SYMBOL | SYMBOL TITLE | DESCRIPTION | STANDARD TITLE & DESIGNATION NUMBER | REFERENCE NUMBER |
---|---|---|---|---|
Date of Manufacture | Indicates 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 | |
Manufacturer | Indicates 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 community | Indicates 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 Number | Indicates 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 Number | Indicates the manufacturer’s serial number so that a specific medical device can be identified | ISO & ANSI/AAMI/ISO 15223-1 Medical devices-Symbols to be used with medical device labels- General requirements. | 5.1.7 | |
Batch Code | Indicates 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/booklet | To signify that the instruction manual/booklet must be read. | ISO 7010-Graphical Symbols-Safety Colors and Safety Signs-Registered Safety Signs | ISO 7010-M002 | |
Consult Instructions for Use | Indicates 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 sign | To signify a mandatory action | ISO 7010-Graphical Symbols-Safety Colors and Safety Signs-Registered Safety Signs | ISO 7010-M001 | |
MR Safe | An 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 Environment | 7.3.1 | |
MR Conditional | An 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 | 7.3.2 | |
MR Unsafe | An 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 Environment | 7.3.3 | |
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. | ISO & ANSI/AAMI/ISO 15223-1 Medical devices-Symbols to be used with medical device labels-General requirements. | 5.4.4 | |
General warning sign | To signify a general warning | ISO 7010-Graphical Symbols-Safety Colors and Safety Signs-Registered Safety Signs | ISO 7010-W001 | |
Warning; Electricity | To warn of electricity | ISO 7010-Graphical Symbols-Safety Colors and Safety Signs-Registered Safety Signs | ISO 7010-W012 | |
Do Not Reuse | Indicates 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 Il | To identify equipment meeting the safety requirements specified for Class II equipment. | ISO 7010-Graphical Symbols-Safety Colors and Safety Signs-Registered Safety Signs | IEC 60417-5172 | |
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 Part | On medical equipment. To identify a type BF applied part complying with IEC 60601-1. | IEC 60417 – Graphical Symbols for Use on Equipment | IEC 60417-5333 | |
Type B Applied Part | On medical equipment. To identify a type B applied part complying with IEC 60601-1. | IEC 60417 – Graphical Symbols for Use on Equipment | IEC 60417-5840 | |
Keep Dry | Indicates 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 care | Indicates 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 Up | To indicate correct upright position of the transport package. | ISO 7000 – Graphical symbols for use on equipment – Registered symbols | ISO 7000-6023 | |
Temperature Limit | To 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 symbols | ISO 7000-6032 | |
Quantity | Indicates quantity of medical devices contained within the packaging. | N/A | N/A | |
Purchase Order | Indicates the Customer Purchase Order Number for the purchase of the medical device contained within the packaging. | N/A | N/A |
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