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) To indicate connection to the mains, at least for mains switches, or their positions, and all those cases where safety is involved. 

 

5008

 “OFF”(power) To indicate disconnection from the mains, at least for main switches, or their positions, and all those cases where safety is involved.

 

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.

 

5988

Three-phase alternating current  Indicating the rating plate that the equipment is suitable for three phase alternating current only; to identify relevant terminals.
   Three-phase alternating current with neutral conductor  Indicating the rating plate that the equipment is suitable for three phase alternating current with neutral conductor only; to identify relevant terminals.

 

5032

 Protective earth; protective ground  To identify any terminal which is intended for connection to an external conductor for protection against electric shock in case of fault, or the terminal of a protective earth (ground) electrode

 

 Computer network  To identify the computer network itself or to indicate the connecting terminals of the computer network

 

5333

 Type BF applied part  To identify a type BF applied part complying with IEC 60601-1
   Input; entrance  Indicating an entrance (e.g. hydraulic pump).
   Output; exit  Indicating an exit (e.g. hydraulic pump).

 

 STANDARD: ISO 7010, Graphical symbols for electrical equipment in medical practice 

Symbol/Symbol Ref. No.Title of SymbolDescription of SymbolAdditional Ref.

 

M002

 

Refer to instruction manual/booklet To signify that the instruction manual/booklet must be read IEC 60601-1

 

P001

Template for constructing a prohibition sign  Note - This safety sign cannot be used on its own and requires a supplementary sign to give further information about the action which is prohibited. 

ISO3864-1 (Fig1)

 

 

W001

 

 General warning sign To signify a general warning. IEC TR 60878 Note: On medical equipment, this safety sign shall only be used if there is no other safety sign for the corresponding hazard. If possible, the hazard or the appropriate precaution should be indicated.
 

 

W012

 

 

Warning; electricity 

 

Caution risk of electric shock or Attention Dangerous Voltage  

 

 

 STANDARD: BS EN 50419, Marking of Electrical and Electronic Equipment in accordance with Article 11(2) of the EC Directive 2002/96/EC (WEEE)

Symbol Title of Symbol Description of Symbol
  Crossed out Wheelie-Bin Identifies product that is subject to the European Union’s Waste Electrical and Electronic Equipment (WEEE) 2012/19/EU Directive for recycling of electronic equipment.
The black bar underneath the bin indicates goods that are placed on the market after 13 August 2005.

 

Other Markings/Symbols

 

Symbol Title of Symbol Description of Symbol
  21 CFR 801.109 Indicates that the product is a medical device as defined in 21 CFR 820.3(l) and Federal Law (USA) restricts this device to sale by or on the order of a physician (21 CFR 801.109)
  European Medical Devices Directive 93/42/EEC of 14 June 1993 (as amended by Directive 2007/47/EC)
As described in Article 17 of the Directive

Conformité Européene or European Conformity

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

 

 
  Quantity Indicates the total number of products provided in a package.
  ISO 780 Packaging - Distribution packaging - Graphical symbols for handling and storage of packages This way up

 

 

 

 

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