Symbol | Standard/Law Reference | Standard/Law Title | Symbol Title | Explanatory Text |
---|
| ISO 13225-1, Clause 5.1.1 | Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied | Manufacturer | Indicates the medical device manufacturer. |
ISO 7000-3082 | Graphical symbols for use on equipment |
| ISO 15223-1, Clause 5.1.3 | Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied | Date of Manufacture | Indicates the date when the medical device was manufactured. |
ISO 7000-2497 | Graphical symbols for use on equipment |
| EN 60417-6049 | Graphical symbols for use on equipment | Country of Origin | To identify the country of manufacture of products.To identify country abbreviation, see https://www.iso.org/obp/ui/#search. |
ISO 3166-1 | Codes for the representation of names of countries and their subdivisions - Part 1: Country Codes |
| ISO 15223-1, Clause 5.1.2 | Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied | Authorized European Representative | Indicates the Authorized Representative in the European Union |
| ISO 15223-1, Clause 5.1.6 | Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied | Catalogue or model number | Indicates the manufacturer's catalogue number so the device can be identified. |
ISO 7000-2493 | Graphical symbols for use on equipment |
| ISO 15223-1, Clause 5.1.7 | Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied | Serial Number | Indicates the manufacturer's serial number so that a specific device can be identified. |
ISO 7000-2498 | Graphical symbols for use on equipment |
| ISO 15223-1, Clause 5.1.5 | Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied | Batch/Lot Code | Indicates the manufacturer's batch/lot code so that the batch or lot can be identified. |
ISO 7000-2492 | Graphical symbols for use on equipment |
| ISO 15223-1, Clause 5.1.4 | Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied | Use by Date | Indicates the date after which the medical device is not to be used. |
ISO 7000-2607 | Graphical symbols for use on equipment |
| ISO 15223-1, Clause 5.5.1 | Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied | In vitro diagnostic medical device | Indicates that a medical device is intended to be used as an in vitro diagnostic medical device. |
| ISO 15223-1, Clause 5.4.4 | Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied | 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. |
IEC 60601-1, Table D.1, Symbol 10 | Medical electrical equipment - Part 1:General requirements for basic safety and essential performance |
ISO 7000-0434 | Graphical symbols for use on equipment |
| ISO 15223-1, Clause 5.3.7 | Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied | Temperature Limit | Indicates the temperature limits to which the medical device can be safely exposed. |
ISO 7000-0632 | Graphical symbols for use on equipment |
| ISO 15223-1, Clause 5.3.8 | Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied | Humidity Limitation | Indicates the range of humidity to which the medical device can be safely exposed. |
ISO 7000-2620 | Graphical symbols for use on equipment |
| ISO 15223-1, Clause 5.3.4 | Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied | Keep dry | Indicates a medical device needs to be protected from moisture. |
ISO 7000-0626 | Graphical symbols for use on equipment |
| ISO 15223-1, Clause 5.3.1 | Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied | Fragile, handle with care | Indicates a medical device that can be broken or damaged is not handled carefully. |
ISO 7000-0621 | Graphical symbols for use on equipment |
| ISO 15223-1, Clause 5.4.2 | Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied | 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 7000-1051 | Graphical symbols for use on equipment |
| ISO 15223-1, Clause 5.2.6 | Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied | Do not resterilize. | Indicates that a medical device should not be resterilized. |
ISO 7000-2608 | Graphical symbols for use on equipment |
| ISO 15223-1, Clause 5.2.1 | Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied | Sterile | Indicates a medical device that has been subjected to a sterilization process. |
ISO 7000-2499 | Graphical symbols for use on equipment |
| ISO 15223-1, Clause 5.2.2 | Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied | Sterile using aseptic techniques | Indicates medical device that has been sterilized by using accepted aseptic technique. |
ISO 7000-2500 | Graphical symbols for use on equipment |
