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ISO 15223-1, Clause 5.1.1ManufacturerIndicates the medical device manufacturer, as defined in EU Directives 90/385/EEC, 93/42/EEC and 98/79/EC
ISO 15223-1, Clause ​5.1.2Authorized representative
in the European Community
​Indicates the authorized representative in the European Community
ISO 15223-1, Clause ​5.1.4Use by dateIndicates the date after which the medical device is not to be used
ISO 15223-1, Clause ​5.1.5Batch codeIndicates the manufacturer’s batch code so that the batch or lot can be identified
ISO 15223-1, Clause ​5.1.6​Catalog numberIndicates the manufacturer’s catalog number so that the medical device can be identified
ISO 15223-1 Clause 5.1.8ImporterIndicates the entity importing the medical device into the locale
ISO 15223-1, Clause ​5.2.3Sterilized using ethylene
Indicates a medical device that has been sterilized using ethylene oxide
ISO 15223-1, Clause ​5.2.8Do not use if package is
Indicates a medical device that should not be used if the package has been damage or opened
ISO 15223-1, Clause 5.2.14Single sterile barrier system with protective packaging insideIndicates a single sterile barrier system with protective packaging inside
ISO 15223-1, Clause 5.3.2Keep away from sunlightIndicates a medical device that needs protection from light sources
ISO 15223-1, Clause 5.3.4Keep dryIndicates a medical device that needs to be protected from moisture
ISO 15223-1, Clause 5.3.7Avoid temperature extremesIndicates 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 5.4.3Consult Instructions for useIndicates the need for the user to consult the instructions for use
ISO 15223-1, Clause ​5.4.4CautionIndicates 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-pyrogenicIndicates a medical device that is non-pyrogenic
21 CFR 801.109 – Medical Device LabelingThe symbol statement for Prescription DeviceIndicates 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 ConformityIndicates manufacturer declaration that the product complies with the essential requirements of the relevant European health, safety and environmental protection