maximum and minimum temperature limits at which the item shall be stored, transported or used.ISO 7000 – Graphical symbols for use on equipment – Registered symbolsISO 7000-6032
QuantityQuantityIndicates quantity of medical devices contained within the packaging.N/AN/A
Purchase OrderPurchase OrderIndicates the Customer Purchase Order Number for the purchase of the medical device contained within the packaging.N/AN/A