Symbol Glossary

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

Indicates the date when the medical

device was   manufactured

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 upper 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 5.3.6

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

Rx Only

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.