Manufacturer

Indicates the medical device manufacturer

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

ISO 15223-1, Reference 5.1.1

Authorised representative in the European Community

Indicates the authorized representative in the European Community/

European Union

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

ISO 15223-1, Reference 5.1.2

Date of manufacture

To identify the country of manufacture

of products

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

ISO 15223-1, Reference 5.1.3

Country of manufacture

To identify the country of manufacture

of products

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

ISO 15223-1, Reference 5.1.11

Use-by date

Indicates the date after which the

medical device is not to be used

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

ISO 15223-1, Reference 5.1.4

Medical device

Indicates the item is a medical device

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

ISO 15223-1, Reference 5.7.7

Unique device identifier

Indicates a carrier that contains unique device Identifier information

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

ISO 15223-1, Reference 5.7.10

Model number

Indicates the model number

or type number of a product

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

ISO 15223-1, Reference 5.1.10

Batch code

Indicates the manufacturer’s batch code so that the

batch or lot can be identified

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

ISO 15223-1, Reference 5.1.5

Catalogue number

Indicates the manufacturer’s catalogue number so that

the medical device can be identified

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

ISO 15223-1, Reference 5.1.6

Serial number

Indicates the manufacturer’s serial number so that a

specific medical device can be identified

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

ISO 15223-1, Reference 5.1.7

Importer

Indicates the entity importing

the medical device into the locale

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

ISO 15223-1, Reference 5.1.8

Distributor

Indicates the entity

distributing the medical device into the locale

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

ISO 15223-1, Reference 5.1.9

Sterile

Indicates a medical device

that has been subjected to a sterilization process

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

ISO 15223-1, Reference 5.2.1

Sterilized using ethylene oxide

Indicates a medical device

that has been sterilized using ethylene oxide

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

ISO 15223-1, Reference 5.2.3

Sterilized using irradiation

Indicates a medical device

that has been sterilized using irradiation

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

ISO 15223-1, Reference 5.2.4

Sterilized using Steam or Dry heat

Indicates a medical device that has been

sterilized using steam or dry heat

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

ISO 15223-1, Reference 5.2.5

Single sterile barrier system

Indicates a single sterile barrier system

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

ISO 15223-1, Reference 5.2.11

Double sterile barrier system

Indicates two sterile barrier systems

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

ISO 15223-1, Reference 5.2.12

Single sterile barrier system with protective packaging inside

Indicates a single sterile barrier system with protective packaging inside

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

ISO 15223-1, Reference 5.2.13

Single sterile barrier system with protective packaging outside

Indicates a single sterile barrier system with protective packaging outside

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

ISO 15223-1, Reference 5.2.14

Do not resterilize

Indicates a medical device that is not to be resterilized

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

ISO 15223-1, Reference 5.2.6

Non-sterile

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

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

ISO 15223-1, Reference 5.1.7

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 NOTE 1 This symbol can also mean “Do not use if the product sterile barrier system or its packaging is compromised”. NOTE 2 For products that do not have instructions for use, the recommendation to consult them does not apply.

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

ISO 15223-1, Reference 5.2.8

Keep away from sunlight

Indicates a medical device that needs protection from light sources

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

ISO 15223-1, Reference 5.3.2

Protect from heat and radioactive sources

Indicates a medical device that needs protection from heat and radioactive sources

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

ISO 15223-1, Reference 5.3.3

Keep dry

Indicates a medical device that needs to be protected from moisture

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

ISO 15223-1, Reference 5.3.4

Lower limit of temperature

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

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

ISO 15223-1, Reference 5.3.5

Upper limit of temperature

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

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

ISO 15223-1, Reference 5.3.6

Temperature limit

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

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

ISO 15223-1, Reference 5.3.7

Humidity limitation

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

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

ISO 15223-1, Reference 5.3.8

Atmospheric pressure limitation

Indicates the range of atmospheric pressure to which the medical device can be safely exposed

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

ISO 15223-1, Reference 5.3.9

Biological risks

Indicates that there are potential biological risks associated with the medical device

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

ISO 15223-1, Reference 5.4.1

Do not re-use

Indicates a medical device that is intended for one single use only

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

ISO 15223-1, Reference 5.4.2

Single patient multiple use

Indicates a medical device that may be used multiple times (multiple procedures) on a single patient

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

ISO 15223-1, Reference 5.4.12

Consult instructions for use or consult electronic instructions for use

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

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

ISO 15223-1, Reference 5.4.3

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

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

ISO 15223-1, Reference 5.4.4

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

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

ISO 15223-1, Reference 5.4.5

Contains hazardous substance

Indicates a medical device that contains or incorporates human blood or plasma derivatives

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

ISO 15223-1, Reference 5.4.10

Prescription use only

Labeling; Prescription devices

21 CFR 801.109

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

CE-Mark

Indicates manufacturer declaration that the product complies with the essential/ general safety & performance requirements of the relevant European medical device, health, safety and environmental protection legislations.

European Medical Devices Directive 93/42/EEC of 14 June 1993 (as amended by Directive 2007/47/EC). European Medical Device Regulation 2017/745

European conformity (CE) mark for Class I non-sterile medical devices.

CE-Mark with notified body number

Indicates manufacturer declaration that the product complies with the essential/ general safety & performance requirements of the relevant European medical device, health, safety and environmental protection legislations.

European Medical Devices Directive 93/42/EEC of 14 June 1993 (as amended by Directive 2007/47/EC). European Medical Device Regulation 2017/745

European conformity (CE) mark with Notified Body identification number for Class Im, Ir, Is, IIa, IIb, III medical devices.