SYMBOL | STANDARD / SYMBOL REF NO. | TITLE OF SYMBOL | DESCRIPTION OF SYMBOL |
ISO 15223-1, Clause 5.1.1 | Manufacturer | Indicates the medical device manufacturer, as defined in EU Directives 90/385/EEC, 93/42/EEC and 98/79/EC | |
ISO 15223-1, Clause 5.1.2 | Authorized representative in the European Community | Indicates the authorized representative in the European Community | |
ISO 15223-1, Clause 5.1.4 | Use by date | Indicates the date after which the medical device is not to be used | |
ISO 15223-1, Clause 5.1.5 | Batch code | Indicates the manufacturer’s batch code so that the batch or lot can be identified | |
ISO 15223-1, Clause 5.1.6 | Catalog number | Indicates the manufacturer’s catalog number so that the medical device can be identified | |
ISO 15223-1 Clause 5.1.8 | Importer | Indicates the entity importing the medical device into the locale | |
ISO 15223-1, Clause 5.2.3 | Sterilized using ethylene oxide | Indicates a medical device that has been sterilized using ethylene oxide | |
ISO 15223-1, Clause 5.2.8 | Do not use if package is damaged | Indicates a medical device that should not be used if the package has been damage or opened | |
ISO 15223-1, Clause 5.2.14 | Single sterile barrier system with protective packaging inside | Indicates a single sterile barrier system with protective packaging inside | |
ISO 15223-1, Clause 5.3.2 | Keep away from sunlight | Indicates a medical device that needs protection from light sources | |
ISO 15223-1, Clause 5.3.4 | Keep dry | Indicates a medical device that needs to be protected from moisture | |
ISO 15223-1, Clause 5.3.7 | Avoid temperature extremes | Indicates the temperature limits to which the medical device can be safely exposed | |
ISO 15223-1, Clause 5.4.2 | Do not re-use | Indicates a medical device that is intended for one use or for use on a single patient during a single procedure | |
ISO 15223-1, Clause 5.4.3 | Consult Instructions for use | Indicates the need for the user to consult the instructions for use | |
ISO 15223-1, Clause 5.4.4 | Caution | Indicates that the instructions for use contain important cautionary information such as warnings and precautions that cannot, for a variety of reasons, be presented on the medical device itself | |
ISO 15223-1, Clause 5.4.5 and Annex B (Section B2) | Product is not made with natural rubber latex | Indicates that natural rubber latex was not used in the manufacturing of the product, its container, or its packaging | |
ISO 15223-1, Clause 5.6.3 | Non-pyrogenic | Indicates a medical device that is non-pyrogenic | |
21 CFR 801.109 – Medical Device Labeling | The symbol statement for Prescription Device | Indicates that the product is a medical device as defined in 21 CFR 820.3(l) and Federal Law (USA) restricts this device to sale by or on the order of a physician | |
Medical Device Regulation (EU) 2017/745 | European Conformity | Indicates manufacturer declaration that the product complies with the essential requirements of the relevant European health, safety and environmental protection legislation |