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Manufacturer |
ISO 7000 Graphical symbols for use on equipment – Registered Symbols |
Reg. No. 3082 |
Indicates the medical device manufacturer, as defined in EU Directives 90/385/EEC,
93/42/EEC and 98/79/EC. |
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Authorized representative in the European Community |
ISO 15223-1 Medical devices – Symbols to be used with medical device labels – General
requirements |
Section 5.1.2 |
Indicates the Authorized representative in the European Community. |
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Date of Manufacture |
ISO 7000 Graphical symbols for use on equipment – Registered Symbols |
Reg. No. 2497 |
Indicates the date when the medical device was manufactured. |
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Use-By Date |
ISO 7000 Graphical symbols for use on equipment – Registered Symbols |
Reg. No. 2607 |
Indicates the date after which the medical device is not to be used. |
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Batch Code |
ISO 7000 Graphical symbols for use on equipment – Registered Symbols |
Reg. No. 2492 |
Indicates the manufacturer’s batch code so that the batch or lot can be identified. |
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Catalogue Number |
ISO 7000 Graphical symbols for use on equipment – Registered Symbols |
Reg. No. 2493 |
Indicates the manufacturer’s catalogue number so that the medical device can be identified. |
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Serial Number |
ISO 7000 Graphical symbols for use on equipment – Registered Symbols |
Reg. No. 2498 |
Indicates the manufacturer’s serial number so that a specific medical device can be
identified. |
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Non-Sterile |
ISO 7000 Graphical symbols for use on equipment – Registered Symbols |
Reg. No. 2609 |
Indicates a medical device that has not been subjected to a sterilization process |
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Do not use if package is damaged |
ISO 7000 Graphical symbols for use on equipment – Registered Symbols |
Reg. No. 2606 |
Indicates a medical device that should not be used if the package has been damaged or
opened. |
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Fragile, handle with care |
ISO 7000 Graphical symbols for use on equipment – Registered Symbols |
Reg. No. 0621 |
Indicates a medical device that can be broken or damaged if not handled correctly. |
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Keep away from sunlight |
ISO 7000 Graphical symbols for use on equipment – Registered Symbols |
Reg. No. 0624 |
Indicates a medical device that needs protection from light sources. |
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Keep dry |
ISO 7000 Graphical symbols for use on equipment – Registered Symbols |
Reg. No. 0626 |
Indicates a medical device that needs to be protected from moisture. |
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Lower limit of temperature |
ISO 7000 Graphical symbols for use on equipment – Registered Symbols |
Reg. No. 0534 |
Indicates the lower limit of temperature to which the medical device can be safely exposed. |
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Upper limit of temperature |
ISO 7000 Graphical symbols for use on equipment – Registered Symbols |
Reg. No. 0533 |
Indicates the upper limit of temperature to which the medical device can be safely exposed. |
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Temperature limit |
ISO 7000 Graphical symbols for use on equipment – Registered Symbols |
Reg. No. 0632 |
Indicates the temperature limits to which the medical device can be safely exposed. |
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Do not re-use |
ISO 7000 Graphical symbols for use on equipment – Registered Symbols |
Reg. No. 1051 |
Indicates a medical device that is intended for one use or for use on a single patient
during a single procedure.
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Consult instructions for use |
ISO 7000 Graphical symbols for use on equipment – Registered Symbols |
Reg. No. 1641 |
Indicates the need for the user to consult the instructions for use. |
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Caution |
ISO 7000 Graphical symbols for use on equipment – Registered Symbols |
Reg. No. 0434A |
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. |
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Alternating Current |
ISO 7000 Graphical symbols for use on equipment – Registered Symbols |
Reg. No. 5032 |
To indicate on the rating plate that the equipment is suitable for alternating current
only; to identify relevant terminals. |
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Direct current |
IEC 60417 Graphical symbols for use on equipment |
Reg. No. 5031 |
To indicate on the rating plate that the equipment is suitable for direct current only; to
identify relevant terminals. |
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Both direct and alternating current |
IEC 60417 Graphical symbols for use on equipment |
Reg. No. 5033 |
To indicate on the rating plate that the equipment is suitable for both direct and
alternating current (universal); to identify relevant terminals. |
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Class II equipment |
IEC 60417 Graphical symbols for use on equipment |
Reg. No. 5172 |
To identify equipment meeting the safety requirements specified for Class II equipment
according to IEC 61140. |
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Type BF applied part |
IEC 60417 Graphical symbols for use on equipment |
Reg. No. 5333 |
To identify a type BF applied part complying with IEC 60601-1. |
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General Warning Sign |
ISO 7010 Graphical symbols – Safety colours and safety signs – Registered safety signs |
Reg. No. W001 |
To signify a general warning. |
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Refer to instruction manual/booklet |
ISO 7010 Graphical symbols – Safety colours and safety signs – Registered safety signs |
Reg. No. M002 |
To signify that the instruction manual/booklet must be read. |
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Conformité Européene
or
European Conformity |
Council Directive 93/42/EEC of 14 June 1993 concerning medical devices |
Article 17 |
Indicates manufacturer declaration that the product complies with the essential
requirements of the relevant European health, safety and environmental protection
legislation. |