ISO
Symbols Glossary

Symbol





Standard and Reference #Standard TitleFDA Recognition #Date of Entry
TitleDescription
EN ISO 15223-1:2021 Reference #5.1.1Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements5-13412/20/2021ManufacturerIndicates the medical device manufacturer.
ISO 7000:2019 Reference #3082Graphical symbols for use on equipment – Registered symbols5-12412/23/2019ManufacturerIndicates the medical device manufacturer.
EN ISO 15223-1:2021 # 5.1.Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements5-13412/20/2021Authorized European representativeIndicates the Authorized representative in the European Community/European Union.
EN ISO 15223-1:2021 Reference # 5.7.10Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements5-13412/20/2021Unique Device IdentifierIndicates a carrier that contains unique device identifier information.
ISO 15223-1, Clause 5.1.10Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements5-13412/20/2021Model NumberIndicates the model number or type number of a product.
EN ISO 15223-1:2021 Reference #5.1.6Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements5-13412/20/2021Catalogue NumberIndicates the manufacturer’s catalogue number so that the medical device can be identified
EN ISO 15223-1:2021 Reference #5.7.7Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements5-13412/20/2021Medical DeviceIndicates the item is a medical device
EN ISO 15223-1:2021 Reference #5.1.5Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements5-13412/20/2021Batch CodeIndicates the manufacturer’s batch code so that the batch or lot can be identified
ISO 7000:2019 Reference # 2492Graphical symbols for use on equipment – Registered symbols5-12412/23/2019Batch CodeIndicates the manufacturer’s batch code so that the batch or lot can be identified
EN ISO 15223-1:2021 Reference # 5.1.7Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements5-13412/20/2021Serial Number
Indicates the manufacture’s serial number so a specific medical device can be identified.
ISO 7000:2019 Reference # 2498Graphical symbols for use on equipment – Registered symbols5-12412/23/2019Serial Number
Indicates the manufacture’s serial number so a specific medical device can be identified.
21 CFR 801.15(c)(1)(i)FLabeling-Medical devices; prominence of required label statementsLabeling-Medical devices; prominence of required label statementsN/APrescription onlyRequires prescription in the United States
21 CFR 801.109Labeling-Prescription devicesLabeling-Prescription devicesN/APrescription onlyRequires prescription in the United States
EN ISO 15223-1:2021 Reference #5.1.3Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements5-13412/20/2021Date of manufactureIndicates the date when the medical device was manufactured
ISO 7000:2019 Reference # 2497Graphical symbols for use on equipment – Registered symbols5-12412/23/2019Date of manufactureIndicates the date when the medical device was manufactured
EN ISO 15223-1:2021 Reference #5.1.4Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements5-13412/20/2021Use-by dateIndicates the date after which the medical device is not to be used
ISO 7000:2019 Reference # 2607Graphical symbols for use on equipment – Registered symbols5-12412/23/2019Use-by dateIndicates the date after which the medical device is not to be used
EN ISO 15223-1:2021 Reference #5.2.8Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements5-13412/20/2021Do not use if package is damaged and consult instructions for useIndicates that a medical device that should not be used if the package has been damaged or opened and that the user should consult instructions for use for additional information
ISO 7000:2019 Reference # 2606Graphical symbols for use on equipment – Registered symbols5-12412/23/2019Do not use if package is damaged and consult instructions for useIndicates that a medical device that should not be used if the package has been damaged or opened and that the user should consult instructions for use for additional information
EN ISO 15223-1:2021 Reference #5.2.6Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements5-13412/20/2021Do not resterilizeIndicates a medical device that is not to be resterlized
ISO 7000:2019 Reference # 2608Graphical symbols for use on equipment – Registered symbols5-12412/23/2019Do not resterilizeIndicates a medical device that is not to be resterlized
EN ISO 15223-1:2021 Reference #5.4.2Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements5-13412/20/2021Do not re-useIndicates a medical device that is intended for one single use only
ISO 7000:2019 Reference # 1051Graphical symbols for use on equipment – Registered symbols5-12412/23/2019Do not re-useIndicates a medical device that is intended for one single use only
ISO 7000:2019Reference #3079
Graphical symbols for use on equipment
5-12412/23/2019Open here
To identify the location where the package can be opened and to indicate the method of opening it.
