The following symbols are present in ISO 15223-1 (Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied)
Symbol | Title | Reference No. | Meaning |
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Manufacturer | 5.1.1 | Name and address of the manufacturer. | |
Use By Date | 5.1.4 | Do not use after date. | |
Batch Code | 5.1.5 | Manufacturer’s batch/lot code. | |
Catalog Number | 5.1.6 | Manufacturer’s catalog number. | |
Serial Number | 5.1.7 | Manufacturer’s serial number. | |
Lower limit of temperature | 5.3.5 | Indicates the lower limit of temperature to which the medical device can be safely exposed. | |
Temperature limit | 5.3.7 | Indicates the temperature limits to which the medical device can be safely exposed. | |
Do not re-use | 5.4.2 | Indicates medical device is intended for one use. | |
Consult the instructions for use | 5.4.3 | Indicates the need for the user to consult the instructions for use. | |
Caution | 5.4.4 | Indicates the need or the user to consult the instructions for use for important cautionary information. | |
Control | 5.5.2 | Indicates control material. | |
Contains sufficient for tests | 5.5.5 | Indicates the total number of IVD tests that can be performed with kit. | |
In vitro diagnostic medical device | 5.5.1 | Indicates a medical device that is intended to be used as an in vitro diagnostics medical device. | |
Authorized representative in the European Community | 5.1.2 | Name and address of authorized representative in the European Union. | |
Biological risks | 5.4.1 | Indicates that there are potential biological risks associated with medical device. |
Commonly Used Symbols | |||
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Do not put in trash | Annex IX | Recycle electric and electronic waste. Directive 2012/19/EU | |
Contents of kit |