In a global marketplace with more than 7,100 spoken languages, manufacturers need to consider the local language and culture when developing medical device product labels. How does one make it possible to reach out to a diverse group of people?
One of the time-tested ways is the use of medical device symbols. It can convey a significant amount of information in a small space. Although it is optional, using symbols on the labeling of medical devices is strongly advised. It offers benefits to both users and manufacturers, such as:
- Along with being easier to read and comprehend, symbols convey information with more clarity to the users, with fewer mistakes on the users’ end
- Helps in the consistent portrayal of information even when consumers draw their supplies from several sources
- It helps save space on the labels. Translated texts take twice the space to convey the same information
- Symbols are universally recognized, so their use does not necessitate translation
Device manufacturers have three options:
- They can choose not to use symbols
- They can use symbols with adjacent explanatory text (or)
- Stand-alone symbols are the standard symbols that are regulated by ISO 15223 and can be universally used
DYK? The International Organization for Standardization ISO 15223-1 version updated in 2016 is no longer valid. It is replaced by a new 2021 version, ISO 15223-1:2021. However, there is no set deadline for manufacturers to implement the update.
Commonly Used Symbols on Medical Devices
General Symbols: These symbols accompany the labels and provide the end user with general details about the device and provide its unique identification number.
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Identify the product as a medical device |
The manufacturer’s catalog number helps identify the device |
Indicates a carrier that contains unique device-identified information |
Translation symbol” to be added when the manufacturers outsource the IFU translations |
Economic Operators
The EU Medical Device Regulation (EU MDR) and In-Vitro Diagnostic Medical Device Regulation (EU IVDR) require the details of Economic Operators (EOs) to be included on the device label. The manufacturer, European Authorized Representative (EAR), importer, and distributor is considered Economic Operators (EOs), and the respective symbols can be used.
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Manufacturer: The name and address of the manufacturer |
“Importer and distributor”: Name and address of the importing or distributing entity |
“Local Representative in European Union”: Name and address of the EAR* |
*The immediate container does not need an EAR address unless it is the outer container.
Manufacturing Symbols
These symbols provide the manufacturing details of a given device.
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Manufacturing Batch code of the device |
The catalog number traces the device to the manufacturer’s catalog to identify the device |
The manufacturer’s Serial Number shall be included |
“Date of manufacture": Manufacturing date in YYYY-MM-DD or DD-MM-YYYY format |
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Storage Symbols
Storage instruction is very important for medical device users. The storage of the device determines its workability and longevity of the device. Factors like temperature, humidity, etc., can impact on the device.
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The upper and lower limits of the temperature |
Keep away from sunlight |
Keep away from water |
The device is “fragile” and to be handled with care |
The packaging and device can be recycled |
Safety for Use Symbols
Inappropriate use of some devices can pose a risk to the end user. These symbols are used to warn the users before use and reduce risk.
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Consult instruction for use”: Advice the users to read through the IFU before use |
“Do not reuse,” “single-use,” or “use only once” symbol |
“Contains latex” warn the users that are allergic to latex to use it with caution |
“Caution, consult accompanying documents” or “Attention, see instructions for use.” |
“Contains hazardous substance” |
Sterility Symbols
These symbols communicate information about the sterility of the devices. Whether it is sterilized or not, whether it can be resterilized or not.
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Non-sterile device and the procedure needs to be carried out before use |
“Do not resterilize”: The device should not be resterilized |
The device has been sterilized |
“Double sterile barrier system” Minimizes the risk of asepsis. An additional dotted line is added when additional packaging is placed |
Medical devices are sterilized in a variety of ways, including using moist heat (steam), dry heat, radiation, ethylene oxide gas, vaporized hydrogen peroxide, and other sterilization methods (for example, chlorine dioxide gas, vaporized peracetic acid, and nitrogen dioxide). To provide information to the consumers on the type of sterilization method used, symbols are placed next to the “sterile” symbol.
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Sterile medical devices are processed using aseptic techniques |
Sterilization using ethylene oxide |
Sterilization using irradiation |
Sterilization using vaporized hydrogen peroxide |
Sterilization using steam or dry heat |
In Vitro Diagnostic (IVD) Device Symbols
IVDs are those reagents, instruments, and systems intended for use in diagnosing disease or other conditions, including determining the state of health to cure, mitigate, treat, or prevent disease or its sequelae.
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In Vitro Diagnostic Medical device: Identify IVD and not indicate that the device is for “In vitro use” |
Control Symbol: the presence of a control material that verifies the performance character of another medical device |
Medical device labeling is a critical part of the production process for manufacturers. Devices cannot go to market without the required labels. Symbols form a universal language on the labels. ISO decides the requirement of these labels and the respective Regulatory Authorities implements the same.
To know more about symbols used for medical devices, contact Freyrtoday!
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