Glossary of Symbols

Symbol image Traceability Title Description
Manufacturer ISO 15223-1, Medical Devices – Symbols to be used with information to be supplied by the manufacturer - Part 1 General Requirements: Clause 5.1.1
ISO 7000: Graphical symbols for use on equipment: 3082 		Manufacturer Indicates the medical device manufacturer
Date of manufacture ISO 15223-1, Medical Devices – Symbols to be used with information to be supplied by the manufacturer - Part 1 General Requirements: Clause 5.1.3
ISO 7000: Graphical symbols for use on equipment: 2497		 Date of manufacture Indicates the date when the medical device was manufactured.
Model Number ISO 15223-1, Medical Devices – Symbols to be used with information to be supplied by the manufacturer - Part 1 General Requirements: Clause 5.1.10 Model Number Indicates the model number or type number of a product.
Catalogue number ISO 15223-1, Medical Devices – Symbols to be used with information to be supplied by the manufacturer - Part 1 General Requirements: Clause 5.1.6
ISO 7000: Graphical symbols for use on equipment: 2493		 Catalogue number Indicates the manufacturer's catalog number so that the medical device can be identified.
Serial number ISO 15223-1, Medical Devices – Symbols to be used with information to be supplied by the manufacturer - Part 1 General Requirements: Clause 5.1.7
ISO 7000: Graphical symbols for use on equipment: 2498		 Serial number Indicates the manufacturer's serial number so that a specific medical device can be identified.
Unique Device Identifier ISO 15223-1, Medical Devices – Symbols to be used with information to be supplied by the manufacturer - Part 1 General Requirements: Clause 5.7.10 Unique Device Identifier Indicates a carrier that contains unique device identifier information.
Batch code ISO 15223-1, Medical Devices – Symbols to be used with information to be supplied by the manufacturer - Part 1 General Requirements: Clause 5.1.5
ISO 7000: Graphical symbols for use on equipment: 2492		 Batch code Indicates the manufacturer's batch code so that the batch or lot can be identified.
Use by date ISO 15223-1, Medical Devices – Symbols to be used with information to be supplied by the manufacturer - Part 1 General Requirements: Clause 5.1.4
ISO 7000: Graphical symbols for use on equipment: 2607		 Use by date Indicates the date after which the medical device is not to be used.
Medical device ISO 15223-1, Medical Devices – Symbols to be used with information to be supplied by the manufacturer - Part 1 General Requirements: Clause 5.7.7
MDR 2017/745		 Medical device Indicates the item is a medical device
ECREP ISO 15223-1, Medical Devices – Symbols to be used with information to be supplied by the manufacturer - Part 1 General Requirements: Clause 5.1.2 Authorised representative in the European Community/European Union Indicates the Authorized Representative in the European Community/European Union
CHREP ISO 20417: Medical devices — Information to be supplied by the manufacturer
Ref no. 6.1.2		 Authorised representative in Switzerland Indicates the Authorised Representative in Switzerland
Consult instructions for use ISO 15223-1, Medical Devices – Symbols to be used with information to be supplied by the manufacturer - Part 1 General Requirements: Clause 5.4.3
ISO 7000: Graphical symbols for use on equipment: 1641		 Consult instructions for use Indicates the need for the user to consult the instructions for use
Booklet ISO 7010: Graphical symbols - safety colours and safety signs - registered safety signs: M002
FDA recognition # 5-116
IEC 60601-1, Annex D, Table D.2, No. 10		 Refer to instruction manual/booklet Signifies that the instruction manual/booklet must be read
Caution ISO 15223-1, Medical Devices – Symbols to be used with information to be supplied by the manufacturer - Part 1 General Requirements: Clause 5.4.4
ISO 7000: Graphical symbols for use on equipment: 0434A		 Caution 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
General warning sign ISO 7010: Graphical symbols - safety colours and safety signs - registered safety signs: W001
