Symbols Glossary

ISO 15223-1:2016 – Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements

SymbolReferenceTitleDescription
Manufacturer Symbol5.1.1ManufacturerIndicates the medical device manufacturer, as defined in EU Directives 90/385/EEC, 93/42/EEC, and 98/79/EC
Authorized Representative in the European Community Symbol5.1.2Authorized Representative in the European CommunityIndicates the authorized representative in the European Community.
Date of Manufacture Symbol5.1.3Date of ManufactureIndicates the date when the medical device was manufactured
Use-by date Symbol5.1.4Use-by dateIndicates the date after which the medical device is not be used.
Batch Number Symbol5.1.5Batch NumberIndicates the manufacturer’s batch code so that the batch or lot can be identified.
Catalog Number Symbol5.1.6Catalog NumberIndicates the manufacturer’s catalogue number so that the medical device can be identified
Sterile Symbol5.2.1SterileIndicates a medical device that has been subjected to a sterilization process
Sterilized by ethylene<br />
oxide treatment Symbol5.2.3Sterilized by ethylene
oxide treatment
Indicates a medical device that has been sterilized using ethylene oxide.
Sterilized using irradiation Symbol5.2.4Sterilized using irradiationIndicates a medical device that has been sterilized using irradiation.
Do Not Re-sterilize Symbol5.2.6Do Not Re-sterilizeIndicates a medical device that is not to be
re-sterilized.
Non-Sterile Symbol5.2.7Non-SterileIndicates a medical device that has not been subjected to a sterilization process
Do not use if package is damaged Symbol5.2.8Do not use if package is damagedIndicates a medical device that should not be used if the package has been damaged or opened.
Keep away from sunlight Symbol5.3.2Keep away from sunlightIndications a medical device that needs protection from light sources.
Keep Dry Symbol5.3.4Keep DryIndicates a medical device needs to be protected from moisture.
Temperature Limit Symbol5.3.7Temperature limitIndicates the temperature limits to which the medical device can be safely exposed.
Do not re-use Symbol5.4.2Do not re-useIndicates a medical device that is intended for one use, or for use on a single patient during a single procedure.
Consult instructions for use Symbol5.4.3Consult instructions for useIndicates the need for the user to consult the instructions for use
Caution Symbol5.4.4CautionIndicates 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.
Not made with natural rubber latex Symbol5.4.5 and
Annex B.2 and
Guidance for Industry and
US Food and Drug
Administration Staff
Not made with natural rubber latexIndicates that neither the medical device nor the packaging of the medical device contains the presence of natural rubber latex

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

SymbolReferenceTitleDescription
CE Mark 0050Article 17CE Conformity Marking and Notified Body NumberProduct conforms to the applicable requirements for a medical device as set forth in the regulation and assessed by the certifying notified body.
CE MarkArticle 17CE Conformity MarkingProduct conforms to the applicable requirements for medical device as set forth in the regulation and assessed by the certifying notified body
Single Sterile Barrier SystemAnnex 1, 23.3(a) Single Sterile Barrier
System
Sterile barrier system
Double Sterile Barrier SystemAnnex 1, 23.3(a) Double Sterile Barrier
System
Double entry package with two sterile barrier systems
Medical Device SymbolAnnex 1, 23.2(q) Medical DeviceDesignation that the item is classified as a Medical Device

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

SymbolReferenceTitleDescription
BS EN 15986:2011
EN 15986:2011(E)
Annex B
Does not contain DEHPIndicates a medical device that does not contain the phthalate plasticizers DEHP
BS EN 15986:2011
Reference no. A.5
Contains or presence of phthalate DEHPIndicates presence of Bis (2-ethylexyl) phthalate (DEHP).

United States’ Title 21 of the Code of Federal Regulations (CFR) Section 801.109(b)(1)

SymbolReferenceTitleDescription
21 CFR Section 801.109 (b) (1) and United States Food and Drug Administration Guidance for Industry – Alternative to Certain Prescription Device Labeling Requirements, Issued on January 21, 2000Prescription Use OnlyCAUTION: Federal (USA) law restricts this device to sale by or on the order of a licensed healthcare practitioner

Union of Orthodox Jewish Congregations of America (the “Orthodox Union”) certification requirements for kosher products

SymbolReferenceTitleDescription
Kosher Requirements per Union of Orthodox Jewish Congregations of AmericaCertified KosherCertified Kosher per the Union of Orthodox Jewish Congregations of America as Pareve (contains neither milk or meat ingredients)

Other Symbols

SymbolReferenceTitleDescription
NAMade in the USAAll or virtually all significant parts and processing of this product are of U.S. origin.
NAAustralian SponsorIndicates the authorized sponsor in the Australian market.

Last Updated 6/8/2021