Symbols Glossary

An explanation of the symbols used in the product labelling of ResMed medical devices.

The following symbols do not require English text adjacent to the symbol as these are sourced from a Standards Development Organization established symbol

Title	Origin	Description	Notes
Catalogue Number	ISO7000: 2019-2493	Indicates the manufacturer’s catalogue number so that the medical device can be identified.	Synonyms for “catalogue number” are “reference number” and “reorder number”.
Batch Code	ISO7000: 2019-2492	Indicates the manufacturer’s batch code so that the batch or lot can be identified.	This symbol shall be accompanied by the manufacturer’s batch code. Synonyms for “batch code” are “lot number” and “batch number”.
Serial Number	ISO7000: 2019-2498	Indicates the manufacturer’s serial number so that a specific medical device can be identified.	NA
Manufacturer	ISO7000: 2019-3082	Indicates the medical device manufacturer, as defined in EU Directives 90/385/EEC, 93/42/EEC and 98/79/EC.	This symbol shall be accompanied by the name and address of the manufacturer. The date of manufacture, as well as the name and address of the manufacturer, can be combined in one symbol.
Date of Manufacture	ISO7000: 2019-2497	Indicates the date when the medical device was manufactured.	This symbol shall be accompanied by a date to indicate the date of manufacture, expressed as in ISO 8601 as four digits for the year and, two digits for the month and two digits for the day. This symbol can be filled or unfilled. If filled, the date of manufacture as well as the name and address of the manufacture can be combined in one symbol
Temperature Limit	ISO7000: 2019-0632	Indicates the temperature limits to which the medical device can be safely exposed.	The upper and lower limits of temperature is indicated adjacent to the upper and lower horizontal lines
Humidity Limitation	ISO7000: 2019-2620	Indicates the range of humidity to which the medical device can be safely exposed.	The upper and lower limits of humidity are indicated adjacent to the upper and lower horizontal lines.
Atmospeheric Pressure Limitation	ISO7000: 2019-2621	Indicates the range of atmospheric pressure to which the medical device can be safely exposed.	The upper and lower limits of atmospheric pressure are indicated adjacent to the upper and lower horizontal lines.
European Community Representative	ISO15223: 2016	Indicates the Authorized representative in the European Community.	This symbol shall be accompanied by the name and address of the authorized representative in the European Community.
Latex Free	ISO 7000:2019-2725	Not made with natural rubber latex	Consists of the ISO symbol “Contains or presence of natural rubber latex” with the negation symbol from IEC 80416-3 to indicate “Not Made with Natural Rubber Latex”
Contains Latex	ISO7000: 2019-2725	Contains or presence of natural rubber latex.	NA
Contains Phthalates	ISO7000: 2019-2725	Contains or presence of phthalates.	May include one or more additional texts identifying specific phthalates or sub-groups of phthalates, BBP, DBP
Do Not Re-use	ISO7000: 2004-1051	Indicates a medical device that is intended for one single use only.	Synonyms for “Do not re-use” are “single use” and “use only once”.
Caution	ISO7000: 2004-0434A	Indicates that caution is necessary when operating the device or control close to where the symbol is placed, or that the current situation needs operator awareness or operator action in order to avoid undesirable consequences.	The symbol variant ISO 7000-0434B (“Caution”) may be used.
Consult Instructions For Use	ISO7000: 2019-1641	Indicates the need for the user to consult the instructions for use.	Synonym for “Consult instructions for use” is “Consult operating instructions”.
Do Not Use if Package is Damaged	ISO7000: 2019-2606	Indicates a medical device that should not be used if the package has been damaged or opened.	NA
Use-By Date	ISO7000: 2019-2497	Indicates the date after which the medical device is not to be used.	This symbol shall be accompanied by a date to indicate that the medical device should not be used after the end of the date shown. The date shall be expressed as in ISO 8601 as four digits for the year and, where appropriate, two digits for the month and two digits for the day.
Keep Away From Sunlight	ISO7000: 2019-0624	Indicates a medical device that needs protection from light sources.	This symbol can also mean “Keep away from heat”, as referenced in ISO 7000:1989.
Keep Away From Rain	ISO7000: 2019-0626	Indicates a medical device that needs to be protected from moisture.	This symbol can also mean “Keep dry” as referenced in ISO 15223-1:2016.
Fragile, Handle with Care	ISO7000: 2019-0621	Indicates a medical device that can be broken or damaged if not handled carefully.	NA
WEEE	EU Directive 2012/19/EU	Waste in Electrical and Electronic Equipment.	The Directive provides for the creation of collection schemes where consumers return their WEEE free of charge.
WEEE Separate Collection	EU Directive 2006/66/EC	The symbol indicating ‘separate collection’ for all batteries and accumulators.	NA
This Way Up	ISO7000: 2019-0623	To indicate correct upright position of the transport package.	NA
General symbol for recovery/recyclable	ISO7000: 2019-1135	To indicate that a material is part of a recovery or recycling process.	NA
Non-ionizing electromagnetic radiation	IEC60417:2002-5140	Indicates equipment or systems e.g. medical devices, that include RF transmitters or that intentionally apply RF electromagnetic energy for diagnosis or treatment.	Also indicates generally elevated, potentially hazardous, levels of nonionizing radiation.
Type B applied part	IEC60417: 2002-5840	On medical equipment to identify a type B applied part complying with IEC 60601-1	B = Body. Used for applied parts that are generally not conductive and can be immediately released from the patient. May be connected to earth.