EN ISO 15223-1:2021 Reference #5.4.3Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements5-13412/20/2021Consult instructions for use or consult electronic instructions for useIndicates the need for the user to consult the instructions for use
ISO 7000:2019 Reference # 1641Graphical symbols for use on equipment – Registered symbols5-12412/23/2019Consult instructions for use or consult electronic instructions for useIndicates the need for the user to consult the instructions for use
EN ISO 15223-1:2021 Reference #5.2.3Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements5-13412/20/2021Sterilized using ethylene oxideIndicates a medical device that has been sterilized using ethylene oxide
ISO 7000:2019 Reference # 2501Graphical symbols for use on equipment – Registered symbols5-12412/23/2019Sterilized using ethylene oxideIndicates a medical device that has been sterilized using ethylene oxide
EN ISO 15223-1:2021 Reference #5.2.11Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements5-13412/20/2021Single sterile barrier systemIndicates a sterile barrier system
ISO 7000:2019 Reference # 3707Graphical symbols for use on equipment – Registered symbols5-12412/23/2019Single sterile barrier systemIndicates a sterile barrier system
EN ISO 15223-1:2021 Reference #5.6.4Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements5-13412/20/2021Drops per MilliliterIndicates the number of drops per milliliter
ISO 7000:2019 Reference # 2726Graphical symbols for use on equipment – Registered symbols5-12412/23/2019Drops per MilliliterIndicates the number of drops per milliliter
EN ISO 15223-1:2021 Reference #5.4.7Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements5-13412/20/2021Contains a medicinal substanceIndicates a medical device that contains or incorporates a medicinal substance.
ISO 7000:2019 Reference # 3702Graphical symbols for use on equipment – Registered symbols5-12412/23/2019Contains a medicinal substanceIndicates a medical device that contains or incorporates a medicinal substance.
EN ISO 15223-1:2021 Reference #5.4.4Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements5-13412/20/2021CautionIndicates 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
ISO 7000:2019 Reference # 0434AGraphical symbols for use on equipment – Registered symbols5-12412/23/2019CautionIndicates 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
MDR 2017/745, Article 20REGULATION (EU) 2017/745 MDRN/AN/ACE marking, If products are certified by an NB, the NB number is placed next to or below the CE mark symbol.Signifies European technical conformity
EN ISO 15223-1:2021 Reference #5.7.8Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements5-13412/20/2021TranslationIndicates that the original medical device information has undergone a translation which supplements or replaces the original information
ISO 7000:2019 Reference # 3728Graphical symbols for use on equipment – Registered symbols5-12412/23/2019TranslationIndicates that the original medical device information has undergone a translation which supplements or replaces the original information
EN ISO 15223-1:2021 Reference #5.7.4Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements5-13412/20/2021Patient information websiteIndicates a website where a patient can obtain additional information on the medical product
ISO 7000:2019 Reference # 3705Graphical symbols for use on equipment – Registered symbols5-12412/23/2019Patient information websiteIndicates a website where a patient can obtain additional information on the medical product
EN ISO 15223-1:2021 Reference #5.3.1Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements5-13412/20/2021Fragile, handle with careIndicates a medical device that can be broken or damaged if not handled carefully
ISO 7000:2019 Reference # 0621Graphical symbols for use on equipment – Registered symbols5-12412/23/2019Fragile, handle with careIndicates a medical device that can be broken or damaged if not handled carefully
EN ISO 15223-1:2021 Reference #5.3.2Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements5-13412/20/2021Keep away from sunlightIndicates a medical device that needs protection from light sources
ISO 7000:2019 Reference # 0624Graphical symbols for use on equipment – Registered symbols5-12412/23/2019Keep away from sunlightIndicates a medical device that needs protection from light sources
EN ISO 15223-1:2021 Reference #5.3.4Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements5-13412/20/2021Keep dryIndicates a medical device that needs to be protected from moisture
ISO 7000:2019 Reference # 0626Graphical symbols for use on equipment – Registered symbols5-12412/23/2019Keep dryIndicates a medical device that needs to be protected from moisture
EN ISO 15223-1:2021 Reference #5.3.7Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements5-13412/20/2021Temperature limitIndicates the temperature limits to which the medical device can be safely exposed
ISO 7000:2019 Reference # 0632Graphical symbols for use on equipment – Registered symbols5-12412/23/2019Temperature limitIndicates the temperature limits to which the medical device can be safely exposed
EN ISO 15223-1:2021 Reference #5.3.8Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements5-13412/20/2021Humidity limitationIndicates the range of humidity to which the medical device can be safely exposed
ISO 7000:2019 Reference # 2620Graphical symbols for use on equipment – Registered symbols5-12412/23/2019Humidity limitationIndicates the range of humidity to which the medical device can be safely exposed
EN ISO 15223-1:2021 Reference #5.3.9Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements5-13412/20/2021Atmospheric pressure limitationIndicates the range of atmospheric pressure to which the medical device can be safely exposed
ISO 7000:2019 Reference # 2621Graphical symbols for use on equipment – Registered symbols5-12412/23/2019Atmospheric pressure limitationIndicates the range of atmospheric pressure to which the medical device can be safely exposed
EN ISO 15223-1:2021 Reference #5.1.9Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements5-13412/20/2021DistributorIndicates the entity distributing the medical device into the locale
ISO 7000:2019 Reference # 3724Graphical symbols for use on equipment – Registered symbols5-12412/23/2019DistributorIndicates the entity distributing the medical device into the locale
EN ISO 15223-1:2021 Reference #5.1.11Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements5-13412/20/2021Country of manufactureTo identify the country of manufacture of products