Glossary

SYMBOL

STANDARD REFERENCE

ISO 15223-1: 2021
Reference no. 5.1.1. (ISO 7000-3082)

STANDARD TITLE

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

SYMBOL TITLE

Manufacturer

EXPLANATORY TEXT

Indicates the medical device manufacturer

SYMBOL

STANDARD REFERENCE

ISO 15223-1: 2021
Reference no. 5.1.2

STANDARD TITLE

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

SYMBOL TITLE

Authorized Representative in the European Community

EXPLANATORY TEXT

Indicates the authorized representative in the European Community / European Union

SYMBOL

STANDARD REFERENCE

ISO 15223-1: 2021
Reference no. 5.1.3. (ISO 7000-2497)

STANDARD TITLE

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

SYMBOL TITLE

Date of manufacture

EXPLANATORY TEXT

Indicates the date when the medical device was manufactured

SYMBOL

STANDARD REFERENCE

ISO 15223-1: 2021
Reference no. 5.1.4. (ISO 7000-2607)

STANDARD TITLE

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

SYMBOL TITLE

Use by date

EXPLANATORY TEXT

Indicates the date after which the medical device is not to be used

SYMBOL

STANDARD REFERENCE

ISO 15223-1: 2021
Reference no. 5.1.5. (ISO 7000-2492)

STANDARD TITLE

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

SYMBOL TITLE

Batch code

EXPLANATORY TEXT

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

SYMBOL

STANDARD REFERENCE

ISO 15223-1: 2021
Reference no. 5.1.6. (ISO 7000-2493)

STANDARD TITLE

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.

SYMBOL TITLE

Catalogue number

EXPLANATORY TEXT

Indicates the manufacturer’s catalog number

SYMBOL

STANDARD REFERENCE

ISO 15223-1: 2021
Reference no. 5.1.7. (ISO 7000-2498)

STANDARD TITLE

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

SYMBOL TITLE

Serial number

EXPLANATORY TEXT

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

SYMBOL

STANDARD REFERENCE

ISO 15223-1: 2021
Reference no. 5.2.1. (ISO 7000-2499)

STANDARD TITLE

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

SYMBOL TITLE

Sterile

EXPLANATORY TEXT

Indicates a medical device that has been subjected to a sterilization process

SYMBOL

STANDARD REFERENCE

ISO 15223-1:2016
Reference no. 5.2.6.(ISO 7000- 2608)

STANDARD TITLE

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

SYMBOL TITLE

Do not resterilize

EXPLANATORY TEXT

Indicates a medical device that is not to be resterilized

SYMBOL

STANDARD REFERENCE

ISO 15223-1: 2021
Reference no. 5.2.7. (ISO 7000-2609)

STANDARD TITLE

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

SYMBOL TITLE

Non-sterile

EXPLANATORY TEXT

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

SYMBOL

STANDARD REFERENCE

ISO 15223-1: 2021
Reference no. 5.3.2. (ISO 7000-0624)

STANDARD TITLE

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

SYMBOL TITLE

Keep away from sunlight

EXPLANATORY TEXT

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

SYMBOL

STANDARD REFERENCE

ISO 15223-1: 2021
Reference no. 5.3.5. (ISO 7000-0534)

STANDARD TITLE

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

SYMBOL TITLE

Lower limit of temperature

EXPLANATORY TEXT

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

SYMBOL

STANDARD REFERENCE

ISO 15223-1: 2021
Reference no. 5.3.6. (ISO 7000-0533)

STANDARD TITLE

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

SYMBOL TITLE

Upper limit of temperature

EXPLANATORY TEXT

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

SYMBOL

STANDARD REFERENCE

ISO 15223-1: 2021
Reference no. 5.3.7. (ISO 7000-0632)

STANDARD TITLE

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

SYMBOL TITLE

Temperature limit

EXPLANATORY TEXT

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

SYMBOL

STANDARD REFERENCE

ISO 15223-1: 2021
Reference no. 5.3.8. (ISO 7000-2620)

STANDARD TITLE

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

SYMBOL TITLE

Humidity limitation

EXPLANATORY TEXT

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

SYMBOL

STANDARD REFERENCE

ISO 15223-1: 2021
Reference no. 5.2.8. (ISO 7000-2606)

STANDARD TITLE

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

SYMBOL TITLE

Do not use if package is damaged and consult instructions for use

EXPLANATORY TEXT

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

SYMBOL

STANDARD REFERENCE

ISO 15223-1: 2021

STANDARD TITLE

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

SYMBOL TITLE

Biological risks

EXPLANATORY TEXT

To indicate a reference to substances that may be hazardous to men, animals, plants, or the environment based on biological activity (for example, holding a virus)

SYMBOL

STANDARD REFERENCE

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

STANDARD TITLE

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

SYMBOL TITLE

Do not re-use

EXPLANATORY TEXT

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”.

SYMBOL

STANDARD REFERENCE

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)

STANDARD TITLE

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

SYMBOL TITLE

Consult instructions for use or consult electronic instructions for use

EXPLANATORY TEXT

Indicates the need for the user to consult the instructions for use

SYMBOL

STANDARD REFERENCE

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

STANDARD TITLE

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

SYMBOL TITLE

Consult instructions for use or consult electronic instructions for use

EXPLANATORY TEXT

Indicates the need for the user to consult the electronic instructions for use

SYMBOL

STANDARD REFERENCE

ISO 15223-1: 2021 Reference no. 5.4.4. (ISO 7000-0434A)

STANDARD TITLE

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

SYMBOL TITLE

Caution

EXPLANATORY TEXT

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

SYMBOL

STANDARD REFERENCE

ISO 15223-1: 2021
Reference no. 5.4.5. (ISO 7000, symbol 2025)

STANDARD TITLE

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

SYMBOL TITLE

Contains or presence of natural rubber latex

EXPLANATORY TEXT

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

SYMBOL

STANDARD REFERENCE

REGULATION EU 2017/745 & REGULATION EU 2017/746

STANDARD TITLE

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

SYMBOL TITLE

CE marking

EXPLANATORY TEXT

‘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 harmonisation legislation providing for its affixing

SYMBOL

STANDARD REFERENCE

N/A

STANDARD TITLE

N/A

SYMBOL TITLE

Prescription Use Only

EXPLANATORY TEXT

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

SYMBOL

STANDARD REFERENCE

ISO 7001

STANDARD TITLE

Public Information Symbol

SYMBOL TITLE

Recycling

EXPLANATORY TEXT

To indicate the location of a recycling bin or container.

SYMBOL

STANDARD REFERENCE

ISO15223-1: 2021

STANDARD TITLE

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

SYMBOL TITLE

Unique device identifier

EXPLANATORY TEXT

Indicates a carrier that contains unique device identifier information

SYMBOL

STANDARD REFERENCE

ISO 15223-1

STANDARD TITLE

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

SYMBOL TITLE

Not made with natural rubber latex

EXPLANATORY TEXT

Not made with natural rubber latex

SYMBOL

STANDARD REFERENCE

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

STANDARD TITLE

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

SYMBOL TITLE

Medical device

EXPLANATORY TEXT

Indicates the item is a medical device.