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.
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.
Medical Device Symbols used in Active & Non Active Devices
Date of Manufacturer
Use by Date
Sterilize Use Aseptic Processing
Sterilize Use Ethyleneoxide
Sterilize Use Irradiation
Sterilize Use Steam Dryheat
Instruction For Use
Natural Rubber Latex
Sterile fluid Path
Heat Radioactive Away
Temperature Low limit
Temperature Upper limit
Unique Device Identifier
Sterilized Vaporized Hydrogen Peroxide
Single Patient Multiple Use
Patient Information Website
Human Blood Plasma Derivatives
Healthcare Centre Doctor
Biological Material Animal Origin
Biological Material Human Origin
In Vitro Diagnostic
The above Medical Device Symbols images are not in required pixels or size and not the exact representation of standard. The above information is intended for informational purposes only and should not be construed as legal advice for regulatory submissions.