FDA recognition # 5-116		 General warning sign Indicates a general warning
Package Damaged ISO 15223-1, Medical Devices – Symbols to be used with information to be supplied by the manufacturer - Part 1 General Requirements: Clause 5.2.8
ISO 7000: Graphical symbols for use on equipment: 2606		 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
Fragile ISO 15223-1, Medical Devices – Symbols to be used with information to be supplied by the manufacturer - Part 1 General Requirements: Clause 5.3.1
ISO 7000: Graphical symbols for use on equipment: 621		 Fragile, handle with care Indicates a medical device that can be broken or damaged if not handled carefully
Keep dry ISO 15223-1, Medical Devices – Symbols to be used with information to be supplied by the manufacturer - Part 1 General Requirements: Clause 5.3.4
ISO 7000: Graphical symbols for use on equipment: 626		 Keep dry Indicates a medical device that needs to be protected from moisture
Temperature limit ISO 15223-1, Medical Devices – Symbols to be used with information to be supplied by the manufacturer - Part 1 General Requirements: Clause 5.3.7
ISO 7000: Graphical symbols for use on equipment: 632		 Temperature limit Indicates the temperature limits to which the medical device can be safely exposed
Lower limit of temperature ISO 15223-1, Medical Devices – Symbols to be used with information to be supplied by the manufacturer - Part 1 General Requirements: Clause 5.3.5
ISO 7000: Graphical symbols for use on equipment: 534		 Lower limit of temperature Indicates the lower limit of temperature to which the medical device can be safely exposed
Upper limit of temperature ISO 15223-1, Medical Devices – Symbols to be used with information to be supplied by the manufacturer - Part 1 General Requirements: Clause 5.3.6
ISO 7000: Graphical symbols for use on equipment: 533		 Upper limit of temperature Indicates the upper limit of temperature to which the medical device can be safely exposed
Humidity limitation ISO 15223-1, Medical Devices – Symbols to be used with information to be supplied by the manufacturer - Part 1 General Requirements: Clause 5.3.8
ISO 7000: Graphical symbols for use on equipment: 2620		 Humidity limitation Indicates the range of humidity to which the medical device can be safely exposed.
WEEE Bar Article 11(2) of Directive 2002/96/EC on waste electrical and electronic equipment (WEEE) WEEE Indicates separate collection for electrical and electronic equipment and that the product was manufactured after 2005
WEEE Article 11(2) of Directive 2002/96/EC on waste electrical and electronic equipment (WEEE) WEEE Indicates separate collection for electrical and electronic equipment
Recyclable ISO 7001: Public information symbol: 1135 Recyclable To indicate that the marked item or its material is part of a recovery or recycling process
Type B applied part ISO 7000: Graphical symbols for use on equipment: 5840
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 To identify a type B applied part complying with, IEC 60601-1
Type BF part ISO 7000: Graphical symbols for use on equipment: 5333
60601-1, Table D.1, Symbol 20: Medical electrical equipment — Part 1: General requirements. for basic safety and essential performance
FDA recognition # 5-102		 Type BF part To identify a type BF applied part complying with, IEC 60601-1
Class II equipment ISO 7000: Graphical symbols for use on equipment: 5172 Class II equipment Identifies equipment meeting the safety requirements specified for Class II equipment according to IEC 61140
Sterilized by EO ISO 15223-1, Medical Devices – Symbols to be used with information to be supplied by the manufacturer - Part 1 General Requirements: Clause 5.2.3
ISO 7000: Graphical symbols for use on equipment: 2501		 Sterilized by ethylene oxide Indicates a medical device that has been sterilized using ethylene oxide
Sterilized R ISO 15223-1, Medical Devices – Symbols to be used with information to be supplied by the manufacturer - Part 1 General Requirements: Clause 5.2.4
