Usability testing is a technique used in user-centered interaction design to evaluate a product by testing it on users. This can be seen as an irreplaceable usability practice, since it gives direct input on how real users use the system.[1] This is in contrast with usability inspection methods where experts use different methods to evaluate a user interface without involving users.

Usability testing focuses on measuring a human-made product's capacity to meet its intended purpose. Examples of products that commonly benefit from usability testing are foods, consumer products, web sites or web applications, computer interfaces, documents, and devices. Usability testing measures the usability, or ease of use, of a specific object or set of objects, whereas general human-computer interaction studies attempt to formulate universal principles.


Setting up a usability test involves carefully creating a realistic scenario, or situation, wherein the clinician performs a list of tasks using the equipment being tested under extreme stress while clinical engineers observe, ask questions, and take notes. Several other test evaluations are scripted instructions, pre- and post-test questionnaires are also used to gather feedback on the equipment being evaluated. For example, to test the equipment for durability, a scenario would describe a situation where a nurse accidentally drops an Infusion Pump from a 6' IV pole onto the floor, and ask him or her to undertake this task. The aim is to observe how clinicians function in a realistic manner, so that original equipment manufacturers can address these problem areas, design the equipment for these types of crashes and falls and design medical devices to what the users want. Another test example, is a situation where a nurse tries to silence an alarm, and again ask him or her to undertake this task. The aim is to observe how clinicians function in a realistic manner, so that Original Equipment Manufacturers (OEM) can once again address these problem areas, properly design the equipment and again the medical devices to what the users want. These techniques and others are popularly used to gather data and should be submitted to the OEM engineers for evaluation and re-design.

Additional test methods are:

  • Electrostatic discharge (ESD)
  • Radiated RF electromagnetic energy
  • Conducted RF electromagnetic energy
  • Magnetic fields
  • Electrical fast transients and bursts
  • Power Surges
  • Voltage dips
  • Short interruptions
  • Voltage variations on power supply input lines
  • Vibration and shock 
  • Temperature and Humidity
  • Other enviromenal factors
  • Bump Test
  • Drop test[1]


These are standards IAW Class I Devices used for testing:

  • EU/EMC 93/42/EEC
  • FDA’s Pre-market guidance requirements (21 CFR)
  • IEC 60601-1-2 – 2001Safety/MI/EMC
  • R&TTE - Directive for Intentional Radiators
  • 47 CFR. Part 15
  • IEC 801
  • FCC, Part 18
  • ANSI C63.18
  • ISO 9001


  1. Dayton T. Brown Inc. Engineering & Test Division. "Testing Services for the Medical Device Market". Accessdate 26 Dec 2013.