Type BF Applied Part	IEC60417: 2002-5333	To identify a type BF applied part complying with IEC 60601-1.	BF = Body Floating, Used for devices that have conductive contact with the patient, or having medium or long term contact with the patient. May not be connected to earth (floating).
Type CF Applied Part	IEC60417: 2002-5335	To identify a type CF applied part complying with IEC 60601-1.	Type CF, Cardial Floating, is the most stringent classification, being required for those applications where the applied part is in direct conductive contact with the heart or other applications as considered necessary.
Refer to instruction manual/booklet	ISO7010-M002	To signify that the instruction manual/booklet must be read.	NA
Stand-by	IEC60417: 2002-5009	Indicates a sleep mode or low power state.	The switch does not fully disconnect the device from its power supply.
Direct current	IEC60417: 2002-5031	To indicate on the rating plate that the equipment is suitable for direct current only; to identify relevant terminals.	NA
Alternating current	IEC60417: 2002-5032	To indicate on the rating plate that the equipment is suitable for alternating current only; to identify relevant terminals.	NA
Class II Equipment	IEC60417: 2002-5172	To identify equipment meeting the safety requirements specified for Class II equipment according to IEC 61140	A Class II or double insulated electrical appliance is one which has been designed in such a way that it does not require a safety connection to electrical earth (ground).
Fuse	IEC60417: 2002-5016	To identify fuse boxes or their location.	NA
Battery Check	IEC60417: 2002-5546	To identify a control to check the condition of a primary or secondary battery or to identify the battery condition indicator.	NA
MR Unsafe	ASTM F2503-13	An item that is known to pose hazards in all MRI environments.	NA
USA Regulatory Mark	21 CFR 801	Replaces “Caution: Federal law restricts this device to sale by or on the order of a physician.”	An alternative to the text “Rx Only”
IP Rating	IEC60529: 2001	Classifies and rates the degree of protection provided against intrusion (body parts such as hands and fingers), dust, accidental contact, and water by mechanical casings and electrical enclosures.	Numbers indicate the degree of protection.
Class 9 – Miscellaneous Dangerous Goods	IATA Packing Instruction 965 Section IB	Applies to lithium ion cells with a Watt-hour rating not exceeding 20 Wh and lithium ion batteries with a Watt-hour rating not exceeding 100 Wh packed in quantities that exceed the allowance permitted in the standard.	NA
Indoor Use Only	IEC60417-2004-5957	To identify electrical equipment designed primarily for indoor use.	NA
Alarm Inhibit	ISO60417: 2002-5319	Indicates that the pulse oximeter monitor is not provided with a low SpO₂ alarm condition.	NA
Keep out of reach of children	IEC60417:2002-6091	Indicates devices and equipment that shall be kept out of reach of children.	NA
Bell, cancel temporary	IEC60417:2002-5576-2	On medical ALARM SYSTEMS this graphical symbol is used as follows: To indicate that an ALARM CONDITION is in the ACKNOWLEDGED state until a time interval has elapsed.	NA
ON/OFF	IEC60417:2002-5010	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.Each position, “ON” or “OFF”, is a stable position.	NA
Universal Serial Bus (USB), Port/Plug	ISO7000:2019-3650	To identify a port or plug as meeting the generic requirements of the Universal Serial Bus (USB). To indicate that the device is plugged into a USB port or is compatible with a USB port.	This graphical symbol is based on the USB symbol standardized by USB Implementers Forum.
Bell	IEC60417:2002-5013	To identify switches which operate bells	To indicate an alarm system connection on a medical alarm system
Alarm, general	IEC60417:2002-5307	To indicate an alarm on a control equipment.	NA
Importer	ISO7000: 2019-3725	Indicates the entity importing the medical device into the locale.	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.
Contains hazardous substances	ISO 7000: 2019-3723	Indicates a medical device that contains substances that can be carcinogenic, mutagenic, reprotoxic (CMR), or substances with endocrine disrupting properties.	The term “substances” is used to indicate a single substance or multiple substances.
Single patient multiple use	ISO 7000: 2019-3706	Indicates a medical device that may be used multiple times (multiple procedures) on a single patient.	NA
Medical Device	N/A	Indicates the item is a medical device.	For use in Europe the full definition of “medical device” is given in EU Regulation 2017/745.
Unique device identifier	N/A	Indicates a carrier that contains unique device identifier information.	This symbol identifies the UDI carrier, including the AIDC and human readable information.

References

ISO 7000:2019 Graphical symbols for use on equipment – Index and synopsis.
ISO 15223-1:2016 Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Par 1: General requirements.
Directive 2012/19/EU of the European Parliament and of the Council of 4 July 2012 on waste electrical and electronic equipment (WEEE), Official Journal of the European Union.
Directive 2006/66/EC of the European Parliament and of the Council of the 6 September 2006 on batteries and accumulators and repealing Directive 91/157/EEC”, Official Journal of the European Union.
IEC 60417:2002 Graphical symbols for use on equipment.
ISO 7010:2019 Graphical symbols – Safety colours and safety signs — Registered safety signs.
ASTM F2503-13, Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment.
Food and Drug Administration, 21 CFR Part 801 – Labelling.
IEC 60529:1989/AMD1:1999+AMD2:2013 Degrees of protection provided by enclosures (IP Code).
IATA Packing Instruction 965 Section IB, International Air Transport Association (IATA).
ISO 15223-1:2021 – Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements.
(EU) 2017/745, Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices. OJ L 117, Official Journal of the European Union.