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 an FDA recognised Standards Development Organization.

Symbol Title Origin Description Notes
Catalogue Number ISO7000: 2014-2493 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: 2014-2492 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: 2014-2498 Indicates the manufacturer's serial number so that a specific medical device can be identified. NA
Manufacturer ISO7000: 2014-3082 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: 2014-2497 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: 2014-0632 Indicates the temperature limits to which the medical device can be safely exposed. The upper and lower limits of temperature are indicated adjacent to the upper and lower horizontal lines
Humidity Limitation ISO7000: 2014-2620 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: 2014-2621 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 Clause 5.1.2 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 ISO7000: 2014-2725 & ISO7000: 2014-6287 Not made with natural rubber latex Consists of the ISO symbol “Contains or presence of natural rubber latex” with the ISO negation symbol to indicate "Not Made with Natural Rubber Latex"
Contains Latex ISO7000: 2014-2725 Contains or presence of natural rubber latex.  
Contains Phthalates ISO7000: 2014-2725 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: 2014-1015 Indicates a medical device that is intended for one use, or for use on a single patient during a single procedure.  Synonyms for "Do not re-use" are "single use" and "use only once".
Caution ISO7000: 2014-0434B 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. The symbol variant ISO 7000-0434B (“Caution”) may also be used.
Consult Instructions For Use ISO7000: 2014-1641 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: 2014-2606 Indicates a medical device that should not be used if the package has been damaged or opened. NA
Use-By Date ISO7000: 2014-2607 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: 2014-0624 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 Dry ISO7000: 2014-2626 Indicates a medical device that needs to be protected from moisture. NA
Fragile, Handle with Care ISO7000: 2014-0621 Indicates a medical device that can be broken or damaged if not handled carefully. NA
WEEE EN 2012/19/EU EN 50419 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.   
This Way Up ISO7000: 2014-0623 To indicate correct upright position of the transport package. NA
General symbol for recovery/ recyclable ISO7000: 2014-1135 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.   
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.  
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.   

References

  • 01

    DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration 21 CFR Parts 660, 801, and 809, FDA–2013–N–0125, RIN 0910–AG74, Use of Symbols in Labelling, 13 September 2016.

  • 02

    ISO 15223-1:2012 Medical Devices - Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General Requirements.

  • 03

    ISO 7000:2014(E/F) Graphical symbols for use on equipment — Index and synopsis.

  • 04

    ISO 7010:2011 — Graphical symbols -- Safety colours and safety signs -- Registered safety signs.

  • 05

    IEC 60417:2002 DB Graphical symbols for use on equipment.

  • 06

    IEC 60529:1989+AMD1:1999+AMD2:2013 CSV Consolidated version, Degrees of protection provided by enclosures (IP Code).

  • 07

    EN 50419 Marking of electrical and electronic equipment in accordance with Article 11(2) of Directive 2002/96/EC (WEEE), 2005.

  • 08

    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.

  • 09

    ASTM F2503-13, Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment, ASTM International, West Conshohocken, PA, 2013, www.astm.org.

  • 10

    IATA Packing Instruction 965 Section IB, International Air Transport Association (IATA) 2017.