AUTH REPR IN EU COMMUN.

Indicates the authorized representative in the European Community.

Reference: 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

DATE OF MANUFACTURE

Indicates the date when the medical device was manufactured.

Reference: 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: 5.1.3

USE-BY DATE

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

Reference: 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

CE-MARK

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.

CE-MARK WITH SGS NOTIFIED BODY NUMBER

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.

BATCH CODE

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

CATALOGUE NUMBER

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

MANUFACTURER

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

Reference: 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: 5.1.1

STERILIZED USING ETHYLENE OXIDE

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

DO NOT USE IF PACKAGE IS DAMAGED

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.

KEEP AWAY FROM SUNLIGHT

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

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

DO NOT RE-USE

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