Essential Medical Device Symbols for Labeling: A Comprehensive Guide as per ISO 15223-1
Medical Device Symbols are essential for conveying vital information on medical devices. When deemed appropriate, symbols can be marked on the device, packaging, or associated documentation. Manufacturers must ensure the symbols are of a suitable size for clear legibility. Before implementing symbols, manufacturers should conduct a risk assessment to ensure they pose no unacceptable risks.
Introduction
When it comes to medical devices, clear and easily understandable labeling is crucial for both healthcare professionals and patients. In addition to text, using symbols on medical device labels can enhance comprehension and ensure vital information is conveyed effectively.
In this blog post, we will explore the importance of Medical Device Symbols for Labeling and highlight some essential symbols commonly used in the industry.
Commonly Used ISO Medical Device Symbols for Labeling
As per the ISO 15223-1 standard, Medical Device Symbols are classified into seven groups.
- Manufacturing: Symbols related to the manufacturing process of the device.
- Storage: Symbols indicating specific storage conditions for the device.
- Safe Use: Symbols providing information on the safe and proper use of the device.
- Sterility: Symbols indicating the sterile condition of the device or instructions related to sterility.
- IVD Specific: Symbols specific to in vitro diagnostic devices.
- Transfusion/Infusion: Symbols related to transfusion or infusion procedures.
- Others: Symbols that do not fit into the above categories but are relevant to medical device labeling.
Medical Device Symbols
Manufacturer
This Medical Device Symbols must be displayed alongside the name and address of the manufacturer, positioned next to the symbol.
Date of manufacture
This Medical Device Symbols shall be accompanied by a date to indicate the date of manufacture.
Use-by date
This Medical Device Symbols shall be accompanied by a date to indicate that the medical device should not be used after the end of the year, month or day shown.
Importer
This Medical Device Symbols shall be accompanied by the name and address of the importing entity, adjacent to the symbol
Distributor
This Medical Device Symbols shall be accompanied by the name and address of the distributing entity adjacent to the symbol
Sterile
Indicates a medical device that has been subjected to a sterilization process.
Sterilized using aseptic processing techniques
Indicates a medical device that has been manufactured using accepted aseptic techniques.
Sterilized using steam or dry heat
Indicates a medical device that has been sterilized using steam or dry heat.
Do not resterilize
Indicates a medical device that is not to be resterilized.
Sterile fluid path
Indicates the presence of a sterile fluid path within the medical device in cases when other parts of the medical device, including the exterior, might not be supplied sterile.
Single sterile barrier system with protective packaging inside
Indicates a single sterile barrier system with protective packaging inside
Single sterile barrier system with protective packaging outside
Indicates a single sterile barrier system with protective packaging outside
Protect from heat and radioactive sources
Indicates a medical device that needs protection from heat and radioactive sources.
Keep dry
Indicates a medical device that needs to be protected from moisture.
Temperature limit
Indicates the temperature limits to which the medical device can be safely exposed.
Humidity limitation
Indicates the range of humidity to which the medical device can be safely exposed.
Atmospheric pressure limitation
Indicates the range of atmospheric pressure to which the medical device can be safely exposed.
Caution
To indicate that caution is necessary when operating the device or control close to where the symbol is placed, or to indicate that the current situation needs operator awareness or operator action in order to avoid undesirable consequences.
Contains a medicinal substance
Indicates a medical device that contains or incorporates a medicinal substance
Contains biological material of animal origin
Indicates a medical device that contains biological tissue, cells, or their derivatives, of animal origin
Contains biological material of human origin
Indicates a medical device that contains biological tissue, cells, or their derivatives, of human origin
Single patient multiple use
Indicates a medical device that may be used multiple times (multiple procedures) on a single patient
Control
Indicates a control material that is intended to verify the performance of another medical device.
Negative control
Indicates a control material that is intended to verify the results in the expected negative range.
Positive control
Indicates a control material that is intended to verify the results in the expected positive range.
Fluid path
Indicates the presence of a fluid path.
Non-pyrogenic
Indicates a medical device that is non-pyrogenic.
Drops per millilitre
Indicates the number of drops per millilitre.
Patient number
Indicates a unique number associated with an individual patient.
