| SYMBOL | TITLE | EXPLANATORY TEXT | REFERENCE |
|---|---|---|---|
| ISO 15223-1 Symbols: Medical devices – Symbols to be used with information to be supplied by the manufacturer | |||
|
Manufacturer | Indicates the medical device manufacturer. | 5.1.1 |
|
Authorized representative | Indicates the authorized representative in the identified country or jurisdiction. | 5.1.2 (Amd: 2025) |
|
Authorized representative in the European Community/ European Union | Indicates the authorized representative in the European Community/European Union | 5.1.2 |
|
Authorized representative in Switzerland | Indicates the authorized representative in Switzerland. | 5.1.2; modified per ISO 20417, clause 6.1.2 |
|
Date of manufacture | Indicates the date when the medical device was manufactured. | 5.1.3 |
|
Use-by date | Indicates the date after which the medical device is not to be used. | 5.1.4 |
|
Batch code | Indicates the manufacturer’s batch code so that the batch or lot can be identified. | 5.1.5 |
|
Catalogue number | Indicates the manufacturer’s catalogue number so that the medical device can be identified. | 5.1.6 |
|
Importer | Indicates the entity importing the medical device into the locale. | 5.1.8 |
|
Country of manufacture | To identify the country of manufacture of products. | 5.1.11 |
|
Sterilized using ethylene oxide | Indicates a medical device that has been sterilized using ethylene oxide. | 5.2.3 |
|
Do not resterilize | Indicates a medical device that is not to be resterilized. | 5.2.6 |
|
Do not use if package is damaged; consult IFU | Indicates a medical device that should not be used if the package has been damaged or opened and that the user should consult the instructions for use. | 5.2.8 |
|
Single sterile barrier system | Indicates a single sterile barrier system. | 5.2.11 |
|
Single sterile barrier system with protective packaging outside | Indicates a single sterile barrier system with protective packaging outside. | 5.2.14 |
|
Keep away from sunlight | Indicates a medical device that needs protection from light sources. | 5.3.2 |
|
Keep dry | Indicates a medical device that needs to be protected from moisture. | 5.3.4 |
|
Do not re-use | Indicates a medical device that is intended for one use only. | 5.4.2 |
|
Consult instructions for use / electronic IFU | Indicates the need for the user to consult the instructions for use. | 5.4.3 |
|
Caution | Indicates that caution is necessary or operator awareness/action is needed to avoid undesirable consequences. | 5.4.4 |
|
Non-pyrogenic | Indicates a medical device that is non-pyrogenic. | 5.6.3 |
|
Medical devices | Indicates the item is a medical device. | 5.7.7 |
|
Patient identification | Indicates the identification data of the patient. | 5.7.3 |
|
Patient information website | Indicates a website where a patient can obtain additional information on the medical product. | 5.7.4 |
|
Health care center or doctor | Indicates the address of the health care center or doctor where medical information about the patient may be found. | 5.7.5 |
|
Date | Indicates the date that information was entered or a medical procedure took place. | 5.7.6 |
|
Unique Device Identifier | Indicates a carrier that contains unique device identifier information. | 5.7.10 |
| ASTM F2503: The labeling of devices as MR Safe, MR Conditional, and MT Unsafe | |||
|
Magnetic Resonance (MR) Unsafe | An item which poses unacceptable risks to the patient, medical staff, or other persons within the MR environment. | ASTM F2503 |
|
Magnetic Resonance (MR) Conditional | An item demonstrates no hazard in the MR environment, but only when prescribed conditions for safe use are adhered | ASTM F2503 |
| US Code of Federal Regulations, Title 21, Part 801.109(b)(1): Prescription devices | |||
|
Prescription device | Caution: United States Federal Law restricts this device to sale by or on the order of a physician. | 21 CFR 801.109(b)(1) |
| Symbols for Certification and Compliance | |||
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|
European Conformity | Indicates conformity to Regulation (EU) 2017/745 and designates that the product labeled is authorized for sale in European Union countries. Symbol may be accompanied by Notified Body identification number. | — |
| Symbols Not from Standards | |||
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Effective Length | Effective length of the medical device. | — |
|
Size | Overall size of the medical device: S, M, L, XL. | — |
|
Catheter / delivery catheter size | French size (Fr) of the catheter or delivery catheter. | — |
|
Sheath / catheter size and length | French size and effective length of sheath or catheter. | — |
|
Vessel Diameter | Target vessel diameter for device compatibility. | — |
|
Coring Element Diameter | Diameter of coring element. | — |
|
French size & Coring Element Diameter | French size of the catheter / delivery catheter and diameter of coring element. | — |
|
French size & metric diameter | French size of the catheter / delivery catheter and metric diameter. | — |
|
French size & vessel diameter | French size of the catheter / delivery catheter and vessel diameter. | — |
|
French size & syringe capacity | French size of catheter / capacity of the syringe. | — |
|
Recommended Guidewire Size | Indicates the recommended guidewire size needed to use the medical device. | — |
Or
|
Contents and/or Quantity | Contents and/or quantity of medical device. | — |
This Symbols Glossary has been compiled from publicly available third-party sources and is provided solely as a courtesy for general reference and convenience. The information has not been independently verified, and no representations or warranties, express or implied, are made regarding its accuracy, completeness, reliability, or currency.
This glossary should not be relied upon as an authoritative source or as the basis for any decision or action. Users are responsible for independently verifying any information contained herein with the applicable original sources before relying on it.