The phrases “intended use” and “normal use” may seem the same but, when working with medical devices, it is important to know the difference between the two. In medical device standards like EN 60601-1, the “Intended Use” is a subset of “Normal Use.”
What Is Intended Use?
Intended Use (Intended Purpose) is a description of the intended medical use of the device and its accessories, as presented by the manufacturer in their specifications, instructions, and other information.
The intended medical purpose of the device and its accessories, among other things, includes:
Patient Specifics
- The demographics of the intended patient population
- The parts of the body or types of tissue it will interact with
Mode of Operation
- Whether it is intended for continuous or non-continuous operation
Environmental Conditions
- Humidity
- Temperature
- Air pressure
- Shock and vibrations
- Ultra-violet radiation
- Pollution
Standard Operating Conditions
- Temperature of the part of the device or accessory that is likely to be touched
- Use with flammables like anesthetics
- Contact with biological tissues, cells, or body fluids
Operating Instructions
- Specifications
- Connecting and disconnecting detachable parts and accessories
- Replacing consumable materials, including spillage
- Shutdown procedures
What Is Normal Use?
Normal Use includes the medical Intended Use but goes on to describe the entire range of product use, according to the manufacturer’s instructions.
Normal Use, among other things, includes:
Intended Use
- The medical purpose (described above)
Maintenance
- Preventive inspection and adjustments
- Calibration
- Cleaning, disinfection, and sterilization
- Protection from liquids used or spilled
Transport and Storage
- Stands up to transportation, installation, and movement
- Sufficient resistance to impact (like being dropped)
- Cables plugged in and unplugged
The Two “Uses”
The easy way to recall the two terms is to remember that Intended Use describes the medical intention – what does it do? Normal Use describes the full operational lifecycle of the device — what does do and how does it keep doing it?
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