Patient name
Indicates the name of the patient
Patient identification
Indicates the identification data of the patient
Date
To identify the date that information was entered or a medical procedure took place
Repackaging
To identify that a modification to the original medical device packaging configuration has occurred
Unique Device Identifier
Indicates a carrier that contains Unique Device Identifier information
Authorized representative in the European Union
This Medical Device symbol is accompanied by the name and address of the authorized representative.
Batch code
This Medical Device Symbols shall be accompanied by the manufacturer’s batch code.
Catalogue Number
The manufacturer’s catalogue number shall be adjacent to the symbol.
Serial number
This symbol shall be accompanied by the manufacturer’s serial number.
Model number
This Medical Device Symbols shall be accompanied by the model number of the product, adjacent to the symbol.
Country of manufacture
The “CC” shall be replaced by either the two or three letter country code. The date of manufacture may be added adjacent to this Medical Device Symbol.
Sterilized using ethylene oxide
Indicates a medical device that has been sterilized using ethylene oxide.
Sterilized using irradiation
Indicates a medical device that has been sterilized using irradiation.
Non-sterile
Indicates a medical device that has not been subjected to a sterilization process.
Do not use if package is damaged and consult instructions for use
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 for additional information.
Single sterile barrier system
Indicates a single sterile barrier system
Double sterile barrier system
Indicates two sterile barrier systems
Fragile, handle with care
Indicates a medical device that can be broken or damaged if not handled carefully.
Keep away from sunlight
Indicates a medical device that needs protection from light sources
Lower limit of temperature
Indicates the lower limit of temperature to which the medical device can be safely exposed.
Upper limit of temperature
Indicates the upper limit of temperature to which the medical device can be safely exposed.
Biological risks
Indicates that there are potential biological risks associated with the medical device.
Do not re-use
Indicates a medical device that is intended for one single use only.
Consult instructions for use or consult electronic instructions for use
Indicates the need for the user to consult the instructions for use.
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.
Contains human blood or plasma derivatives
Indicates a medical device that contains or incorporates human blood or plasma derivatives.
Contains hazardous substances
Indicates a medical device that contains substances that can be carcinogenic, mutagenic, reprotoxic (CMR), or substances with endocrine disrupting properties
Contains nano materials
Indicates a medical device that contains nano materials
In vitro diagnostic medical device
Indicates a medical device that is intended to be used as an in vitro diagnostic medical device
Contains sufficient for
Indicates the total number of IVD tests that can be performed with the IVD medical device.
For IVD performance evaluation only
Indicates an IVD medical device that is intended to be used only for evaluating its performance characteristics before it is placed on the market for medical diagnostic use.
Sampling site
Indicates a medical device or blood processing application that includes a system dedicated to the collection of samples of a given substance stored in the medical device or blood container.
Liquid filter with pore size
Indicates an infusion or transfusion system of the medical device that contains a filter of a particular nominal pore size.
One-way valve
Indicates a medical device with a valve that allows flow in only one direction.
Patient information website
Indicates a website where a patient can obtain additional information on the medical product
Health care centre or doctor
To indicate the address of the health care centre or doctor where medical information about the patient may be found
Translation
To identify that the original medical device information has undergone a translation which supplements or replaces the original information
Medical device
Indicates the item is a medical device
Compliance with International Standards
Medical device manufacturers must adhere to international labeling standards, such as ISO 15223-1, which provides guidelines for using Medical Device Symbols. Compliance with these standards ensures consistency and clarity across different markets and improves user confidence in the product.
Example of Medical Device Label with Symbols
Conclusion
Incorporating symbols into medical device labeling is a powerful way to improve user understanding and promote safety. Each symbol plays a crucial role in guiding users and preventing errors. By following international standards and conducting risk analysis, medical device manufacturers can create labels that are informative, universally recognizable, and ultimately contribute to better patient outcomes.
Remember, using clear and concise symbols on medical device labels not only enhances usability but also demonstrates the manufacturer’s commitment to user safety and satisfaction.
All medical device manufacturers need to make sure that the products are correctly labeled with all the essential symbols. This is essential for patient safety and compliance with regulatory requirements. In this blog, we provide a comprehensive guide to the essential symbols that you need to include on your medical device labels.
If you need assistance developing medical device labels or complying with EU MDR, FDA, or CDSCO labeling requirements, please contact MedDev Experts. You may email us at [email protected] or WhatsApp us at +91-78079-14459.
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This post has been incredibly helpful in clarifying a lot of the questions I had. Thank you for providing such clear and concise information.