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Symbol glossary

Release Time:2020-04-25     Hits:28

Zhende’s labelling is designed to meet all applicable international standards and regulations. Where possible, Zhende 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 labelling and the meaning of the symbol is provided in this document.

 

Manufacturer

 

 

Authorized representative in European Community

 

 

Date of Manufacture

 

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

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.

Indicates the authorized representative in the European Community.

SS-EN ISO 15223-1:2016 Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements (ISO 15223-1:2016) Ref no: 5.1.2

Indicates the date when the medical device was manufactured.

SS-EN ISO 15223-1:2016 Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements (ISO 15223-1:2016) Ref no: 5.1.2

 

Use-by date

 

 

Batch code

 

 

Catalogue number

 

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

SS-EN ISO 15223-1:2016 Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements (ISO 15223-1:2016). Ref no: 5.1.4

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

SS-EN ISO 15223-1:2016 Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements (ISO 15223-1:2016). Ref no: 5.1.5

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

SS-EN ISO 15223-1:2016 Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements (ISO 15223-1:2016. Ref no: 5.1.6)

 

CE-mark

 

 

CE-mark with notified body number

 

 

Medical device

 

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

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.

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

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

Indicates that the device is a medical device as defined in MDR 2017/745

 

 

Sterilized using ethylene oxide

 

 

Sterilized using irradiation

 

 

Sterilized using steam or dry heat

 

Indicates a medical device that has been sterilized using ethylene oxide.

SS-EN ISO 15223-1:2016 Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements (ISO 15223-1:2016). Ref no: 5.2.3

Indicates a medical device that has been sterilized using irradiation.

SS-EN ISO 15223-1:2016 Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements (ISO 15223-1:2016). Ref no: 5.2.4

Indicates a medical device that has been sterilized using steam or dry heat.

SS-EN ISO 15223-1:2016 Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements (ISO 15223-1:2016). Ref no: 5.2.5

 

Non-sterile

 

 

Do not use if package is damaged

 

 

Keep away from sunlight

 

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

SS-EN ISO 15223-1:2016 Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements (ISO 15223-1:2016). Ref no: 5.2.7

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

SS-EN ISO 15223-1:2016 Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements (ISO 15223-1:2016). Ref no: 5.2.8

Indicates a medical device that needs protection from light sources.

SS-EN ISO 15223-1:2016 Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements (ISO 15223-1:2016). Ref no: 5.3.2

 

Keep dry

 

 

Temperature limit

 

 

Do not re-use

 

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

SS-EN ISO 15223-1:2016 Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements (ISO 15223-1:2016). Ref no: 5.3.4

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

SS-EN ISO 15223-1:2016 Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements (ISO 15223-1:2016). Ref no: 5.3.7

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

SS-EN ISO 15223-1:2016 Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements (ISO 15223-1:2016). Ref. no: 5.4.2

 

Consult instructions for use

 

 

Caution

 

 

Contains or presence of natural rubber latex

 

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

SS-EN ISO 15223-1:2016 Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements (ISO 15223-1:2016). Ref. no: 5.4.3

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.SS-EN ISO 15223-1:2016 Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements (ISO 15223-1:2016). Ref. no: 5.4.4.

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.

SS-EN ISO 15223-1:2016 Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements (ISO 15223-1:2016) Ref. no: 5.4.5.

 

Catalogue number

 

 

Sterile

 

 

Sterilized using aspectic processing techniques

 

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

SS-EN ISO 15223-1:2016 Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements (ISO 15223-1:2016). Ref no: 5.1.7

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

SS-EN ISO 15223-1:2016 Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements (ISO 15223-1:2016). Ref no: 5.2.1

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

SS-EN ISO 15223-1:2016 Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements (ISO 15223-1:2016). Ref no: 5.2.2

 

Do not resterilize

 

 

Sterile fluid path

 

 

Fragile, handle with care

 

Indicates a medical device that is not to be resterilized.

SS-EN ISO 15223-1:2016 Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements (ISO 15223-1:2016). Ref no: 5.2.6

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.

SS-EN ISO 15223-1:2016 Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements (ISO 15223-1:2016). Ref no: 5.2.9

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

SS-EN ISO 15223-1:2016 Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements (ISO 15223-1:2016). Ref no: 5.3.1

 

Protect from heat and radioactive sources

 

 

Lower limit of temperature

 

 

Upper limit of temperature

 

Indicates a medical device that needs protection from heat and radioactive sources.

SS-EN ISO 15223-1:2016 Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements (ISO 15223-1:2016). Ref no: 5.3.3

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

SS-EN ISO 15223-1:2016 Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements (ISO 15223-1:2016). Ref no: 5.3.5

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

SS-EN ISO 15223-1:2016 Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements (ISO 15223-1:2016). Ref no: 5.3.6

 

Humidity limitation

 

 

Atmospheric pressure limitation

 

 

Biological risks

 

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

SS-EN ISO 15223-1:2016 Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements (ISO 15223-1:2016). Ref no: 5.3.8

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

SS-EN ISO 15223-1:2016 Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements (ISO 15223-1:2016). Ref no: 5.3.9

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

SS-EN ISO 15223-1:2016 Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements (ISO 15223-1:2016). Ref no: 5.4.1

 

This way up

 

 

Recycle

 

 

 

 

 

To indicate correct upright position of the transport package.

ISO 7000 Graphical symbols for use on equipment — Registered symbols. Ref no: 0623.

ISO 7001 Graphical symbols -- Public information symbols. Ref. no: PI PF 066