Symbols Guide

Product Symbols Glossary - Symbols used on our product pages throughout the website

Symbol

Title of Symbol

Description of Symbol

perishable.jpg

Perishable

Item is Perishable

refrigerate.jpg

Refrigeration Required

Item requires Refrigeration

freezable.jpg

Freezable

Item is Freezable

hazmat.jpg

HazMat

HazMat Item - additional shipping charges may apply

nonstockitem.jpg

Nonstock

Item is NonStock - available to order, typical lead time is approximately 1-2 weeks from time of order placement, unless otherwise stated

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Country Sales Restriction

Item has a Country Sales Restriction - see product information below for more details

 

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

Symbol

Symbol Reference No

Title of Symbol

Description of Symbol

)

5.1.1

Manufacturer

Indicates the medical device manufacturer, as defined in EU Directives 90/385/EEC, 93/42/EEC and 98/79/EC.

+

5.1.2

Authorized representative in the European Community

Indicates the authorized representative in the European Community.

*

5.1.3

Date of Manufacture

Indicates the date when the medical device was manufactured.

9

5.1.4

Use by date

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

,

5.1.5

Batch Code

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

-

5.1.6

Catalog Number

Indicates the manufacturer's catalog number so that the medical device can be identified.

.

5.1.7

Serial Number

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

%

5.2.1

Sterile

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

&

5.2.2

Sterilized Using Aseptic Processing Techniques

Indicates a medical device that has been manufactured using accepted aseptic techniques.

$

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 re-sterilize

Indicates a medical device that is not to be re-sterilized.

(

5.2.7

Non-sterile

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

3

5.2.8

Do not use if package is damaged

Indicates a medical device that should not be used if the package has been damage or opened.

"

5.2.9

Sterile Fluid Path


Indicates the presence of a sterile fluid path within the medical device in cases when other parts of the medical device, including the exterior, might not be supplied sterile.

@

5.3.1

Fragile, handle with care

Indicates a device that can be broken or damaged if not handled carefully

B

5.3.2

Keep away from sunlight


Indicates a medical device that needs protection from light sources.

H

5.3.4

Keep dry

Indicates a medical device that needs to be protected from moisture.

5

5.3.5

Lower limit of temperature

Indicates the lower limit of temperature to which the medical device can be safely exposed. The temperature is indicated adjacent to the lower horizontal line.

6

5.3.6

Upper limit temperature

Indicates the upper limit of temperature to which the medical device can be safely exposed. The temperature is indicated adjacent to the upper horizontal line.

7

5.3.7

Temperature limit

Indicates the upper and lower limits of temperature to which the medical device can be safely exposed. The temperature is indicated adjacent to the horizontal lines.

0

5.3.8

Storage Humidity Range

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

1

5.3.9

Atmospheric Pressure

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

L

5.4.1

Biological risk

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

2

5.4.2

Do not re-use

Indicates a medical device that is intended for one use or for use on a single patient during a single procedure.

A

5.4.3

Caution


Indicates that the instructions for use contain important cautionary information such as warnings and precautions that cannot, for a variety of reasons, be presented on the medical device itself.

;

5.4.4

Caution

Indicates the need for the user to consult the instructions for use for important cautionary information such as warnings and precautions that cannot, for a variety of reasons, be presenting on the medical device itself.

<

5.4.5

Contains of presence of natural rubber latex

Indicates the presence of natural rubber or dry natural rubber latex as a material of construction within the medical device or the packaging of a medical device which may cause allergic reactions.

D

5.5.1

In vitro diagnostic medical


Indicates a medical device that is intended to be used as an in vitro diagnostic medical device

E

5.5.2

Control

Indicates a control material that is intended to verify the performance characteristics of another medical device.

F

5.5.3

Negative Control

Indicates a control material that is intended to verify the results in the expected negative range.

G

5.5.4

Positive Control

Indicates a control material that is intended to verify the results in the expected negative range.

=

5.5.5

Contains Sufficient for tests

Indicates the total number of IVD tests that can be performed with the IVD.

4

5.5.6

For IVD performance evaluation only

Indicates an IVD device that is intended to be used only for evaluating its performance characteristics before it is placed on the market for medical diagnostic use

K

5.6.2

Fluid Path

Indicates the presence of a fluid path.

J

5.6.3

Non-pyrogenic

Indicates a medical device that is non-pyrogenic.

:

5.6.4

Drops Per Millilitre

Indicates the number of drops per milliliter. NOTE: The number of drops per milliliter is specified; 20 is shown as an example and should be replaced by the appropriate number of drops per milliliter.

I

5.6.5

Liquid Filter with Pore Size

Indicates an infusion or transfusion system of the medical device that contains a filter of a particular nominal pore size. NOTE: The nominal pore size of the filter is specified; 15 is shown as an example and should be replaced by the appropriate pore size.

>

5.7.1

Patient Number

Indicates a unique number associated with an individual patient

 

Symbols Not Derived from Standards

Symbol

Symbol Reference No

Title of Symbol

Description of Symbol

8

765/2008/EC 768/2008/EC MDD 93/42/EEC Articles 4,11,12,17, Annex II )

Conformité Européene or European Conformity

Signifies European technical conformity.