ISO 7000: Graphical symbols for use on equipment: 2502		 Sterilized Using Irradiation Indicates a medical device that has been sterilized using irradiation
Single sterile barrier system ISO 15223-1, Medical Devices – Symbols to be used with information to be supplied by the manufacturer - Part 1 General Requirements: Clause 5.2.11
ISO 7000: Graphical symbols for use on equipment: 3707		 Single sterile barrier system Indicates a single sterile barrier system
Single sterile barrier system with PPI ISO 15223-1, Medical Devices – Symbols to be used with information to be supplied by the manufacturer - Part 1 General Requirements: Clause 5.2.13
ISO 7000: Graphical symbols for use on equipment: 3708		 Single sterile barrier system with protective packaging inside Indicates a single sterile barrier system with protective packaging inside
Single sterile barrier system with PPO ISO 15223-1, Medical Devices – Symbols to be used with information to be supplied by the manufacturer - Part 1 General Requirements: Clause 5.2.14
ISO 7000: Graphical symbols for use on equipment: 3709		 Single sterile barrier system with protective packaging outside Indicates a single sterile barrier system with protective packaging outside
Non-sterile ISO 15223-1, Medical Devices – Symbols to be used with information to be supplied by the manufacturer - Part 1 General Requirements: Clause 5.2.7
ISO 7000: Graphical symbols for use on equipment: 2609		 Non-sterile Indicates a medical device that has not been subjected to a sterilization process
Do not resterilise ISO 15223-1, Medical Devices – Symbols to be used with information to be supplied by the manufacturer - Part 1 General Requirements: Clause 5.2.6
ISO 7000: Graphical symbols for use on equipment: 2608		 Do not resterilise Indicates a medical device that is not to be resterilised
Do not re-use ISO 15223-1, Medical Devices – Symbols to be used with information to be supplied by the manufacturer - Part 1 General Requirements: Clause 5.4.2
ISO 7000: Graphical symbols for use on equipment: 1051		 Do not re-use Indicates a medical device that is intended for single use only
MR safe ASTM F2503: Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
Reference no. Table 3; 7.4.4.1; Fig 4		 MR safe Indicates that the product is safe to be used with an MRI
MR conditional Yellow ASTM F2503: Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
Reference no. Table 2; 7.4.6.1; Fig 6,7		 MR conditional Indicates that the product is safe to be used with an MRI under certain specific conditions
MR conditional ASTM F2503: Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
Reference no. Table 2; 7.4.6.1; Fig 6,7		 MR conditional Indicates that the product is safe to be used with an MRI under certain specific conditions
MR unsafe ASTM F2503: Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
Reference no. Table 2, Symbol 7.3.3; 7.4.9.1; Fig. 9		 MR unsafe Indicates that the product must be removed before undergoing an MRI
natural rubber latex ISO 15223-1, Medical Devices – Symbols to be used with information to be supplied by the manufacturer - Part 1 General Requirements: Clause 5.4.5
ISO 7000: Graphical symbols for use on equipment: 2725		 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
medicinal substance ISO 15223-1, Medical Devices – Symbols to be used with information to be supplied by the manufacturer - Part 1 General Requirements: Clause 5.4.7
ISO 7000: Graphical symbols for use on equipment: 3702		 Contains a medicinal substance Indicates a medical device that contains or incorporates a medicinal substance
hazardous substances ISO 15223-1, Medical Devices – Symbols to be used with information to be supplied by the manufacturer - Part 1 General Requirements: Clause 5.4.10
ISO 7000: Graphical symbols for use on equipment: 3723		 Contains hazardous substances Indicates a medical device that contains substances that can be carcinogenic, mutagenic, reprotoxic (CMR), or substances with endocrine-disrupting properties
Patient identification ISO 15223-1, Medical Devices – Symbols to be used with information to be supplied by the manufacturer - Part 1 General Requirements: Clause 5.7.3
