Standard: ISO 15223-1, Medical Devices - Symbols to be used with medical device labels, labeling, and

information to be supplied – Part 1: General requirements

Symbol

Reference No

Title of Symbol Description of Symbol

5.1.1 Manufacturer Indicates the medical device manufacturer

5.1.2 Authorized

representative in the

European Community/

European Union

Indicates the authorized representative in the European

Community/ European Union

5.1.3 Date of manufacture Indicates the date when the medical device was

manufactured

5.1.4 Use-by date Indicates the date after which the medical device is not to

be used

5.1.5 Lot Number Indicates the manufacturer’s batch code so that the batch

or lot can be identied

5.1.6 Catalogue number Indicates the manufacturer’s catalogue number so that the

medical device can be identied

5.1.7 Serial number Indicates the manufacturer’s serial number so that a

specic medical device can be identied

5.2.2 Sterilized using aseptic

processing techniques

Indicates a medical device that has been manufactured

using accepted aseptic techniques.

5.2.3 Sterilized using

ethylene oxide

Indicates a medical device that has been sterilized using

ethylene oxide

5.2.4 Sterilized using

irradiation

Indicates a medical device that has been sterilized

using irradiation

5.2.5 Sterilized using steam

or dry heat

Indicates a medical device that has been sterilized using

steam or dry heat.

5.2.6 Do not resterilize Indicates a medical device that is not to be resterilized

Standard: ISO 15223-1, Medical Devices - Symbols to be used with medical device labels, labeling, and

information to be supplied – Part 1: General requirements

Symbol

Reference No

Title of Symbol Description of Symbol

5.2.7 Non-sterile Indicates a medical device that has not been subjected

to a sterilization process

5.2.8 Do not use if package is

dam-aged 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

5. 2.11 Single sterile

barrier system

Indicates a single sterile barrier system

5.2.12 Double sterile

barrier system

Indicates two sterile barrier systems

5.2.13 Single sterile barrier

system with protective

packaging inside

Indicates a single sterile barrier system with protective

packaging inside

5.2.14 Single sterile barrier

system with protective

packaging outside

Indicates a single sterile barrier system with protective

packaging outside

5.2.3 and

5. 2.11

Single sterile barrier

system; sterilized using

ethylene oxide

Indicates a single sterile barrier system and sterilized using

ethylene oxide

5.2.3 and

5.2.12

Double sterile barrier

system; sterilized using

ethylene oxide

Indicates two sterile barrier systems and sterilized using

ethylene oxide

5.2.4 and

5. 2.11

Single sterile barrier

system; sterilized using

irradiation

Indicates a single sterile barrier system and sterilized

using irradiation

5.3.1 Fragile, handle with care Indicates a medical device that can be broken or damaged

if not handled carefully

5.3.2 Keep away from sunlight Indicates a medical device that needs protection from

light sources

5.3.4 Keep dry Indicates a medical device that needs to be protected

from moisture

Standard: ISO 15223-1, Medical Devices - Symbols to be used with medical device labels, labeling, and

information to be supplied – Part 1: General requirements

Symbol

Reference No

Title of Symbol Description of Symbol

5.3.5 Lower limit of

temperature

Indicates the lower limit of temperature to which the

medical device can be safely exposed

5.3.6 Upper limit of

temperature

Indicates the upper limit of temperature to which the

medical device can be safely exposed

5.3.7 Temperature limit Indicates the temperature limits to which the medical

device can be safely exposed

5.3.8 Humidity limitation Indicates the range of humidity to which the medical

device can be safely exposed

5.4.2 Do not re-use Indicates a medical device that is intended for one single

use only

5.4.3 Consult instructions for

use or consult electronic

instructions for use

Indicates the need for the user to consult the instructions

for use

5.4.4 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

5.4.5 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

5.4.8 Contains biological

material of animal origin

Indicates a medical device that contains biological tissue,

cells, or their derivatives, of animal origin

5.4.10 Contains hazardous

substances

Indicates a medical device that contains substances that

can be carcinogenic, mutagenic, reprotoxic (CMR), or

substances with endocrine disrupting properties

5.6.3 Non-pyrogenic Indicates a medical device that is non-pyrogenic

5.7.7 Medical Device Indicates the item is a medical device