SYMBOL GLOSSORY
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
MD MEDICAL DEVICE
Indicates that the device is a medical device as defined in MDR 2017/745-
CE-MARK
Indicates manufacturer declaration that the product complies with the essential/ general safety & performance requirements of the relevant European medical device, health, safety and environmental protection legislations.
European Medical Devices Directive 93/42/EEC of 14 June 1993 (as amended by Directive 2007/47/EC). European Medical Device Regulation 2017/745
CE MARK WITH AITEX NOTIFIED BODY NUMBER
Indicates manufacturer declaration that the product complies with the essential/ general safety & performance requirements of the relevant European medical device, health, safety and environmental protection legislations.
European Medical Devices Directive 93/42/EEC of 14 June 1993 (as amended by Directive 2007/47/EC). European Medical Device Regulation 2017/745
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
COTOLOGUE 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
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
STERILE-EO
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 RE STERILIZE
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 DAMAGGED
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
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
KEY TO MATERIALS FOR DRAPES AND GOWNS
Our product illustrations are shown in colour in eg. Minerva, datasheets and the D-LAB BIOCLEAN product catalogue. This guide help you to understand what kind of material the drape or gown is made of.
ELASTIC FILM
Drapes
TRANSPARENT ELASTIC FILM
Drapes
INCISE / CONFORMABLE ADHESIVEEDGE
Drapes
IMPERMABLE
1-Ply material, coloured plastic
Drapes
TOP LAYER ABSORBENT AND IMPERMABLE
2-Ply material, non woven/plastic
Drapes
ABSORBENT AND IMPERMABLE
3-Ply material, non woven/plastic/tissue
Drapes
IMPERMABLE AND REVERSE LAYER ABSORBENT
2-Ply material, plastic up/non wovwn down
Drapes
FLUID REPELLENT MATERIAL (SONTARA)
Drapes & Gowns
FLUID REPELLENT MATERIAL (SONTARA)
2-Ply material, abserbent/plastic
Drapes & Gowns
ABSORBENT AND IMPERMABLE REINFORCEMENT
2-Ply material, abserbent/plastic
Drapes Reinforced & Gowns Sleeves
HIGHLY ABSORBENT PATCH
1-Ply material
Drapes