| ISO 15223-1, Clause 5.2.3 | Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied | Sterilized by ethylene oxide treatment | Indicates a medical device that has been sterilized using ethylene oxide. |
ISO 7000-2501 | Graphical symbols for use on equipment |
| ISO 15223-1, Clause 5.2.4 | Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied | Sterilized using irradiation | Indicates a medical device has been sterilized using irradiation. |
ISO 7000-2502 | Graphical symbols for use on equipment |
| ISO 15223-1, Clause 5.2.5 | Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied | Sterilized using steam or dry heat | Indicates a medical device has been sterilized using steam or dry heat. |
ISO 7000-2503 | Graphical symbols for use on equipment |
| ISO 15223-1, Clause 5.2.9 | Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied | Sterile fluid path | To identify the presence of a sterile fluid path within the medical device when other parts of the medical device are not necessarily supplied sterile. |
ISO 7000-3084 | Graphical symbols for use on equipment |
| ISO 15223-1, Clause 5.3.2 | Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied | Keep away from sunlight | Indicates a medical device that needs protection from light souces. |
ISO 7000-0624 | Graphical symbols for use on equipment |
| ISO 15223-1, Clause 5.2.7 | Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied | Non-sterile | Indicates a medical device that has not been subjected to a sterilization process. |
ISO 7000-2609 | Graphical symbols for use on equipment |
| ISO 15223-1, Clause 5.4.3 | Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied | Consult instructions for use | Indicates user needs to consult instructions for use. |
ISO 7000-1641 | Graphical symbols for use on equipment |
| ISO 7000-3500 | Graphical symbols for use on equipment | Electronic instructions for use | To indicate on product or product packaging that relevant information for use of the product is available in electronic form rather than, or in addition to, printed paper form. |
| IEC 60601-1, Table D.2, Symbol 10 | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance | Refer to instruction manual/booklet | Indicates user needs to consult instructions for use. |
| IEC 60601-1-2:2007, Clause 5.1.1 | Medical electrical equipment — Part 1-2: General requirements for basic safety and essential performance — Collateral standard: Electromagnetic compatibility — Requirements and tests | Non-ionizing electromagnetic radiation | To indicate generally elevated, potentially hazardous, levels of nonionizing radiation, or to indicate equipment or systems e.g. in the medical electrical area that include RF transmitters or that intentionally apply RF electromagnetic energy for diagnosis or treatment. |
IEC 60417-5140 | Graphical symbols for use on equipment |
IEC 60878-5140 | Graphical symbols for electrical equipment in medical practice |
| ISO 15223-1, Clause 5.3.9 | Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied | Atmospheric pressure limits | Indicates the range of atmospheric pressure to which the medical device can be safely exposed. |
ISO 7000-2621 | Graphical symbols for use on equipment |
| ISO 15223-1, Clause 5.6.3 | Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied | Non-pyrogenic | Indicates that the medical device is non-pyrogenic. |
ISO 7000-2724 | Graphical symbols for use on equipment |
| ISO 15223-1, Clause 5.2.8 | Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied | Do not use if package is damaged | Indicates that the medical device should not be used if the package holding device has been damaged or opened. |
ISO 7000-2606 | Graphical symbols for use on equipment |
| ISO 7000-3079 | Graphical symbols for use on equipment | Open here | Indicates where the package can be opened and to indicate method of opening it. |
| ASTM F2503 | Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment | Magnetic Resonance (MR) unsafe | Keep device away from magnetic resonance imaging (MRI) equipment. |
| IS EN-15986:2011 | Symbol for use in the labelling of medical devices.Requirements for labelling of medical devices containing phthalates. | Contains presence of phthalates | Indicates presence of Bis (2-ethylexyl) phthalate (DEHP). |
| ISO 15223-1, Clause 5.4.5, Annex B.2 | Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied | Does not contain natural rubber latex | The medical device or the packaging of the medical device does not contain natural rubber latex. |
| ISO 15223-1, Clause 5.2.5, Annex B.2 | Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied | Does not contain natural rubber latex | The medical device or the packaging of the medical device does not contain natural rubber latex. |
