Symbols Glossary

View common symbols, references, titles, and explanations of symbols below. 



SYMBOL

STANDARD REFERENCE

STANDARD TITLE

SYMBOL TITLE

EXPLANATORY TEXT

Manufacturer symbol

ISO 15223- 1:2016
Reference no. 5.1.1. (ISO 7000-3082)

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

Manufacturer

Indicates the medical device manufacturer

Authorized Representative in the European Community symbol

ISO 15223- 1:2016
Reference no. 5.1.2

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

Authorized Representative in the European Community

Indicates the authorized representative in the European Community / European Union

Date of manufacture symbol

ISO 15223- 1:2016
Reference no. 5.1.3. (ISO 7000-2497)

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

Date of manufacture

Indicates the date when the medical device was manufactured

Use-by date symbol

ISO 15223- 1:2016
Reference no. 5.1.4. (ISO 7000-2607)

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

Use-by date
Use by date

Indicates the date after which the medical device is not to be used
iso_15223 Use-by date
iso_grs_7000_2607 Use by date

Batch code symbol

ISO 15223- 1:2016
Reference no. 5.1.5. (ISO 7000-2492)

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

Batch code

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

Catalog number symbol

ISO 15223- 1:2016
Reference no. 5.1.6. (ISO 7000-2493)

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

Catalogue number
Catalog number

Indicates the manufacturer's catalog number so that the medical device can be identified
ISO 15223 Catalogue number
ISO 7000 Catalog number

Serial number symbol

ISO 15223- 1:2016
Reference no. 5.1.7. (ISO 7000-2498)

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

Serial number

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

Country of manufacture symbol

ISO 15223- 1:2020(E) DRAFT
Reference no. 5.1.11. (ISO 7000- 6049)

Medical devices — Symbols to be used with medical device labels, labeling and information to be supplied

Country of manufacture

To identify the country of manufacture of products

Non-sterile symbol

ISO 15223- 1:2016
Reference no. 5.2.7. (ISO 7000-2609)

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

Non-sterile

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

Fragile, handle with care symbol

ISO 15223- 1:2016
Reference no. 5.3.1. (ISO 7000-0621)

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

Fragile, handle with care

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

Keep away from sunlight symbol

ISO 15223- 1:2016
Reference no. 5.3.2. (ISO 7000-0624)

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

Keep away from sunlight

Indicates a medical device that needs protection from light sources

Keep dry symbol

ISO 15223- 1:2016 and ISO 15223-1:2020(E) DRAFT
Reference no. 5.3.4. (ISO 7000-0626)

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

Keep dry
Keep away from rain

Indicates a medical device that needs protection from moisture
ISO 15223 Keep dry
ISO 7000 Keep away from rain

Lower limit of temperature symbol

ISO 15223- 1:2016
Reference no. 5.3.5. (ISO 7000-0534)

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

Lower limit of temperature

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

Upper limit of temperature symbol

ISO 15223- 1:2016
Reference no. 5.3.6. (ISO 7000-0533)

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

Upper limit of temperature

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

Temperature limit symbol

ISO 15223- 1:2016
Reference no. 5.3.7. (ISO 7000-0632)

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

Temperature limit

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

Humidity limitation symbol

ISO 15223- 1:2016
Reference no. 5.3.8. (ISO 7000-2620)

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

Humidity limitation

Indicates the range of humidity t which the medical device can be safely exposed

Atmospheric Pressure limitation symbol

ISO
15223- 1:2016 Reference no. 5.3.9 (ISO 7000-2621)

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

Atmospheric pressure limitation
Atmospheric Pressure limitation

To indicate the acceptable upper and lower limits of atmospheric pressure for transport and storage.
ISO 15223 Atmospheric pressure limitation
ISO 7000 Atmospheric Pressure limitation

Do not use if package is damaged symbol

ISO 15223- 1:2016
Reference no. 5.2.8. (ISO 7000-2606)

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

Do not use if package is damaged

Indicates 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

Do not re-use symbol

ISO 15223-1:2016E
Reference no. 5.4.2. (ISO 7000- 1051)

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

Do not re-use

Indicates a medical device that is intended for one single use only
NOTE: Synonyms for “Do not reuse” are “single use” and “use only once”.

