Symbols Glossary

United States Title 21 of the Code of Federal Regulations (CFR) Part 801 - Labeling

SymbolSymbol TitleExplanatory TextStandard Reference
Prescription Use
Only
CAUTION: Federal (USA) law restricts
this device to sale by or on the order of a
licensed healthcare practitioner
Section 801.109 (b) (1)

ISO-15223-1 Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements

SymbolSymbol TitleExplanatory TextStandard Reference
Manufacturer SymbolManufacturerIndicates the medical device manufacturer.5.1.1
Authorized Representative in the European Community SymbolAuthorized
Representative in
the European
Community
Indicates the authorized representative in the
European Community / European Union.
5.1.2
Date of Manufacture SymbolDate of ManufactureIndicates the date when the medical device
was manufactured.
5.1.3
Use-by date SymbolUse-by dateIndicates the date after which the
medical device is not be used.
5.1.4
Batch Number SymbolBatch codeIndicates the manufacturer’s batch code so
that the batch or lot can be identified.
5.1.5
Catalog Number SymbolCatalogue numberIndicates the manufacturer’s catalogue
number so that the medical device can be
identified.
5.1.6
ImporterImporterIndicates the entity importing the medical
device into the locale.
5.1.8
Sterile SymbolSterileIndicates a medical device that has been
subjected to a sterilization process.
5.2.1
Sterilized by ethylene<br />
oxide treatment SymbolSterilized by
ethylene oxide
treatment
Indicates a medical device that has been
sterilized using ethylene oxide.
5.2.3
Sterilized using irradiation SymbolSterilized using
irradiation
Indicates a medical device that has been
sterilized using irradiation.
5.2.4
Do Not Re-sterilize SymbolDo Not Re-sterilizeIndicates a medical device that is not to be
re-sterilized.
5.2.6
Non-Sterile SymbolNon-SterileIndicates a medical device that has not been subjected to a sterilization process5.2.7
Do not use if package is damaged SymbolDo not use if
package is damaged
and consult instructions for use
Indicates 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.
5.2.8
Single Sterile Barrier SystemSingle Sterile Barrier SystemIndicates a Single Sterile Barrier System5.2.11
Double Sterile Barrier SystemDouble Sterile
Barrier System
Indicates a Double Sterile Barrier System5.2.12
Keep away from sunlight SymbolKeep away from
sunlight
Indicates a medical device that needs
protection from light sources.
5.3.2
Keep Dry SymbolKeep DryIndicates a medical device needs to be
protected from moisture.
5.3.4
Temperature Limit SymbolUpper limit of
temperature
Indicates the upper limit of temperature to which the medical device can be safely
exposed.
5.3.6
Temperature Limit SymbolTemperature limitIndicates the temperature limits to which the medical device can be safely exposed.5.3.7
pressure Limit SymbolHumidity LimitationIndicates the range of humidity to which the
medical device can be safely exposed.
5.3.8
pressure Limit SymbolAtmospheric
Pressure Limitation
Indicates the range of atmospheric pressure
to which the medical device can be safely
exposed.
5.3.9
Do not re-use SymbolDo not re-useIndicates a medical device that is intended
for one single use only.
5.4.2
Consult instructions for use SymbolConsult instructions
for use or consult
electronic
instructions for use.
Indicates the need for the user to consult the
instructions for use.
5.4.3
Caution SymbolCautionIndicates 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.
5.4.4
made with natural rubber latex SymbolContains latex or
presence of natural
rubber
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.
5.4.5
Not made with natural rubber latex SymbolNot made with
natural rubber latex
Indicates that neither the medical device nor
the packaging of the medical device contains
the presence of natural rubber latex.
5.4.5 and Annex B.2 and Guidance for Industry and US
Food and Drug Administration Staff - Recommendations
for Labeling Medical Products to Inform Users that the
Product or Product Container is not Made with Natural
Rubber Latex; Issued on December 2, 2014
Medical Device SymbolMedical DeviceIndicates the item is a Medical Device.5.7.7

European Medical Device Directive 93/42/EEC / European Medical Device Regulation 2017/745

SymbolSymbol TitleExplanatory TextStandard Reference
CE Mark 0050Article 17 /
Article 20
CE Conformity
Marking and Notified Body Number
Product conforms to the applicable requirements for a
medical device as set forth in the regulation and assessed
by the certifying notified body.
CE MarkArticle 17 /
Article 20
CE Conformity
Marking
Product conforms to the applicable requirements for
medical device as set forth in the regulation.

BS EN 15986:2011 – Medical devices – Symbol for use in the labelling of medical devices. Requirements for labelling of medical devices containing phthalates

SymbolSymbol TitleExplanatory TextStandard Reference
Does not contain
DEHP
Indicates a medical device that does not
contain the phthalate plasticizers DEHP
Annex B
Contains or
presence of
phthalate DEHP
Indicates presence of Bis (2-ethylexyl)
phthalate (DEHP).
A.2

IEC 60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

SymbolSymbol TitleExplanatory TextStandard Reference
Manufacturer SymbolDegree of Ingress
Protection Provided
by Enclosure
Degree of protection against the penetration
of solid foreign matter and liquids. Protected
against solid objects greater than or equal to
12.5 mm diameter and protected against the
effects of temporary immersion in water.
Table D.3, Symbol 2
IEC 60529
Manufacturer SymbolType BF applied partTo identify a type BF applied part complying
with IEC 60601-1.
Table D.1, Symbol 20

Other Symbols

SymbolSymbol TitleExplanatory TextStandard Reference
RecyclableProduct packaging is recyclable.N/A
Do not flushLikely to be used in a bathroom with
significant potential to be flushed.
N/A
Recycle: Electronic
Equipment
Do not dispose of this product in unsorted
municipal waste stream.
EN 50419
MR ConditionalItem with demonstrated safety in the MR
environment within defined conditions
including conditions for the static magnetic
field, the time-varying gradient magnetic
fields, and the radiofrequency fields.
ASTM F2503 Table 2

Therapeutic Goods Medical Device Regulation

SymbolSymbol TitleExplanatory TextStandard Reference
Australian
Sponsor
Indicates the authorized sponsor in the
Australian market.
N/A