ISO
Symbols Glossary
Last Updated: February 3, 2025
The following is a glossary of images that may be seen on Apiject packaging or related materials.
Symbol | Standard and Reference # | Standard Title | FDA Recognition # | Date of Entry | Title | Description |
![]() | EN ISO 15223-1:2021 Reference #5.1.1 | Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements | 5-134 | 12/20/2021 | Manufacturer | Indicates the medical device manufacturer. |
![]() | ISO 7000:2019 Reference #3082 | Graphical symbols for use on equipment – Registered symbols | 5-124 | 12/23/2019 | Manufacturer | Indicates 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 requirements | 5-134 | 12/20/2021 | Authorized European representative | Indicates the Authorized representative in the European Community/European Union. |
![]() | EN ISO 15223-1:2021 Reference # 5.7.10 | Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements | 5-134 | 12/20/2021 | Unique Device Identifier | Indicates a carrier that contains unique device identifier information. |
![]() | ISO 15223-1, Clause 5.1.10 | Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements | 5-134 | 12/20/2021 | Model Number | Indicates the model number or type number of a product. |
![]() | EN ISO 15223-1:2021 Reference #5.1.6 | Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements | 5-134 | 12/20/2021 | Catalogue Number | Indicates the manufacturer’s catalogue number so that the medical device can be identified |
![]() | EN ISO 15223-1:2021 Reference #5.7.7 | Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements | 5-134 | 12/20/2021 | Medical Device | Indicates the item is a medical device |
![]() | EN ISO 15223-1:2021 Reference #5.1.5 | Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements | 5-134 | 12/20/2021 | Batch Code | Indicates the manufacturer’s batch code so that the batch or lot can be identified |
![]() | ISO 7000:2019 Reference # 2492 | Graphical symbols for use on equipment – Registered symbols | 5-124 | 12/23/2019 | Batch Code | Indicates the manufacturer’s batch code so that the batch or lot can be identified |
![]() | EN ISO 15223-1:2021 Reference # 5.1.7 | Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements | 5-134 | 12/20/2021 | Serial Number | Indicates the manufacture’s serial number so a specific medical device can be identified. |
![]() | ISO 7000:2019 Reference # 2498 | Graphical symbols for use on equipment – Registered symbols | 5-124 | 12/23/2019 | Serial Number | Indicates the manufacture’s serial number so a specific medical device can be identified. |
![]() | 21 CFR 801.15(c)(1)(i)F | Labeling-Medical devices; prominence of required label statements | Labeling-Medical devices; prominence of required label statements | N/A | Prescription only | Requires prescription in the United States |
![]() | 21 CFR 801.109 | Labeling-Prescription devices | Labeling-Prescription devices | N/A | Prescription only | Requires prescription in the United States |
![]() | EN ISO 15223-1:2021 Reference #5.1.3 | Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements | 5-134 | 12/20/2021 | Date of manufacture | Indicates the date when the medical device was manufactured |
![]() | ISO 7000:2019 Reference # 2497 | Graphical symbols for use on equipment – Registered symbols | 5-124 | 12/23/2019 | Date of manufacture | Indicates the date when the medical device was manufactured |
![]() | EN ISO 15223-1:2021 Reference #5.1.4 | Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements | 5-134 | 12/20/2021 | Use-by date | Indicates the date after which the medical device is not to be used |
![]() | ISO 7000:2019 Reference # 2607 | Graphical symbols for use on equipment – Registered symbols | 5-124 | 12/23/2019 | Use-by date | Indicates the date after which the medical device is not to be used |
![]() | EN ISO 15223-1:2021 Reference #5.2.8 | Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements | 5-134 | 12/20/2021 | 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 instructions for use for additional information |
![]() | ISO 7000:2019 Reference # 2606 | Graphical symbols for use on equipment – Registered symbols | 5-124 | 12/23/2019 | 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 instructions for use for additional information |
![]() | EN ISO 15223-1:2021 Reference #5.2.6 | Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements | 5-134 | 12/20/2021 | Do not resterilize | Indicates a medical device that is not to be resterlized |
![]() | ISO 7000:2019 Reference # 2608 | Graphical symbols for use on equipment – Registered symbols | 5-124 | 12/23/2019 | Do not resterilize | Indicates a medical device that is not to be resterlized |
![]() | EN ISO 15223-1:2021 Reference #5.4.2 | Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements | 5-134 | 12/20/2021 | Do not re-use | Indicates a medical device that is intended for one single use only |
![]() | ISO 7000:2019 Reference # 1051 | Graphical symbols for use on equipment – Registered symbols | 5-124 | 12/23/2019 | Do not re-use | Indicates a medical device that is intended for one single use only |
![]() | ISO 7000:2019 | Reference #3079 Graphical symbols for use on equipment | 5-124 | 12/23/2019 | Open 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 #5.4.3 | Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements | 5-134 | 12/20/2021 | Consult instructions for use or consult electronic instructions for use | Indicates the need for the user to consult the instructions for use |
![]() | ISO 7000:2019 Reference # 1641 | Graphical symbols for use on equipment – Registered symbols | 5-124 | 12/23/2019 | Consult instructions for use or consult electronic instructions for use | Indicates the need for the user to consult the instructions for use |
![]() | EN ISO 15223-1:2021 Reference #5.2.3 | Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements | 5-134 | 12/20/2021 | Sterilized using ethylene oxide | Indicates a medical device that has been sterilized using ethylene oxide |
![]() | ISO 7000:2019 Reference # 2501 | Graphical symbols for use on equipment – Registered symbols | 5-124 | 12/23/2019 | Sterilized using ethylene oxide | Indicates a medical device that has been sterilized using ethylene oxide |
