Symbols Glossary

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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”.

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

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)

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

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

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

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

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

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

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

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)

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)

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)

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

ISO 7000
Reference no. 2794

Graphical symbols for use on equipment.

Packaging unit

To indicate the number of pieces in the package

ISO 7000
Reference no. 0623

Graphical symbols for use on equipment - registered symbols

This way up

N/A

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

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.

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.

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

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

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

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.

N/A

N/A

Do not freeze

Indicates the medical device should not be frozen

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

N/A

N/A

USA

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

ISO 7001

Public Information Symbol

Recycling

To indicate the location of a recycling bin or container.