Consult instructions for use symbol

ISO 15223-1:2016 and ISO 15223-1:2020 Reference no. 5.4.3. (ISO 7000-1641)
Reference no. 5.4.3. (ISO 7000-1641)

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

Consult instructions for use
Operator's manual; operating instructions

Indicates the need for the user to consult the instructions for use
iso_15223 Consult instructions for use
iso_grs_7000_1641 Operator's manual; operating instructions

Consult instructions for use or consult symbol

ISO 15223-1:2016
Reference no. A.15

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

Consult instructions for use or consult electronic instructions for use

Indicates consult instructions for
use for an electronic instruction for
use (eIFU)

Caution symbol

ISO 15223- 1:2016 Reference no. 5.4.4. (ISO 7000-0434A)

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

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

General warning sign symbol

iso_grs_7010_WOO1

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

General warning sign

To signify a general warning

Contains or presence of natural rubber latex symbol

ISO 15223- 1:2016
Reference no. 5.4.5. (ISO 7000, symbol 2025)

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

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

Contains hazardous substances symbol

ISO/DIS 15223- 1:2020(E) DRAFT
Reference no. 5.4.10. (ISO 7000-3723)

Medical Devices — Symbols to be used with medical device labels, labeling, and information to be supplied — Part 1: General requirements. (Draft of New Version)

Contains hazardous substances

Indicates a medical device that contains substances that can be carcinogenic, mutagenic, reprotoxic (CMR), or substances with endocrine-disrupting properties

Medical device symbol

ISO/DIS 15223- 1:2020(E) DRAFT
Reference no. 5.7.7

Medical Devices — Symbols to be used with medical device labels, labeling, and information to be supplied — Part 1: General requirements. (Draft of New Version)

Medical device

Indicates the item is a medical device

Translation symbol

ISO 15223-1:2020(E) DRAFT
Reference no. 5.7.8. (ISO 7000-3728)

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

Translation

To identify that the original medical device information has undergone a translation which supplements or replaces the original information

Refer to instruction manual/booklet symbol

EC 60601-1, Reference no. Table D.2, Safety sign 10 (ISO 7010-M002)

Medical electrical equipment — Part 1: General requirements. for basic safety and essential performance

Refer to instruction manual/booklet

To signify that the instruction manual/booklet must be read

Contains or presence of phthalate: benzyl butyl phthalate (BIPingreBP) symbol

BS EN 15986:2011
Reference no. A.4

Symbol for use in the labeling of medical devices — Requirements for labeling of medical devices containing phthalates

Contains or presence of phthalate: benzyl butyl phthalate (BIPingreBP)

Medical device is derived from or manufactured from products containing phthalate: benzyl butyl phthalate (BBP)

Contains or presence of phthalate: bis (2- ethylhexyl) phthalate (DEHP) symbol

BS EN 15986:2011
Reference no. A.4

Symbol for use in the labeling of medical devices — Requirements for labeling of medical devices containing phthalates

Contains or presence of phthalate: bis (2- ethylhexyl) phthalate (DEHP)

Medical device is derived from or manufactured from products containing phthalate: bis (2- ethylhexyl) phthalate (DEHP)

Contains or presence of phthalate: combination of bis symbol

BS EN 15986:2011
Reference no. A.5

Symbol for use in the labeling of medical devices — Requirements for labeling of medical devices containing phthalates

Contains or presence of phthalate: combination of bis (2-ethylhexyl) phthalate (DEHP) and benzyl butyl phthalate (BBP)

Medical device is derived from or manufactured from products containing bis (2-ethylhexyl) phthalate (DEHP) and benzyl butyl phthalate (BBP)

Negation symbol

BS EN 15986
Annex B

Symbol for use in the labeling of medical devices — Requirements for labeling of medical devices containing phthalates.