![]() | EN ISO 15223-1:2021 Reference #5.2.11 | Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements | 5-134 | 12/20/2021 | Single sterile barrier system | Indicates a sterile barrier system |
![]() | ISO 7000:2019 Reference # 3707 | Graphical symbols for use on equipment – Registered symbols | 5-124 | 12/23/2019 | Single sterile barrier system | Indicates a sterile barrier system |
![]() | EN ISO 15223-1:2021 Reference #5.6.4 | Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements | 5-134 | 12/20/2021 | Drops per Milliliter | Indicates the number of drops per milliliter |
![]() | ISO 7000:2019 Reference # 2726 | Graphical symbols for use on equipment – Registered symbols | 5-124 | 12/23/2019 | Drops per Milliliter | Indicates the number of drops per milliliter |
![]() | EN ISO 15223-1:2021 Reference #5.4.7 | Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements | 5-134 | 12/20/2021 | Contains a medicinal substance | Indicates a medical device that contains or incorporates a medicinal substance. |
![]() | ISO 7000:2019 Reference # 3702 | Graphical symbols for use on equipment – Registered symbols | 5-124 | 12/23/2019 | Contains a medicinal substance | Indicates a medical device that contains or incorporates a medicinal substance. |
![]() | EN ISO 15223-1:2021 Reference #5.4.4 | Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements | 5-134 | 12/20/2021 | 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 |
![]() | ISO 7000:2019 Reference # 0434A | Graphical symbols for use on equipment – Registered symbols | 5-124 | 12/23/2019 | 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 |
![]() | MDR 2017/745, Article 20 | REGULATION (EU) 2017/745 MDR | N/A | N/A | CE 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 #5.7.8 | Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements | 5-134 | 12/20/2021 | Translation | Indicates that the original medical device information has undergone a translation which supplements or replaces the original information |
![]() | ISO 7000:2019 Reference # 3728 | Graphical symbols for use on equipment – Registered symbols | 5-124 | 12/23/2019 | Translation | Indicates that the original medical device information has undergone a translation which supplements or replaces the original information |
![]() | EN ISO 15223-1:2021 Reference #5.7.4 | Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements | 5-134 | 12/20/2021 | Patient information website | Indicates a website where a patient can obtain additional information on the medical product |
![]() | ISO 7000:2019 Reference # 3705 | Graphical symbols for use on equipment – Registered symbols | 5-124 | 12/23/2019 | Patient information website | Indicates a website where a patient can obtain additional information on the medical product |
![]() | EN ISO 15223-1:2021 Reference #5.3.1 | Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements | 5-134 | 12/20/2021 | Fragile, handle with care | Indicates a medical device that can be broken or damaged if not handled carefully |
![]() | ISO 7000:2019 Reference # 0621 | Graphical symbols for use on equipment – Registered symbols | 5-124 | 12/23/2019 | Fragile, handle with care | Indicates a medical device that can be broken or damaged if not handled carefully |
![]() | EN ISO 15223-1:2021 Reference #5.3.2 | Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements | 5-134 | 12/20/2021 | Keep away from sunlight | Indicates a medical device that needs protection from light sources |
![]() | ISO 7000:2019 Reference # 0624 | Graphical symbols for use on equipment – Registered symbols | 5-124 | 12/23/2019 | Keep away from sunlight | Indicates a medical device that needs protection from light sources |
![]() | EN ISO 15223-1:2021 Reference #5.3.4 | Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements | 5-134 | 12/20/2021 | Keep dry | Indicates a medical device that needs to be protected from moisture |
![]() | ISO 7000:2019 Reference # 0626 | Graphical symbols for use on equipment – Registered symbols | 5-124 | 12/23/2019 | Keep dry | Indicates a medical device that needs to be protected from moisture |
![]() | EN ISO 15223-1:2021 Reference #5.3.7 | Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements | 5-134 | 12/20/2021 | Temperature limit | Indicates the temperature limits to which the medical device can be safely exposed |
![]() | ISO 7000:2019 Reference # 0632 | Graphical symbols for use on equipment – Registered symbols | 5-124 | 12/23/2019 | Temperature limit | Indicates the temperature limits to which the medical device can be safely exposed |
![]() | EN ISO 15223-1:2021 Reference #5.3.8 | Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements | 5-134 | 12/20/2021 | Humidity limitation | Indicates the range of humidity to which the medical device can be safely exposed |
![]() | ISO 7000:2019 Reference # 2620 | Graphical symbols for use on equipment – Registered symbols | 5-124 | 12/23/2019 | Humidity limitation | Indicates the range of humidity to which the medical device can be safely exposed |
![]() | EN ISO 15223-1:2021 Reference #5.3.9 | Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements | 5-134 | 12/20/2021 | Atmospheric pressure limitation | Indicates the range of atmospheric pressure to which the medical device can be safely exposed |
![]() | ISO 7000:2019 Reference # 2621 | Graphical symbols for use on equipment – Registered symbols | 5-124 | 12/23/2019 | Atmospheric pressure limitation | Indicates the range of atmospheric pressure to which the medical device can be safely exposed |
![]() | EN ISO 15223-1:2021 Reference #5.1.9 | Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements | 5-134 | 12/20/2021 | Distributor | Indicates the entity distributing the medical device into the locale |
![]() | ISO 7000:2019 Reference # 3724 | Graphical symbols for use on equipment – Registered symbols | 5-124 | 12/23/2019 | Distributor | Indicates the entity distributing the medical device into the locale |
![]() | EN ISO 15223-1:2021 Reference #5.1.11 | Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements | 5-134 | 12/20/2021 | Country of manufacture | To identify the country of manufacture of products |
Additional Notes
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