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Product Symbol Glossary

Loxtay PPE’s labelling is designed to meet all applicable international standards and regulations. Where possible, Loxtay PPE 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

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

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

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

SERIAL NUMBER

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

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.

MEDICAL DEVICE

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

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


STERILIZED USING ETHYLENE OXIDE

Indicates a medical device that is not to be re-sterilized..
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

NON-STERILE

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

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

FRAGILE, HANDLE WITH CARE

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

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

LOWER LIMIT OF TEMPERATURE

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

UPPER LIMIT OF TEMPERATURE

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
TEMPERATURE LIMIT

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

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

CONSULT INSTRUCTIONS FOR USE

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

CAUTION

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

REFER TO INSTRUCTION MANUAL/BOOKLET

Follow instructions for use.
IEC 60601-1:2005/ COR1:2006 Medical electrical equipment — Part 1: General requirements for basic safety and essential performance. Table D.2, Symbol 10

CLASS II EQUIPMENT

To identify equipment meeting the safety requirements specified for Class II equipment
IEC 60601-1, Medical electrical equipment — Part 1: General requirements for basic safety and essential performance. Table D.1, Symbol 9

FLAMMABLE

United Nations Economic Commission for Europe (UNECE) Symbols
HAZARDOUS TO ENVIRONMENT

DO NOT BLEACH

ISO 3758:2012 Textiles — Care labelling code using symbols

DO NOT DRY CLEAN

ISO 3758:2012 Textiles – Care labelling code using symbols

DO NOT IRON

ISO 3758:2012 Textiles — Care labelling code using symbols

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