Glossary of Symbols

This section describes the regulatory and safety symbols used in the product labeling.

This glossary provides images of the symbols as presented in the relevant standards, however, some of the symbols may vary in color.

The following is a list of symbols used on the product labeling and their meaning.

ISO 15223-1

Medical devices—symbols to be used with medical device labels, labeling, and information to be supplied.
Part 1: General requirements.

Symbol Standard/Regulation Reference Description
Manufacturer symbol ISO 15223-1 5.1.1 Manufacturer
Indicates the medical device manufacturer.
Authorized representative in the European Union symbol ISO 15223-1 5.1.2 Authorized representative in the European Union
Indicates the authorized representative in the European Union.
Date of manufacture symbol ISO 15223-1 5.1.3 Date of manufacture
Indicates the date when the medical device was manufactured.
Use by expiration date symbol ISO 15223-1 5.1.4 Use by (expiration date)
Indicates the date after which the medical device is not to be used.
Batch code symbol ISO 15223-1 5.1.5 Batch code
Indicates the manufacturer's batch code so that the batch or lot can be identified.
Catalog number or Reference number symbol ISO 15223-1 5.1.6 Catalog number / Reference number
Indicates the manufacturer's catalog number so that the medical device can be identified.
Serial number symbol ISO 15223-1 5.1.7 Serial number
Indicates the manufacturer's serial number so that a specific medical device can be identified.
Importer symbol ISO 15223-1 5.1.8 Importer
Indicates the entity importing the medical device into the European Union.
Distributor symbol ISO 15223-1 5.1.9 Distributor
Indicates the entity distributing the medical device into the locale.
Fragile handle with care symbol ISO 15223-1 5.3.1 Fragile: handle with care
Indicates a medical device that can be broken or damaged if not handled carefully.
Keep away from rain symbol ISO 15223-1 5.3.4 Keep away from rain
Indicates that the transport package should be stored and transported in dry conditions, protected from rain.
Temperature limit symbol ISO 15223-1 5.3.7 Temperature limit
Indicates the temperature limits to which the medical device can be safely exposed.
Do not re-use symbol ISO 15223-1 5.4.2 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.
Consult instructions for use symbol ISO 15223-1 5.4.3 Consult instructions for use
Indicates the need for the user to consult the instructions for use.
Caution symbol ISO 15223-1 5.4.4 Caution
Indicates the need for the user to consult the instructions for use for important cautionary information, such as warnings and precautions, that cannot be presented on the medical device itself.
In Vitro Diagnostic medical device symbol ISO 15223-1 5.5.1 In vitro diagnostic medical device
Indicates a medical device that is intended to be used as an in vitro diagnostic medical device.

ISO 7000

Graphical symbols for use on equipment—Registered symbols.

Symbol Standard/Regulation Reference Description
Recycle symbol ISO 7000 1135 Recycle
Indicates that the marked item or its material is part of a recovery or recycling process.
Technical manual symbol ISO 7000 1640 Technical manual: manual for service
Identifies the location where the handbook is stored or identifies information related to the servicing instructions for the equipment. It also indicates that the service manual or handbook should be considered when servicing the device.
Ventilation open symbol ISO 7000 2594 Ventilation open
Identifies the control that allows outside air into the interior environment.
USB symbol ISO 7000 3650 USB
Identifies a port or plug as meeting the generic requirements of the Universal Serial Bus (USB). It may also indicate that the device is plugged into or is compatible with a USB port.

IEC 60417

Graphical symbols for use on equipment.

Symbol Standard/Regulation Reference Description
On symbol IEC 60417 5007 On
Indicates connection to the mains, at least for mains switches or their positions, and all cases where safety is involved.
Off symbol IEC 60417 5008 Off
Indicates disconnection from the mains, at least for mains switches or their positions, and all cases where safety is involved.
Stand-by symbol IEC 60417 5009 Stand-by
Identifies the switch or switch position by which part of the equipment is switched on to bring it into the standby condition.
Fuse symbol IEC 60417 5016 Fuse
Identifies fuse boxes or their location.
Protective earth symbol IEC 60417 5019 Protective earth: protective ground
A terminal intended for connection to an external conductor for protection against electric shock in case of a fault, or the terminal of a protective earth (ground) electrode.
Single phase alternating current symbol IEC 60417 5032 Single phase alternating current
Indicates on the rating plate that the equipment is suitable for alternating current only and identifies relevant terminals.
Electrostatic Sensitive Devices symbol IEC 60417 5134 Electrostatic Sensitive Devices
Identifies packages containing electrostatic sensitive devices, or a device or connector that has not been tested for immunity to electrostatic discharge.
Computer network symbol IEC 60417 5988 Computer network
Identifies the computer network itself or indicates the connecting terminals of the computer network.
Warning ultraviolet radiation symbol IEC 60417 6040 Warning: Ultraviolet radiation
Alerts the user to the presence of UV light within the product enclosure that may be sufficient to constitute a risk to the operator. Turn off the UV lamp before opening. Use UV radiation eye and skin protection during servicing.
Caution moving parts symbol IEC 60417 6057 Caution: moving parts
An instructional safeguard to keep away from moving parts.
Information general symbol IEC 60417 6222 Information: general
Identifies the control used to examine the status of the equipment, such as multifunctional copying machines.