Negation symbol plus Presence of phthalate symbol, together meaning free of phthalates

Manufacturers wishing to communicate the meaning “does not” or “is not” where a symbol expressing this meaning does not exist, should follow the method set out in EN 80416- 3:2002, Clause 7

Packaging unit

ISO 7000
Reference no. 2794

Graphical symbols for use on equipment.

Packaging unit

To indicate the number of pieces in the package

This way up symbol

ISO 7000
Reference no. 0623

Graphical symbols for use on equipment - registered symbols

This way up

N/A

Do not stack symbol

ISO 7000
Reference no. 2402

Graphical symbols for use on equipment-Registered symbols

Do not stack

To indicate that the item shall not be vertically stacked, either because of the nature of the transport packaging or because of the nature of the items themselves

Magnetic Resonance (MR) safe symbol

ASTM F2503
Reference no. ASTM F2503; Table 2; 7.4.6.1; Fig. 6, 7

Standard practice for Making Medical Devices and other item for safety in the magnetic resonance environment

Magnetic Resonance (MR) safe

3.1.13: An item that poses no known hazards resulting from exposure to any MR environment. MR Safe items are composed of materials that are electrically nonconductive, nonmetallic, and nonmagnetic.

MR Conditional symbol

ASTM F2503
Reference no. Table 2; 7.4.6.1; Fig 6,7

Standard Practice for Marking Medical Devices and Other Items for Safety in the magnetic resonance environment.

MR Conditional

3.3.1.11: an item with demonstrated safety in the MR environment within defined conditions including conditions for the static magnetic field, the time-varying gradient magnetic fields and the radio frequency fields.

(MR) Unsafe symbol

ASTM F2503
Reference no. Table 2, Symbol 7.3.3;
7.4.9.1; Fig. 9

Standard Practice for Marking Medical Devices and other Items for safety in the Magnetic Resonance Environment

(MR) Unsafe

3.1.14: An item which poses unacceptable risks to the patient, medical staff or other persons within the MR environment

CE marking symbol

EU 2017-745 EU 2017-746
Reference no. ANNEX V

REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices, amending Directive 2001/83/ EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/ EEC and 93/42/EEC

CE marking

(43) ‘CE marking of conformity’ or ‘CE marking’ means a marking by which a manufacturer indicates that a device is in conformity with the applicable requirements set out in this Regulation and other applicable Union harmonization legislation providing for its affixing

Highly flammable symbol

GHS
Reference no. 1.4.10.4.2.3 A1.7

Globally Harmonized System of Classification and Labeling of Chemicals (GHS), Eighth Revised Edition

Highly flammable

Medical device contains materials that are highly flammable. Appropriate caution should be taken

Prescription Use Only symbol

N/A

N/A

Prescription Use Only

Caution: Federal law (USA) restricts this device to sale by or on the order of a licensed healthcare practitioner.

Do not freeze symbol

N/A

N/A

Do not freeze

Indicates the medical device should not be frozen

Canadian and US Certification mark symbol

N/A

N/A

Canadian and US Certification mark

Products bearing this mark have been tested and certified in accordance with applicable US and Canadian electrical safety and performance standards

USA manufactured symbol

N/A

N/A

USA

Manufactured in the USA and/or applies to medical devices sold in the USA

Recycling symbol

ISO 7001

Public Information Symbol

Recycling

To indicate the location of a recycling bin or container.

Sterilize2

ISO 15223-1:2021 Reference no. 5.2.6.     (ISO 7000-2608)

Medical devices — Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements.

Do not resterilize

Indicates a medical device that is not to be resterilized.

Sterile EO

ISO 15223-1:2021

Reference no. 5.2.3. (ISO 7000-2501)

Medical devices — Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements.

Sterilized by ethylene oxide treatment

Indicates a medical device that has been sterilized using ethylene oxide.

Sterile R

ISO 15223-1:2021

Reference no. 5.2.4. (ISO 7000-2502)

Medical devices — Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements.

Sterilized using irradiation

Indicates a medical device that has been sterilized using irradiation.

UDI

ISO15223-1: 2021 Reference no. 5.7.10

Medical devices — Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements.

 

Unique device identifier

 

Indicates a carrier that contains unique device identifier information.