Symbol

Title

Standard

Reference Number

Description

Manufacturer

ISO 7000 Graphical symbols for use on equipment – Registered Symbols

Reg. No. 3082

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

Authorized representative in the European Community

ISO 15223-1 Medical devices – Symbols to be used with medical device labels – General requirements

Section 5.1.2

Indicates the Authorized representative in the European Community.

Date of Manufacture

ISO 7000 Graphical symbols for use on equipment – Registered Symbols

Reg. No. 2497

Indicates the date when the medical device was manufactured.

Use-By Date

ISO 7000 Graphical symbols for use on equipment – Registered Symbols

Reg. No. 2607

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

Batch Code

ISO 7000 Graphical symbols for use on equipment – Registered Symbols

Reg. No. 2492

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

Catalogue Number

ISO 7000 Graphical symbols for use on equipment – Registered Symbols

Reg. No. 2493

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

Serial Number

ISO 7000 Graphical symbols for use on equipment – Registered Symbols

Reg. No. 2498

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

Non-Sterile

ISO 7000 Graphical symbols for use on equipment – Registered Symbols

Reg. No. 2609

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

Do not use if package is damaged

ISO 7000 Graphical symbols for use on equipment – Registered Symbols

Reg. No. 2606

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

Fragile, handle with care

ISO 7000 Graphical symbols for use on equipment – Registered Symbols

Reg. No. 0621

Indicates a medical device that can be broken or damaged if not handled correctly.

Keep away from sunlight

ISO 7000 Graphical symbols for use on equipment – Registered Symbols

Reg. No. 0624

Indicates a medical device that needs protection from light sources.

Keep dry

ISO 7000 Graphical symbols for use on equipment – Registered Symbols

Reg. No. 0626

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

Lower limit of temperature

ISO 7000 Graphical symbols for use on equipment – Registered Symbols

Reg. No. 0534

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

Upper limit of temperature

ISO 7000 Graphical symbols for use on equipment – Registered Symbols

Reg. No. 0533

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

Temperature limit

ISO 7000 Graphical symbols for use on equipment – Registered Symbols

Reg. No. 0632

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

Do not re-use

ISO 7000 Graphical symbols for use on equipment – Registered Symbols

Reg. No. 1051

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

Consult instructions for use

ISO 7000 Graphical symbols for use on equipment – Registered Symbols

Reg. No. 1641

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

Caution

ISO 7000 Graphical symbols for use on equipment – Registered Symbols

Reg. No. 0434A

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 presented on the medical device itself.

Alternating Current

ISO 7000 Graphical symbols for use on equipment – Registered Symbols

Reg. No. 5032

To indicate on the rating plate that the equipment is suitable for alternating current only; to identify relevant terminals.

Direct current

IEC 60417 Graphical symbols for use on equipment

Reg. No. 5031

To indicate on the rating plate that the equipment is suitable for direct current only; to identify relevant terminals.

Both direct and alternating current

IEC 60417 Graphical symbols for use on equipment

Reg. No. 5033

To indicate on the rating plate that the equipment is suitable for both direct and alternating current (universal); to identify relevant terminals.

Class II equipment

IEC 60417 Graphical symbols for use on equipment

Reg. No. 5172

To identify equipment meeting the safety requirements specified for Class II equipment according to IEC 61140.

Type BF applied part

IEC 60417 Graphical symbols for use on equipment

Reg. No. 5333

To identify a type BF applied part complying with IEC 60601-1.

General Warning Sign

ISO 7010 Graphical symbols – Safety colours and safety signs – Registered safety signs

Reg. No. W001

To signify a general warning.

Refer to instruction manual/booklet

ISO 7010 Graphical symbols – Safety colours and safety signs – Registered safety signs

Reg. No. M002

To signify that the instruction manual/booklet must be read.

Conformité Européene
or
European Conformity

Council Directive 93/42/EEC of 14 June 1993 concerning medical devices

Article 17

Indicates manufacturer declaration that the product complies with the essential requirements of the relevant European health, safety and environmental protection legislation.