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SYMBOLS GLOSSARY

Graphic of the Symbol Standard From Which the Symbol was Referenced Reference Registration Number Symbol Title Symbol Description
ISO 7010 P002 No smoking To prohibit smoking.
ISO 7010 P003 No open flame; Fire, open ignition source and smoking prohibited To prohibit smoking and all forms of open flame.
NA NA No smoking/ No vaping No smoking or no vaping when operating the device.
ISO 7010 M002 Refer to instruction manual/booklet To signify that the instruction manual/ booklet must be read.
ISO 7000 / ISO 15223-1 2620 / 5.3.8 Humidity limitation Indicates the range of humidity to which the medical device can be safely exposed.
The humidity limitation shall be indicated adjacent to the upper and lower horizontal lines.
ISO 60417 5333 Type BF applied part To identify a type BF applied part complying with IEC 60601 -1.
Note 1 - B = Body.
Note 2 - F = Floating applied part.
ISO 60417 5172 Class II equipment To identify equipment meeting the safety requirements specified for Class II equipment according to IEC 61140.
Note - The position of the double-square symbol shall be such that it is obvious that the symbol is part
of the technical information and can in no way be confused with the manufacturer's name or other identifications.
ISO 7000 / ISO 15223-1 2492 / 5.1.5 Batch code

To identify the manufacturer's batch or lot code, for example on a medical device or the corresponding packaging. The code shall be placed adjacent to the symbol.

Indicates that manufacturer's batch code so that the batch or lot can be identified.

ISO 7000 / ISO 15223-1 0626 / 5.3.4 Keep away from rain / Keep dry

To indicate that the transport package shall be kept away from rain and in dry conditions.

Indicates a medical device that needs to be protected from moisture.

Note - This symbol should be used in the orientation shown.
ISO 7000 / ISO 15223-1 0621 / 5.3.1 Fragile; handle with care

To indicate that the contents of the transport package are fragile and the package shall be handled with care.

Indicates a medical device that can be broken or damaged if not handled carefully.

Note - This symbol should be used in the orientation shown.
ISO 7010 W001 General warning sign To signify a general warning.
Note - This safety sign cannot be used on its own and requires a supplementary sign to give further
information about the hazard.
ISO 7000 / ISO 15223-1 0434A / 5.4.4 Caution To indicate that caution is necessary when operating the device or control close to where the symbol is placed, or to indicate that the current situation needs operator awareness or operator action in order to avoid undesirable consequences.
ISO 15223-1 5.1.2  Authorized representative in the European Community / European Union Indicates the authorized representative in the European Community / European Union.

This symbol shall be accompanied by the name and address of the authorized representative, adjacent to the symbol.

NOTE 1 This symbol is used to indicate information that is required in the European Community / European Union. 

NOTE 2 Additional guidance can be found in ISO 20417, ISO 18113-1, ISO 18113-2, ISO 18113-3, ISO 18113-4, and ISO 18113-5

NOTE 3 If multiple symbols (i.e. Authorized Representative, Importer, Distributor, Translation, or Repackaging) identify the same responsible entity, the name and address need not be duplicated, and all applicable symbols can be grouped together next to the single address.
ISO 7000 / ISO 15223-1  2499 / 5.2.1  Sterile Indicates a medical device that has been subjected to a sterilization process.

Note:
• To be used when interior packaging is sterilized by multiple methods (e.g., a kit which contains multiple items sterilized using different methods).
ISO 7000 / ISO 15223-1 2493 / 5.1.6 Catalogue number

To identify the manufacturer’s catalogue number, for example on a medical device or the corresponding packaging. The catalogue number shall be placed adjacent to the symbol.

Indicates the manufacturer's catalogue number so that the medical device can be identified.

ISO 15223-1 3-1,5.7.10 Unique device identifier Indicates a carrier that contains Unique Device Identifier information.
This symbol may be used when multiple data carriers are present on the label. If used, this symbol shall be placed adjacent to the Unique Device Identifier carrier.
Note 1 - This symbol identifies the UDI carrier, including the AIDC and human readable information.
Note 2 - This symbol is defined in ISO 15223-1:2021, 5.7.10.
ISO 7000 / ISO 15223-1 2497 / 5.1.3 Date of manufacture To indicate the date on which a product was manufactured.
Note - The date can be a year, year and month, or year, month, day. The date shall be placed adjacent to the symbol. The date may for example be given as follows: 1996-06-12.
ISO 7000 / ISO 15223-1 3082 / 5.1.1 Manufacturer

To identify the manufacturer of a product. This symbol shall be used filled in all applications to differentiate it from ISO 7000-2497.

Indicates the medical device manufacturer.

Note - Symbol is accompanied, adjacent to the symbol, by the name and, when applicable, the address of the manufacturer.
ISO 7000 / ISO 15223-1 2607 / 5.1.4 Use by date

To indicate that the device should not be used after the date accompanying the symbol, for example on a medical device or its packaging.

Indicates the date after which the medical device is not to be used.