Other Symbols and Markings

Symbol Standard/Regulation Reference Description
Prescription only symbol 21 CFR 801.15(c)(1)(i)(F) N/A Prescription only
Recognized by the US FDA as an alternate to “Caution: Federal law restricts this device to sale by or on the order of a licensed practitioner.”
European Conformity symbol N/A N/A European Conformity
The instrument Declaration of Conformity lists the Directives with which the system complies.
WEEE Directive symbol Directive 2012/19/EC N/A Waste Electrical and Electronic Equipment (WEEE) Directive
The electronic product should not be discarded as unsorted waste but must be sent to separate collection facilities for recovery and recycling. The device was placed on the European Market after August 13, 2005, and must not be disposed of through the municipal waste collection system.
Regulatory Compliance Mark symbol AS/NZS 4417.1 N/A Regulatory Compliance Mark (RCM)
Indicates compliance with the Australian Communications Media Authority (ACMA) requirements for safety and EMC in Australia and New Zealand.
RoHS 2 symbol People’s Republic of China Electronic Industry Standard SJ/T11364 N/A Restriction of Hazardous Substances (RoHS 2)
Indicates that this electronic information product contains certain toxic or hazardous elements and can be used safely during its environmental protection use period. The number in the middle of the logo indicates the environmental protection use period in years.
RoHS 2 environmentally friendly symbol People’s Republic of China Electronic Industry Standard SJ/T11364 N/A Restriction of Hazardous Substances (RoHS 2)
Indicates that this electronic information product does not contain hazardous substances, or that they do not exceed the concentration limits specified in GB/T 26572. It is an environmentally friendly product that can be recycled.
FCC symbol Title 47 United States Code of Federal Regulations Part 15 N/A Federal Communications Commission (FCC)
This product has been tested and found to comply with the limits pursuant to Part 15 of the FCC Rules.
UL certification mark N/A N/A Underwriters Laboratory (UL) certification mark
Underwriters Laboratories have certified that the listed products comply with both US and Canadian safety requirements.
CSA Group symbol CSA International N/A Listed device with CSA Group testing agency
CSA Group has certified that the listed products comply with both US and Canadian safety requirements.
Intertek testing agency symbol N/A N/A Listed device with Intertek testing agency
Intertek Testing Agency has certified that the listed products comply with both US and Canadian safety requirements.
Swiss Authorised Representative symbol Ordinance on In Vitro Diagnostic Medical Devices (IvDO) of 4 May 2022 N/A Swiss Authorised Representative
Indicates the Swiss Authorised representative.
Relative humidity range symbol N/A N/A Relative humidity range
Indicates the acceptable upper and lower limits of relative humidity for transport and storage. This symbol is accompanied by the applicable relative humidity limits.
Unconnected port symbol N/A N/A Unconnected port
This product has an unconnected port on the syringe pump.

Safety Symbols

Explanation of the safety symbols used for BOND instruments.

ISO 7010

Graphical symbols—Safety colors and safety signs—Registered safety signs.

Symbol Standard/Regulation Reference Description
General warning symbol ISO 7010 W001 General warning
Indicates the need for the user to consult the instructions for use for important cautionary information, such as warnings and precautions, that cannot be presented on the medical device itself.
Warning laser beam symbol ISO 7010 W004 Warning: laser beam
Laser hazard. Potential for severe eye damage. Avoid direct eye contact with laser beams.
Warning biological hazard symbol ISO 7010 W009 Warning: biological hazard
Biological hazard. Potential exposure to a biological hazard. Follow directions in the accompanying documentation to avoid exposure.
Risk of electric shock symbol ISO 7010 W012 Caution: risk of electric shock
Electrical hazard. Potential risk of electric shock. Follow directions in the accompanying documentation to avoid damage to persons or equipment.
Warning toxic material symbol ISO 7010 W016 Warning: toxic material
Toxic hazard. Potential danger of severe health impacts if proper chemical handling procedures are not followed. Use gloves and protective eye wear when handling reagents.
Warning hot surface symbol ISO 7010 W017 Warning: hot surface
Heat hazard. Hot surfaces will cause burns if touched. Avoid touching parts identified with this symbol.
Warning overhead obstacle symbol ISO 7010 W020 Warning: Overhead obstacle
Overhead obstacle. Take care to avoid being struck by or walking into an overhead obstacle.
Warning flammable material symbol ISO 7010 W021 Warning: flammable material
Flammable hazard. Flammable materials may ignite if proper precautions are not followed.
Warning sharp element symbol ISO 7010 W022 Warning: Sharp element
Sharp element. Take care to avoid injury from sharp elements, such as needles or blades.
Warning corrosive substance symbol ISO 7010 W023 Warning: corrosive substance
Chemical hazard from a corrosive substance. There is a danger of severe health impacts if proper precautions are not followed. Always wear protective clothing and gloves. Immediately clean up spills using standard laboratory practice.
Warning crushing of hands symbol ISO 7010 W024 Warning: crushing of hands
Crush hazard. Hands or body parts can be crushed by a closing motion of mechanical parts of equipment.
Warning environmental hazard symbol ISO 7010 W072 Warning: Environmental hazard
Environmental hazard. Substance or mixture that can cause an environmental hazard.