| SYMBOL | TITLE | EXPLANATORY TEXT | REFERENCE |
|---|---|---|---|
| ISO 15223-1 Symbols | |||
|
Manufacturer | Indicates the medical device manufacturer. | 5.1.1 |
|
Authorized representative | Indicates the authorized representative in the identified country or jurisdiction. | 5.1.2 |
|
Authorized representative for Switzerland | Indicates the authorized representative in Switzerland. | 5.1.2; ISO 20417 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 (MR Safety) | |||
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|
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 |
| 21 CFR 801.109(b)(1) (Prescription Device) | |||
|
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 | |||
####*
|
European Conformity |
Indicates conformity to Regulation (EU) 2017/745 and that the product is authorized for sale in EU countries.
May be accompanied by Notified Body ID (e.g., 0297 DQS, 0459 GMED).
|
— |
| Symbols Not from Standards (Company-Defined) | |||
|
Size | Overall size of the medical device. | — |
|
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 and 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. | — |
