Glossary Symbols

Glossary Symbols

Symbols

Title & Designation No. of Standard

Title of Symbols

Reference No

Explanatory Text

Symbols

Title & Designation No. of Standard

ISO 15223-1

Title of Symbols

Do not re-use

Reference No

5.4.2

Explanatory Text

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

Symbols

Title & Designation No. of Standard

ISO 15223-1

Title of Symbols

Caution

Reference No

5.4.4

Explanatory Text

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

Symbols

Title & Designation No. of Standard

ISO 15223-1

Title of Symbols

Consult instructions for use

Reference No

5.4.3

Explanatory Text

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

Symbols

Authorized representative in the European Community

Title & Designation No. of Standard

ISO 15223-1

Title of Symbols

Authorized representative in the European Community

Reference No

5.1.2

Explanatory Text

Indicates the Authorized Representative in the European Community.

Symbols

Title & Designation No. of Standard

ISO 15223-1

Title of Symbols

Manufacturer

Reference No

5.1.1

Explanatory Text

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

Symbols

Title & Designation No. of Standard

ISO 15223-1

Title of Symbols

Batch code

Reference No

5.1.5

Explanatory Text

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

Symbols

Title & Designation No. of Standard

ISO 15223-1

Title of Symbols

Use-by date

Reference No

5.1.4

Explanatory Text

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

Symbols

Title & Designation No. of Standard

ISO 15223-1

Title of Symbols

Temperature limit

Reference No

5.3.7

Explanatory Text

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

Symbols

Title & Designation No. of Standard

ISO 15223-1

Title of Symbols

Keep away from sunlight

Reference No

5.3.2

Explanatory Text

Indicates a medical device that needs protection from light sources.

Symbols

Title & Designation No. of Standard

ISO 15223-1

Title of Symbols

Catalog number

Reference No

5.1.6

Explanatory Text

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

Symbols

Title & Designation No. of Standard

ISO 15223-1

Title of Symbols

Contains or presence of natural rubber latex

Reference No

5.4.5

Explanatory Text

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

Symbols

Prescription device labeling statement

Title & Designation No. of Standard

21 CFR 801.109(b)(1)

Title of Symbols

Prescription device labeling statement

Reference No

N/A

Explanatory Text

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

Symbols

Title & Designation No. of Standard

GHS Hazard Pictogram

Title of Symbols

Corrosive

Reference No

N/A

Explanatory Text

Indicates a corrosive substance that will destroy and damage other substances with which it comes into contact.

Symbols

Title & Designation No. of Standard

GHS Hazard Pictogram

Title of Symbols

Flammable

Reference No

N/A

Explanatory Text

Indicates a flammable substance that can be ignited very easily and will burn very vigorously when ignited.

Symbols

Title & Designation No. of Standard

GHS Hazard Pictogram

Title of Symbols

Irritant

Reference No

N/A

Explanatory Text

Indicates a material that can cause immediate health effects such as skin rashes or respiratory irritation.

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