ISO 7000: Graphical symbols for use on equipment: 5664		 Patient identification Indicates the identification data of the patient
Patient information website ISO 15223-1, Medical Devices – Symbols to be used with information to be supplied by the manufacturer - Part 1 General Requirements: Clause 5.7.4
ISO 7000: Graphical symbols for use on equipment: 3705		 Patient information website Indicates a website where a patient can obtain additional information on the medical product
Doctor ISO 15223-1, Medical Devices – Symbols to be used with information to be supplied by the manufacturer - Part 1 General Requirements: Clause 5.7.5
ISO 7001: Public information symbol: PI FF 044		 Health care center or doctor Indicates the address of the healthcare center or doctor where medical information about the patient may be found
Date ISO 15223-1, Medical Devices – Symbols to be used with information to be supplied by the manufacturer - Part 1 General Requirements: Clause 5.7.6
ISO 7000: Graphical symbols for use on equipment: 5662		 Date Indicates the date that information was entered or a medical procedure took place
Rx Only 21 CFR 801.15(c)(1)(i)F
21 CFR 801.109		 RX Only By prescription
Caution: US law restricts this device to sale by, or on the order of, a physician
CE 765/2008/EC
768/2008/EC MDD
93/42/EEC Articles 4,11,12,17, Annex II)
Regulation (EU) 2017/745		 CE CE registration mark
CE0123 NA CE0123 A CE marking followed by a four-digit identification number indicates that a Notified Body (NB) was involved in conformity assessment.
CE 0123 shows that TÜV SÜD was the Notified Body involved in conformity assessment.
CE2797 NA CE2797 A CE marking followed by a four-digit identification number indicates that a Notified Body (NB) was involved in conformity assessment.
UKCA gov.uk UKCA UK conformity mark
UKCA0086 gov.uk UKCA0086 UK conformity mark with approved body
IP42 IEC 60529 (https://www.iec.ch/ip-ratings)
EN 60529		 IP42 Ingress Protection Rating
  • Protected against ingress of solid foreign objects >1mm diameter
  • Protected against splashing water.
IP54 IEC 60529 (https://www.iec.ch/ip-ratings)
EN 60529		 IP54 Ingress Protection Rating
  • Dust protected
  • Protected against jetting water.
IP67 IEC 60529 (https://www.iec.ch/ip-ratings)
EN 60529		 IP67 Ingress Protection Rating
  • Dust tight
  • Protected against the effects of temporary immersion in water.
IP68 IEC 60529 (https://www.iec.ch/ip-ratings)
EN 60529		 IP68 Ingress Protection Rating
  • Dust tight
  • Protected against the effects of continuous immersion in water.
Bone side NA Bone side Indicates the side of the implant that should face the bone
Skin side NA Skin side Indicates the side of the implant that should face the skin
RCC for ANZ NA Radio compliance certification for Australia and New Zealand Radio compliance certification for Australia and New Zealand
RCC for Japan NA Radio compliance certification for Japan Radio compliance certification for Japan
RCC for Korea NA Radio compliance certification for Korea Radio compliance certification for Korea
RCC for Taiwan NA Radio compliance certification for Taiwan Radio compliance certification for Taiwan
Coil guide NA Coil guide Indicates where to place the coil
Radio interference NA Radio interference Radio interference
Open here ISO 7000: Graphical symbols for use on equipment: 3079 Open here Identifies the location where the package can be opened and to indicate the method of opening it.
eBooklet ISO 7010: Graphical symbols - safety colours and safety signs - registered safety signs: M002
FDA recognition # 5-116
IEC 60601-1, Annex D, Table D.2, No. 10		 Consult electronic instruction manual/booklet Signifies that the electronic instruction manual/booklet must be read
eIFU ISO 15223-1:5.4 Safe use; 5.4.3 Consult electronic instruction for use Consult electronic instruction for use
Compatible sound processors NA Compatible sound processors Compatible sound processors
Compatible implants NA Compatible implants Compatible implants series.