Note - The expiration date can be a year, year and month, or year, month, day. The date shall be shown adjacent to the symbol. The date may for example be given as follows: 1997-06-12.
ISO 7000 / ISO 15223-1 2608 / 5.2.6   Do not re-sterilize Indicates a medical device that is not to be re-sterilized.

This symbol is only to be used where there is an accompanying Sterile symbol (5.2.1 to 5.2.5 or 5.2.10).

This symbol is not to be used on reusable medical devices that are intended to be sterilized between uses. 
ISO 7000 / ISO 15223-1 2498 / 5.1.7 Serial number

To identify the manufacturer’s serial number, for example on a medical device or its packaging. The serial number shall be placed adjacent to the symbol.

Indicates the manufacturer’s serial number so that a specific medical device can be 
identified.

IEC 60417 / ISO 15223-1 6050 / 5.1.10 Model Number Indicates the model number or type number of a product.
ISO 7000 / ISO 15223-1 2606 / 5.2.8  Do not use if package is damaged and consult instructions for use.  Indicates that a medical device that should not be used if the package has been damaged or opened and that the user should consult the instructions for use for additional information.

NOTE 1 This symbol can also mean "Do not use if the product sterile barrier system or its packaging is compromised. 

NOTE 2 For product that do not have instructions for use, the recommendation to consult them does not apply.
ISO 7000 / ISO 15223-1 3724 / 5.1.9 Distributor

 Indicates the entity distributing the medical device into the locale.

This symbol shall be accompanied by the name and address of the distributing entity adjacent to the symbol.

ISO 7000 / ISO 15223-1 3725 / 5.1.8 Importer

 Indicates the entity importing the medical device into the locale.

This symbol shall be accompanied by the name and address of the importing entity 
adjacent to the symbol.

IEC 60417 / ISO 15223-1 6049 / 5.1.11 Country of manufacture

To identify the country of manufacture of products.

In the application of this symbol, the “CC” shall be replaced by either the two-letter country 
code or the three letter country code defined in ISO 3166-1. The date of manufacture may be added adjacent to this symbol.

IEC 60417 5031 Direct current To indicate on the rating plate that the equipment is suitable for direct current ONLY; to identify relevant terminals.
ISO 7000 2760 Product information; Information point To Identify a place where information may be found, especially in an emergency.
ISO 7000 717 Call for maintenance To indicate that the assistance of a servicing engineer should be obtained before further operation of the machine is attempted.
2012/19/EU- Waste Electrical and Electronic Equipment (WEEE) NA

Waste Electrical and Electronic Equipment (WEEE)

Waste stream disposal status

This device contains electrical and/or electronic equipment that must be recycled per EU Directive 2012/19/ EU- Waste Electrical and Electronic Equipment (WEEE)
21 CFR Part 801.109 109(b)(1), 15(c)(1)(i)(F)
Rx Only U.S. federal law restricts this device to sale by or on the order of a physician
IEC 62570 7.3.3 MR Unsafe To identify an item which poses unacceptable risks to the patient, medical staff or other persons within the MR environment. When color reproduction is not practical, the symbol may be printed in black and white. The use of the colored version is strongly encouraged for the added visibility and information provided by the color.
ISO 7000 / ISO 15223-1 0632 / 5.3.7 Temperature limit

To indicate the maximum and minimum temperature limits at which the item shall be stored, transported or used.

Indicates the temperature limits to which the medical device can be safely exposed.

Note - The temperature values may be indicated adjacent to the symbol with the minimum temperature at the lower left and the maximum temperature at the upper right.
IEC 60529 NA Ingress Protection Rating Protected from touch by fingers and objects greater than 0.5 in (12.5 mm).
Protected from dripping water less than 15 degrees from vertical.
ISO 7000 / ISO 15223-1  1641 / 5.4.3  Consult instructions for use or consult electronic instructions for use Indicates the need for the user to consult the instructions for use. 

NOTE 1 Synonym for "Consult instructions for use" is "Consult operating instructions." 

NOTE 2 See also ISO 20417 and the safety sign ISO 7010-M002.

NOTE 3 See A.16 for examples and for use in directing users to consult the electronic instructions for use.

 

 

ISO 7000 / ISO 15223-1  2725 / 5.4.5  

Contains or presence of natural rubber latex

Indicates the presence of dry natural rubber or  natural rubber latex as a material of construction within the medical device or the packaging of a medical device.

NOTE This symbol is intended to warn those people who can have allergic reactions to certain latex proteins. 

This symbol should not be used for medical devices containing "synthetic rubber."
IEC 60417 6089A Menu invocation key (Drop down Menu) Alternative graphical representation.
ISO 7000 / ISO 15223-1 2609 / 5.2.7 Non-sterile

To indicate that the device that is normally provided sterile in the same or similar packaging has not been sterilized.

Indicates a medical device that has not been subjected to a sterilization process.

Note - The symbol is also used to indicate that a device that the manufacturer intends to be sterilized has not yet been through the sterilization process.

