Symbols
Symbol | Title | Standard* | Description |
---|---|---|---|
Manufacturer | ISO-15223-1 Medical devices — Symbols to be used with information to be supplied by the manufacturer | Indicates the medical device manufacturer. | |
Authorized representative in the European Community/European Union | ISO 15223-1 Medical devices – Symbols to be used with medical device labels – General requirements | Indicates the Authorized representative in the European Community/European Union. | |
Date of Manufacture | ISO-15223-1 Medical devices — Symbols to be used with information to be supplied by the manufacturer | Indicates the date when the medical device was manufactured. | |
Use-By Date | ISO-15223-1 Medical devices — Symbols to be used with information to be supplied by the manufacturer | Indicates the date after which the medical device is not to be used. | |
Batch Code | ISO-15223-1 Medical devices — Symbols to be used with information to be supplied by the manufacturer | Indicates the manufacturer’s batch code so that the batch or lot can be identified. | |
Catalogue Number | ISO-15223-1 Medical devices — Symbols to be used with information to be supplied by the manufacturer | Indicates the manufacturer’s catalogue number so that the medical device can be identified. | |
Serial Number | ISO-15523-1 Graphical symbols for use on equipment – Registered | Indicates the manufacturer’s serial number so that a specific medical device can be identified. | |
Non-Sterile | ISO-15223-1 Medical devices — Symbols to be used with information to be supplied by the manufacturer | Indicates a medical device that has not been subjected to a sterilization process | |
Do not use if package is damaged and consult instructions for use | ISO-15223-1 Medical devices — Symbols to be used with information to be supplied by the manufacturer | Indicates that the medical device that should not be used if the package has been damaged or opened and that the user should consult the instructions use for additional information. | |
Fragile, handle with care | ISO-15223-1 Medical devices — Symbols to be used with information to be supplied by the manufacturer | Indicates a medical device that can be broken or damaged if not handled correctly. | |
Keep away from sunlight | ISO-15223-1 Medical devices — Symbols to be used with information to be supplied by the manufacturer | Indicates a medical device that needs protection from heat and radioactive sources. | |
Keep dry | ISO-15223-1 Medical devices — Symbols to be used with information to be supplied by the manufacturer | Indicates a medical device that needs to be protected from moisture. | |
Lower limit of temperature | ISO-15223-1 Medical devices — Symbols to be used with information to be supplied by the manufacturer | Indicates the lower limit of temperature to which the medical device can be safely exposed. | |
Upper limit of temperature | ISO-15223-1 Medical devices — Symbols to be used with information to be supplied by the manufacturer | Indicates the upper limit of temperature to which the medical device can be safely exposed. | |
Temperature limit | ISO-15223-1 Medical devices — Symbols to be used with information to be supplied by the manufacturer | Indicates the temperature limits to which the medical device can be safely exposed. | |
Do not re-use | ISO-15223-1 Medical devices — Symbols to be used with information to be supplied by the manufacturer | Indicates a medical device that is intended for single use only. | |
Consult instructions for use or consult electronic instructions for use | ISO-15223-1 Medical devices — Symbols to be used with information to be supplied by the manufacturer | Indicates the need for the user to consult the instructions for use. | |
Caution | ISO-15223-1 Medical devices — Symbols to be used with information to be supplied by the manufacturer | Indicates that caution is necessary when operating the device or control close to where the symbol is placed, or the current situation needs operator awareness or operators’ action in order to avoid undesirable consequences. | |
Alternating Current | IEC 60417 Graphical symbols for use on equipment | To indicate on the rating plate that the equipment is suitable for alternating current only; to identify relevant terminals. | |
Direct current | IEC 60417 Graphical symbols for use on equipment | To indicate on the rating plate that the equipment is suitable for direct current only; to identify relevant terminals. | |
Both direct and alternating current | IEC 60417 Graphical symbols for use on equipment | To indicate on the rating plate that the equipment is suitable for both direct and alternating current (universal); to identify relevant terminals. | |
Class II equipment | IEC 60417 Graphical symbols for use on equipment | To identify equipment meeting the safety requirements specified for Class II equipment according to IEC 61140. | |
Type BF applied part | IEC 60417 Graphical symbols for use on equipment | To identify a type BF applied part complying with IEC 60601-1. | |
General Warning Sign | ISO 7010 Graphical symbols – Safety colours and safety signs – Registered safety signs | To signify a general warning. | |
TUV Notified Body Number | This Product is in conformity with European Medical Directive 93/42 EEC. This has been verified by a notified body. | ||
Conformité Européene or European Conformity | Council Directive 93/42/EEC of 14 June 1993 concerning medical devices | Indicates manufacturer declaration that the product complies with the essential requirements of the relevant European health, safety and environmental protection legislation. | |
Symbols to be used with medical device labels, labeling, and information to be supplied | ISO 15223-1 | Indicates the item is a medical device. | |
Prescription Use Only | Caution: Federal law (USA) restricts this device to sale by or on the order of a licensed healthcare practitioner. | ||
Warning; Laser beam | ISO 7010 | To warn of a laser beam. | |
Wireless signal level, very strong signal | IEC 60417 | To indicate that the wireless signal level is very high. | |
For indoor use only | IEC 60417 | To identify electrical equipment designed primarily for indoor use. | |
Wear eye protection | ISO 7010 | To signify that eye protection must be used. | |
Wearing protective gloves | ISO 7010 | To signify that protective gloves must be worn. | |
Collect separately | DIRECTIVE 2012/19/ EU | Separate collection for waste of electrical and electronic equipment. Do not dispose of battery in municipal waste. The symbol indicates separate collection for battery is required. | |
Federal Communications Commission | 21 CFR Part 15 | Meets FCC requirements per 21 CFR Part 15. | |
ETL Listed Mark | The ETL Mark is proof of product compliance to North American safety standards. DenMat’s ETL Mark comes from Intertek Testing Services, Inc. | ||
Internal Symbol | Do not use in the presence of flammable substances | ||
Laser aperture at end of handpiece | Internal Symbol | ||
Caution: Do not wind clockwise | Internal Symbol | ||
Caution, risk of electric shock | EC 60417 — Graphical Symbols for Use on Equipment | To identify equipment, for example, the welding power source, that has risk of electric shock. | |
Warning; Hot surface | ISO 7010 — Graphical symbols — Safety colours and safety signs — Registered safety signs | To warn of a hot surface | |
Lamp; lighting; illumination | IEC 60417 — Graphical Symbols for Use on Equipment | To identify switches which control light sources, e.g. room lighting, lamp of a film projector, dial illumination of a device. | |
Fuse | IEC 60417 — Graphical Symbols for Use on Equipment | To identify fuse boxes or their location. | |
Distributor | ISO 15223-1 Medical devices — Symbols to be used with information to be supplied by the manufacturer — Part 1: General requirement | To indicate the entity distributing the medical device into the locale | |
Li-Ion Battery | Internal Symbol | To indicate that a Lithium battery must be recycled |
*All standards listed are assumed to be the latest revision unless otherwise specified.