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Medical Device Symbols
Medical Device Symbols are to be used with medical device labels when supplied. These symbols are a part of the regulatory requirements by leading regulatory bodies including the EU and US FDA. Symbols provide essential information about the device, such as manufacturing date, expiry date, warnings and precautions.
Medical device symbols use standardized icons that are internationally recognized. This gives healthcare professionals, patients, and caregivers a quick and clear way to convey important information, even across language barriers. They are often accompanied by text in the user manual or leaflet.
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Applicable Harmonised Standards
- EN 1041:2008: Information supplied by the manufacturer of medical devices.
- EN 15986:2011: Requirements for labeling of medical devices containing phthalates.
- EN ISO 3826-2:2008: Plastics collapsible containers for human blood and blood components – Part 2: Graphical symbols for use on labels and instruction leaflets.
- EN ISO 15223-1:2012: Medical devices Symbols to be used with medical device labels, labeling, and information to be supplied – Part 1: General requirements.
In-Vitro Diagnostic and Medical Device Symbols
Manufacturer
Date of Manufacturer
Use by Date
EC Representative
Batch Code
Catalogue Number
Serial Number
Sterilize
Sterilize Use Aseptic Processing
Sterilize Use Ethyleneoxide
Sterilize Use Irradiation
Sterilize Use Steam Dryheat
No Resterilize
No Reuse
Nonsterile
Instruction For Use
Caution
Natural Rubber Latex
Damaged Pack
Sterile fluid Path
Fragile
Sunlight Away
Heat Radioactive Away
Keep Dry
Temperature Low limit
Temperature Upper limit
Temperature Limit
Humidity
Atmospheric Pressure
Biological Risk
Unique Device Identifier
Medical Device
Translation
Sterilized Vaporized Hydrogen Peroxide
Single Patient Multiple Use
Repackaging
Patient Information Website
Patient Identification
Human Blood Plasma Derivatives
Healthcare Centre Doctor
Biological Material Animal Origin
Biological Material Human Origin
Hazardous
Non Pyrogenic
In Vitro Diagnostic
Sampling Site
Disclaimer
The above Medical Device Symbols images are not in the required pixels or size and are not the exact representation of the standard. The above information is intended for informational purposes only and should not be construed as legal advice for regulatory submissions.
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Frequently Asked Questions
Where can we purchase the symbols?
Is it mandatory all symbols must be in the primary label?
No. If you have space constraints, you may use a single logo “read information for use” in the primary label. The remaining symbols are fixed in the IFU/User manual.