 

 

Directive 93/68/EEC

 

 

European Medical Device Regulation 2017/745

Article 20 and Annex V

European conformity 

CE Marking

Signifies European conformity (CE) mark  

CE Marking on a product is a manufacturer's declaration that the product complies with the essential requirements of the relevant European health, safety and environmental protection legislation.

Indicates conformity with applicable European Union medical device requirements. The identification number identifies the Notified Body involved in the applicable conformity assessment procedure.

NA NA Quantity  Indicates quantity of medical devices contained within the packaging. 
ISO 15223-1 5.7.7 Medical Device Indicates the item is a medical device.
ISO 7000 623 This way up To indicate correct upright position of the transport package.
ISO 7000 2403 Stacking limit by number To indicate that the items shall not be vertically stacked beyond the specified number, either because of the nature of the transport packaging or because of the nature of the items themselves. Note 1 - Replace "n" with the maximum number of items allowed.
Note 2 - Number "n" does not include the bottom package in the stack.
Note 3 - This symbol shall be used in the orientation shown.
Note 4 - This symbol was revised on 201 4-06-05.
ISO 7000 P069 Not to be serviced by users To prohibit carrying out servicing by users.
ISO 7000 / ISO 15223-1 0624 / 5.3.2 Keep away from sunlight

To indicate that transport package shall not be exposed to sunlight.

Indicates a medical device that needs protection from light sources.

ISO 7000 / ISO 15223-1 2621 / 5.3.9 Atmospheric pressure limitation

To indicate the acceptable upper and lower limits of atmospheric pressure for transport and storage.

Indicates the range of atmospheric pressure to which the medical device can be safely exposed.

IEC60417 5032 Alternating current To indicate on the rating plate that the equipment is suitable for alternating current only; to identify relevant terminals
IEC 60417 5010 "ON"/"OFF" (push-push)  To indicate connection to or disconnection
from the mains, at least for mains switches or their positions, and all those cases where safety is involved.
IEC 60417 N/A   Power Off Switch
ISO 7000 / ISO 15223-1 1051 / 5.4.2 Do no re-use Indicates a medical device that is intended for one single use only

NOTE Synonyms for "Do not re-use" are "single use" and "use only once."
ISO 7000 / ISO 15223-1 3706 / 5.4.12 Single patient multiple use Indicates a medical device that may be used multiple times (multiple procedures) on a single patient.
IEC60417 5957 For indoor use only To identify electrical equipment designated primarily for indoor use. 
IEC 60878 / IEC 60601-1 / IEC 60417 5335 Type CF applied part To identify a type CF applied part complying with IEC 60601-1
IEC 60417 5840 Type B applied part On medical equipment. To identify a type B applied part complying with IEC 60601-1
IEC 60417 5021 Equipotentiality To identify the terminals which, when connected together, bring the various parts of an equipment or of a system to the same potential, not necessarily being the earth (ground) potential, e.g. for local bonding. 
ISO 7000 / IEC 60417 NA Packaging Unit To indicate the number of pieces in the package.
ISO 7000 / ISO 15223-1 3727 / 5.7.9 Repackaging

Indicates that a modification to the original medical device packaging configuration has 
occurred.

This symbol shall be accompanied by the name and address of the entity that is responsible for the repackaging activity adjacent to the symbol.

ISO 7000 / ISO 15223-1 0615 / 5.3.3 Protect from heat and radioactive sources

Indicates a medical device that needs protection from heat and radioactive sources.

ISO 7010 M001 General Mandatory Action Sign

 To signify a mandatory action.

IEC 60417 5140 Non-ionizing electromagnetic radiation

To indicate generally elevated, potentially hazardous, levels of non-ionizing 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.

United States Code of Federal Regulations Title 47 Part 15.19 FCC Mark

To indicate that electromagnetic radiation from the device stays below limits set by the Federal Communications Commission.

CSA International NA CSA Mark

CSA - Canadian Standards Association. Indicates that the product was tested and has met the certification requirements for electrical, plumbing and/or mechanical products.

The “C” and “US” indicators adjacent to the CSA Mark signify that the product has been evaluated to the applicable CSA and ANSI/UL.

ISO 7010 W021 Warning; Flammable Material

To warn of flammable material.

ISO 7010 W023 Corrosive Substance

To warn of a corrosive substance.

ISO 7000 / ISO 15223-1 0534 / 5.3.5 Lower limit of temperature

Indicates the lower limit of temperature to which the medical device can be safely exposed.

The lower limit of temperature shall be indicated adjacent to the lower horizontal line.

ISO 7000 / ISO 15223-1 0533 / 5.3.6 Upper limit of temperature

Indicates the upper limit of temperature to which the medical device can be safely exposed.

The upper limit of temperature shall be indicated adjacent to the upper horizontal line.

IEC 60417 5009 Stand-by

To identify the switch or switch position by means of which part of the equipment is switched on in order to bring it into the stand-by condition, and to identify the control to shift to or to indicate the state of low power consumption. Each of different states of power consumption may be indicated using a corresponding color.