Insightec’s product labeling is designed to meet all applicable domestic and international standards and regulations. Where possible, Insightec adopted the use of symbols to communicate requirements, product characteristics and provide guidance on handling and storage to the user. A compiled listing of symbols that may appear on the product labeling and the meaning of the symbol is provided in this document.

STANDARD: BS EN ISO 15223-1: Medical Devices - Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements

Symbol/Symbol Ref. No.Title of SymbolDescription of SymbolISO 7000 Reg. No.

 

5.1.1

 Manufacturer  Indicates the medical device manufacturer, as defined in EU Directives 90/385/EEC, 93/42/EEC and 98/79/EC  3082

 

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  2497

 

5.1.4

Use by date

 

 Indicates the date after which the device is not to be used  2492

 

5.1.5

 Batch code  

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

 2492

 

5.1.6

 Catalog number  Indicates the manufacturer’s catalog number so that the medical device can be identified  2493

 

5.1.7

Serial number  Indicates the manufacturer’s serial number so that a specific medical device can be identified 2498 

 

5.2.8

Do not use if package is damaged

 

Indicates a device that should not be used if the package has been damaged or openedDo not use if package is damaged

 2506

 

   5.3.1

Fragile, handle

with care 

 Indicates a device that can be broken or damaged if not handled carefully 0621 

5.3.2

Keep away from sunlight 

 Indicates a medical device that needs protection from light sources  0624

 

5.3.4

Keep dry 

 Indicates a medical device that needs to be protected from moisture  0626

 

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 0534 

5.3.6

Upper limit of 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 0533 

 

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 0632 

 

5.3.8

Humidity limitation 

 

Indicates the range of humidity to which the device can be safely exposed. The humidity limitation is indicated adjacent to the upper and lower horizontal lines

2620 

 

5.4.2

Do not re-use 

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

1051

 

5.4.3

Consult instructions for use 

Indicates the need for the user to consult the instruction for use 1641

 

5.4.4

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. 0434

 

5.4.5 and Annex B

(Section B2)

Product is not made with natural rubber latex 

Indicates that natural rubber latex was not used in the manufacturing of the product, its container, or its packaging -

 

STANDARD: IEC 60417, Graphical Symbols For Use On Equipment 

Symbol/Symbol Ref. No.  Title of Symbol  Description of Symbol

 

5007

 “ON”(power)  Toindicateconnectiontothemains,atleastformainsswitches,ortheirpositions,andallthosecaseswheresafetyisinvolved.

 

5008

 “OFF”(power)  Toindicatedisconnectionfromthemains,atleastformainswitches,ortheirpositions,andallthosecaseswheresafetyisinvolved.

 

5010

 “ON”/”OFF”

(push-push)

To indicate connection to or disconnection from the mains, at least for mains switches or their positions, and all those cases where safety is involved. Each position, “ON” or “OFF”, is a stable position

 

5032

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

 

 

 

 

 

 

 

 

 

 

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