Symbol glossary

Medical device

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

Manufacturer

Indicates the medical device manufacturer, as defined in EU Directives 90/385/EEC, 93/42/EEC and 98/79/EC. SS-EN ISO 15223-1:2021

Date of manufacture

Indicates the date when the medical device was manufactured

Use-by date

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

Batch code

Indicates the manufacturer’s batch code so that the batch or lot can be identified. SS-EN ISO 15223-1:2021

Catalogue number

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

Sterilized using ethylene oxide

Indicates a medical device that has been sterilized using ethylene oxide

Sterilized using irradiation

Indicates a medical device that has been sterilized using irradiation

Single use

Indicates a medical device that is intended for one single use only

Single sterile barrier system

Indicates a single sterile barrier system

Single sterile barrier system with protective packaging inside

Indicates a single sterile barrier system with protective packaging inside

Non-sterile

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

Drops per millilitre

Indicates the number of drops per millilitre

Fluid path

Indicates the presence of a fluid path

One-way valve

Indicates a medical device with a valve that allows flow in only one direction

Non-pyrogenic

Indicated a medical device that is non-pyrogenic

Liquid filter with pore size

Indicates an infusion or transfusion system of the medical device that contains a filter of a particular nominal pore size

Caution

Indicates that caution is necessary when operating the device or control close to where the symbol is placed, or that the current situation needs operator awareness or operator action in order to avoid undesirable consequences

Consult instruction for use

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

Keep away from sunlight

Indicates a medical device that needs protection from light sources

Keep dry

Indicates a medical device that needs to be protected from moisture

Temperature limit

Indicates the temperature limits to which the medical device can be safely exposed. *The temperature shown in the symbol is assested by OMP QE team

Upper limit of temperature

Indicates the temperature limits to which the medical device can be safely exposed. *The temperature shown in the symbol is assested by OMP QE team

Do not use if package is damaged and consult instructions for use

Indicates that a medical device that should not be used if the package has been damaged or opened and that the user should consult the instructions for use for additional information

Do not open with knife

Symbol indicates that the user should not use a knife for opening the package due to the risk of damaging the medical device inside

Does not contain or there is no presence of natural rubber latex

Symbol indicates that the device does not contain or that there is no presence of natural rubber latex

Product does not DEHP

Symbol indicates that the device does not contain DEHP

Product does not PVC

Symbol indicates that the device does not contain PVC

4 ply

Indicates the number of plyes the swab has

8 ply

Indicates the number of plyes the swab has

12 ply

Indicates the number of plyes the swab has

3-way stopcock

Indicates a medical device that is a 3-way stopcock or has a 3-way stopcock component

Tube lenght

Indicates that the medical device includes tubing

Safe for use with pressure infusion equipment

Indicates that the medical device is safe or intended for use with pressure infusion equipment

Gravity feed only

Indicates that the medical device should only be used for gravity feed and that the device IS NOT safe or intended for use with pressure infusion equipment

Luer lock

Indicates a medical device that has a luer lock component

Needle free connector

Indicates a medical device that has a needle free connector component

Mask with Anti Reflection and Ear-loop

Symbol indicates that the mask has anti reflection properties and ear-loops

Mask with Anti Reflection and Tie-band

Symbol indicates that the mask has anti reflection properties and tie-band

Anti-fog properties

Symbol indicates that the mask has anti reflection properties

Tie-band

Symbol indicates that the mask has tie-band

Ear-loop

Symbol indicates that the mask has ear-loop

Extra wide

Symbol indicates that the mask is wider then the rest of the mask

Soft

Symbol indicates that the mask is made of softer material or that the material the mask is made of has soft properties then the rest of the mask

Splash resistant

Symbol indicates that the mask has splash resistant properties

Visor

Symbol indicates that the mask has visor

Latex free

Symbol indicates the composition of device not containing natural rubber latex or that its non-presence of is confirmed by a test

Basic procedures and wards

Recommendation for use in basic procedures and wards

Critical care

Recommendation for use in Critical care

Pharmacy

Recommendation for use in Pharmacy

Medical laboratory

Recommendation for use in Medical laboratory

Good protection against infection

Recommendation for use in more critical procedures and contact with blood

Sampling

Recommendation for use in sampling and injection work

Dental care

Recommendation for use in Dental care

Cleaning and surface disinfection

FSC certification ensures that products come from responsibly managed forests that provide environmental, social and economic benefits

Basic cleaning

Recommendation for use in Basic cleaning

Hairdressing

Recommendation for use in Hairdressing

Baby care

Recommendation for use in Baby care

Recycle symbol

Package is recyclable

Food safe

Suitable for handling food. If there are any restrictions they need to be beside the symbol. The restrictions need also to be translated

Micro-organisms and virus hazards

Protective gloves against dangerous chemicals and micro-organisms — Part 5: Terminology and performance requirements for micro-organisms risks

Flammable

Warning symbol for flammable substances, needs to be explained with additional text

Exclamation Mark

Warning symbol needs to be explained with additional text

Period after opening symbol

Symbol should also have the according nr of months written

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 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

Wash

Recommendation for use when washing patients

Food handling

Recommendation for use when handling food

Recycle symbol for corrugated fiberboard

Symbol indicates packaging is recyclable

Recycle symbol for non-corrugated fibreboard

Symbol indicates packaging is recyclable.

Protection against micro-organisms

Protective gloves against bacteria and fungi or against viruses, bacteria and fungi

Protection against dangerous chemicals

Protective glove against dangerous chemicals and micro-organisms complying with Type A, Type B or Type C requirements stated in standard EN ISO 374-1

Sterile

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

Do not resterilize

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

Contains or presence of natural rubber latex

Indicates the presence of dry natural rubber or natural rubber latex as a material of construction within the medical device or the packaging of medical device

Unique device identifier

Indicates a carrier that contains uniques device identifier information

Importer

Indicates the entity importing the medical device into the locale

Distributor

Indicates the entity distributing the medical device into the locale

Authorized representative in the European Community / European Union

Indicates the authorized representative in the European Community/ European Union

Health care professional use

Symbol indicates that the device is intended to be used by health care professionals

Contains or presence of Type IV allergen

Medical glove with residual risk of causing Type IV allergy