| Symbol | The title and designation number of the Standard Development Organisation (SDO) – developed standard | The title of the symbol and its reference number | The meaning or explanatory text or the symbol as provided in the standard |
|---|---|---|---|
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ISO 15223-1:2021
Title: Medical Devices – Symbols To Be Used With Medical Device Labels, Labelling, And Information To Be Supplied – Part 1: General Requirements |
5.1.1 Manufacturer | Indicates the medical device manufacturer |
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5.1.2 Authorized representative in the European Community/European Union | Indicates the authorized representative in the European Community/European Union | |
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5.1.3 Date of manufacture | Indicates the date when the medical device was manufactured | |
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5.1.4 Use by date | Indicates the date after which the medical device is not to be used | |
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5.1.5 Batch code | Indicates the manufacturers batch code so that the batch or lot can be identified | |
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5.1.6 Catalogue number | Indicates the manufacturer’s catalogue code so that the medical device can be identified | |
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5.1.8 Importer | Indicates the entity importing the medical device into the locale | |
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5.1.9 Distributor | Indicates the entity distributing the medical device into the locale | |
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5.2.3 Sterilized using ethylene oxide | Indicates a medical device that has been sterilized using ethylene oxide | |
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5.2.4 Sterilized using irradiation | Indicates a medical device that has been sterilized using irradiation | |
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5.2.5 Sterilized using steam or dry heat | Indicates a medical device that has been sterilized using steam or dry heat | |
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5.2.6 Do not resterilize | Indicates a medical device that is not to be resterilized | |
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5.2.8 Do not use if package is damaged | Indicates a medical device that should not be used if the package has been damaged or opened | |
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5.2.11 Single Sterile barrier system | Indicates a single sterile barrier system | |
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5.2.12 Double sterile barrier system | Indicates two sterile barrier systems | |
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5.2.13 Single sterile barrier system with protective packaging inside | Indicates a single sterile barrier system with protective packaging inside | |
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5.3.1 Fragile, handle with care | Indicates a medical device that can be broken or damaged if not handled carefully | |
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5.3.2 Keep away from sunlight | Indicates a medical device that needs protection from light sources | |
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5.3.4 Keep dry | Indicates a medical device that needs to be protected from moisture | |
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5.3.7 Temperature limit | Indicates the temperature limits to which the medical device can be safely exposed | |
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5.4.2 Do not re-use | Indicates a medical device that is intended for one single use only | |
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5.4.3 Consult instructions for use | Indicates the need for the user to consult the instructions for use | |
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5.4.3 Consult electronic instructions for use | Indicates the need for the user to consult the electronic instructions for use | |
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5.4.4 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 | |
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5.4.5 Contains or presence of natural rubber latex | Indicates the presence of dry natural rubber or natural rubber latex as a material of construction within the medical device or the packaging of a medical device | |
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5.4.7 Contains a medicinal substance | Indicates a medical device that contains or incorporates a medicinal substance | |
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5.4.8 Contains biological material of animal origin | Indicates a medical device that contains biological tissue, cells, or their derivatives, of animal origin | |
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5.4.10 Contains hazardous substances | Indicates a medical device that contains substances that can be carcinogenic, mutagenic, reprotoxic (CMR), or substances with endocrine disrupting properties | |
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5.7.3 Patient Identification | Indicates the identification data of the patient | |
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5.7.4 Patient Information website | Indicates a website where a patient can obtain additional information on the medical product | |
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5.7.5 Health care centre or doctor | Indicates the address of the health care centre or doctor where medical information about the patient may be found | |
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5.7.6 Date | Indicates the date that information was entered or a medical procedure took place | |
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5.7.7 Medical device | Indicates the item is a medical device | |
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5.7.8 Translation | Indicates that the original medical device information has undergone a translation which supplements or replaces the original information | |
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5.7.10 Unique device identifier | Indicates a carrier that contains unique device identifier information | |
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ASTM F2503-13 Standard Practice For Marking Medical Devices And Other Items For Safety In The Magnetic Resonance Environment | MR Safe | Magnetic Resonance Safe |
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N/A | European Community/European Union Importer | Indicates the entity importing the medical device into the European Community/European Union |
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Swiss Importer | Indicates the entity importing the medical device into Switzerland | |
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Authorized representative in Switzerland | Indicates the authorized representative in Switzerland |