| ISO 15223-1, Clause 5.4.5 | Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied | 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 of a medical device |
| EN 50419 | Marking of Electrical and Electronic Equipment in accordance with Article 11(2) of Directive 2002/96/EC (WEEE). | WEEE Wheeled Bin | This product contains electrical and electronic components that may contain materials which, if disposed with general waste, could be damaging to the environment. Residents of the European Union must follow specific disposal or recycling instructions for this product. Residents outside the European Union must dispose or recycle this product in accordance with local laws or regulations that apply. |
| IEC 60601-1, Table D.1, Symbol 20 | Medical electrical equipment - Part 1:General requirements for basic safety and essential performance | Type BF applied part | Identifies a type BF applied part complying with IEC 60601-1. |
ISO 7000-5333 | Graphical symbols for use on equipment |
| IEC 60601-1, Table D.1, Symbol 19 | Medical electrical equipment - Part 1:General requirements for basic safety and essential performance | Type B applied part | Identifies a type B applied part complying with IEC 60601-1. |
ISO 7000-5840 | Graphical symbols for use on equipment |
| IEC 60601-1, Table D.3, Symbol 2 | Medical electrical equipment - Part 1:General requirements for basic safety and essential performance | Degrees of ingress protection provided by enclosure | Manufacturer-determined degree of particle and water ingress where N1=degree of protection from particles (scale of 0-6) and N2=degree of protection from water (scale of 0-8). |
IEC 60529 | Degrees of protection provided by enclosures (IP Code) | NOTE:When a characteristic numeral is not required to be specified, it is replaced by the letter ÒXÓ. |
| IEC 60529 | Degrees of protection provided by enclosures (IP Code) | Degrees of ingress protection provided by enclosure | Protected against solid foreign objects of 12.5mm and greater, and against the effects of continuous immersion in water. |
| IEC 60529 | Degrees of protection provided by enclosures (IP Code) | Degrees of ingress protection provided by enclosure | Protected against solid foreign objects of 1.0mm and greater, and against the effects of continuous immersion in water. |
| IEC 60529 | Degrees of protection provided by enclosures (IP Code) | Degrees of ingress protection provided by enclosure | Protected against the effects of continuous immersion in water. |
| IEC 60529 | Degrees of protection provided by enclosures (IP Code) | Degrees of ingress protection provided by enclosure | Protected against the effects of temporary immersion in water. |
| 21 CFR Part 801.1(c)(1)(i)F | Labeling - Medical devices; prominence of required label statements | Prescription use only. | Requires prescription for sale in the United States and is used in place of the statement below:
Caution: Federal law restricts this device to sale by or on the order of a physician, dentist, or licensed practitioner. |
21 CFR Part 801.109 | Labeling - Prescription devices |
| Directive 93/42/EEC Articles 4, 11, 12, 17 Annex 12 | Council Directive 93/42/EEC of 14 June 1993 concerning medical devices | The requirements for accreditation and market surveillance relating to the marketing of products; Medical Device Directive. | Signifies European technical conformity. |
Directive 93/68/EEC | CE Marking |
| IEC 60417-5172 Section 7.2.6 | Class II equipment | Marking requirements for Class II equpment | Power adaptor meets the safety requirements specified for Class II equipment according to IEC 61140. |
| ISO 7000-2616 | External cord connected | External cord connected | Indicates that device is connected to an external power source. |
| ISO 7000-5008 | OFF (power) | OFF (power) | To indicate disconnection from the power. |
| ISO 7000-5007 | ON (power) | ON (power) | To indicate connection to power. |
| ISO 7000-5417 | Programmable duration | Programmable duration | To identify the control of a programmable timer to start an operation at a specific point in time and to stop the operation at a specific point in time or after a specific duration; or to identify a display of the programmed or to-be-programmed duration. |
| ISO 7000-5546 | Battery check | Battery check | To to identify the battery condition indicator. |
| ISO 7000-0623 | Graphical symbols for use on equipment -- Registered symbols | This way up | To indicate correct upright position of the transport package. |
-
-