Symbol glossary
Mölnlycke Health Care’s labelling is designed to meet all applicable international standards and regulations. Where possible, Mölnlycke Health Care 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.
CE-mark with BSI 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.
Prescription device
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.
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 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
Sterilized using irradiation
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
Sterilized using steam or dry heat
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
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 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
Humidity limitation
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
Atmospheric pressure limitation
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
This way up
To indicate correct upright position of the transport package.
ISO 7000 Graphical symbols for use on equipment — Registered symbols. Ref no: 0623.
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
Contains or presence of natural rubber latex
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
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
In-door use only
To identify electrical equipment designed primarily for indoor use.
IEC 60417 Graphical Symbols for Use on Equipment. Ref. no: 5957
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
Type BF applied part
To identify a type BF applied part complying with IEC 60601-1
IEC 60601-1, Medical electrical equipment — Part 1: General requirements for basic safety and essential performance. Table D.1, Symbol 20
Recycle: Electronic Equipment
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.
Marking of electrical and electronic equipment in accordance with Article 11(2) of Directive 2002/96/EC (WEEE)
Recycle
ISO 7001 Graphical symbols -- Public information symbols. Ref. no: PI PF 066
Green dot/Der Grüne Punkt
Packaging recovery organisation Europe
Flammable
United Nations Economic Commission for Europe (UNECE) Symbols
Hazardous to environment
Health Hazard/Hazardous to Ozone layer
Corrosive
Wash by hand
Maximum temperature by 40ºC. ISO 3758:2012 Textiles -- Care labelling code using symbols
Maximum washing temperature 60°C in normal condition
Washing in normal process. ISO 3758:2012 Textiles -- Care labelling code using symbols
Iron at maximum sole-plate temperature of 110°C without steam
Steam ironing may cause irreversible damage. ISO 3758:2012 Textiles -- Care labelling code using symbols
Tumble drying possible
Low temperature; exhaust temperature max. 60 °C. ISO 3758:2012 Textiles - Care labelling code using symbols
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
Do not wash
ISO 3758:2012 Textiles - Care labelling code using symbols
For low exuding wounds
For moderate exuding wounds
For highly exuding wounds
Shower proof
Move hand staff
Pouch
Direction of movement
Wound pad size square
Wound pad area Sacrum
Wound pad area Heel
Wound pad size square Wound pad size Flex
Abdominal Swab Gauze
Surgical Sponge Gauze
Surgical Swab Gauze
Abdominal swab, standard nonwoven
Surgical sponges, standard nonwoven
Surgical swab, standard nonwoven
Abdominal swab, special nonwoven
Abdominal swab with loop, special nonwoven
3 layer nonwoven fabric
1 layer nonwoven fabric
Gauze fabric
BARRIER® Product Illustrations - Colours guide for product illustrations
Key to materials for drapes and gownsOur product illustrations are shown in colour in eg. Minerva, data sheets and the BARRIER product catalogue. This guide helps you to understand what kind of material the drape or gown is made of.
Elastic film
Use: drapes
Transparent plastic film
Use: drapes
Incise film/conformable adhesive edge
Use: drapes
Impermeable
(1-ply material, coloured plastic)
Use: drapes and gowns
Top layer absorbent and impermeable
(2-ply material, non-woven/plastic)
Use: drapes
Absorbent and impermeable
(3-ply material, non-woven/plastic/tissue)
Use: drapes
Impermeable and reverse layer absorbent
(2-ply material, plastic up/non-woven down)
Use: drapes and gowns
Fluid repellent material (Sontara)
Use: drapes and gowns
Highly fluid repellent material (SMS)
Use: drapes and gowns
Absorbent and impermeable reinforcement
(2-ply material, absorbent/plastic)
Use: drapes (reinforced) and gowns (sleeves)
Highly absorbent patch
(1-ply Material)
Use: drapes
Highly absorbent and impermeable reinforcement
(2-ply material. eg. Drisite, plastic/absorbent)
Use: drapes (patches)
Extra feature (eg. foam for instruments)
Use: drapes
Adhesive edge
Use: drapes
Skin
Use: drapes
