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Labeling As Per En Iso

Medical Device Regulations place great importance on information supplied by a manufacturer to the user so as to ensure the safe and effective use of a medical device. This can be seen being cascaded down into ISO 13485:2016 whereby labelling comprises of the label, the instructions for use, and any other information that is related to identification, technical description, intended purpose and proper use of the medical device.

In order to be in compliance, the usage of standards such EN ISO 15223-1 in conjunction with other recognized harmonized standards (both horizontal & vertical) need to be considered together with emerging requirement on unique device identification (UDI). These requirements vary in different regulated jurisdictions. Mistakes in labeling strategy may result in rejection during market authorization or even prosecution and/or penalties.

If your company manufactures medical devices, or medical related equipment, and IVDs then you will definitely need the EN ISO 15223-1 medical symbols for labelling your products Worldwide.

By applying these harmonized symbols you need no further textual explanation on the packaging of your product.

EN ISO 15223-1 has been listed as a harmonized standard in Europe under the Medical Devices Directive.

The Medical Devices Directive has designated EN ISO 15223-1as the standard providing labeling symbols for all medical devices, and is currently the only labeling standard for medical devices listed in the EU official journal.

Note that EN ISO 15223-1 is essentially the same standard as ISO 15223-, which in its turn is identical to ANSI/AAMI 15223-1. These symbols may also be applied for In Vitro Diagnostic devices.

Available symbols

Some General symbol as per EN ISO 15223-1 are given below.

Sr No. Symbol Name Symbol Description
1. Manufacturer Indicates the medical device manufacturer
2. Authorized representative in the European Community Indicates the Authorized representative in the European Community.
3. Date of manufacture Indicates the date when the medical device was manufactured.
4. Use-by date Indicates the date after which the medical device is not to be used.
5. Batch code Indicates the manufacturer’s batch code so that the batch or lot can be identified.
6. Catalogue number Indicates the manufacturer’s catalogue number so that the medical device can be identified.
7. Serial number Indicates the manufacturer’s serial number so that a specific medical device can be identified.
8. Sterile Indicates a medical device that has been subjected to a sterilization process.
9. Sterilized using aseptic processing techniques Indicates a medical device that has been manufactured using accepted aseptic techniques.
10. Sterilized using ethylene oxide Indicates a medical device that has been sterilized using ethylene oxide.
11. Sterilized using irradiation Indicates a medical device that has been sterilized using irradiation.
12. Sterilized using steam or dry heat Indicates a medical device that has been sterilized using steam or dry heat.
13. Do not resterilize Indicates a medical device that is not to be resterilized.
14. Non-sterile Indicates a medical device that has not been subjected to a sterilization process.
15. Do not use if package is damaged Indicates a medical device that should not be used if the package has been damaged or opened.
16. Fragile, handle with care Indicates a medical device that can be broken or damaged if not handled carefully.
17. Keep away from sunlight Indicates a medical device that needs protection from light sources.
18. Keep dry Indicates a medical device that needs to be protected from moisture.
19. Lower limit of temperature Indicates the lower limit of temperature to which the medical device can be safely exposed.
20. Upper limit of temperature Indicates the upper limit of temperature to which the medical device can be safely exposed.
21. Temperature limit Indicates the temperature limits to which the medical device can be safely exposed.
22. Humidity limitation Indicates the range of humidity to which the medical device can be safely exposed.
23. Atmospheric pressure limitation Indicates the range of atmospheric pressure to which the medical device can be safely exposed.
24. 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.
25. Consult instructions for use Indicates the need for the user to consult the instructions for use.
26. 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.
27. Contains or 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

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