Medical Device Testing

Medical Device Testing

NTS’ laboratories have extensive experience supporting the invasive and non-invasive medical products market. As technology advances and medical equipment becomes more and more sophisticated, the need for testing has increased.

NTS works with our customers to determine the testing they need to meet FDA, product safety, and other certifications needed to bring their products to market quickly. In some cases, where no testing protocol is established, our engineers assist customers to determine what testing will be the most beneficial to the product development process.

NTS offers a variety of test and engineering services to medical device manufacturers. These include:

Our extensive experience and capabilities allows us to develop test programs which combine many of these test services. Many of our medical sector customers come to us for EMC testing and opt to include the global approvals required for their products end market.

Electromagnetic Compatibility for Medical Devices (EMC)

EMC testing is a vital component of the testing needed for medical device compliance. NTS has over 50 chambers across the US and Canada ranging in size from 3 meter to 10 meter. In addition to the EMC testing, we offer EMC pre-compliance scans, electrostatic discharge (ESD), radiated RF immunity, electrical fast transients, surge, conducted immunity, magnetic H-fields, voltage dips and interrupts, radiated and conducted emissions, harmonics and flicker.

FDA EMC Recognized Standards:

  • IEC 60601-1-1 – Medical Equipment Part 1 – 2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements and Tests
  • AAMI / ANSI / IEC 60601-1-2 – Medical Electrical Equipment Part 1 – 2: General Requirements for Basic Safety and Essential Performance – Collateral Standard: Electromagnetic Disturbances - Requirements and Tests
  • ANSI / RESNA WC2 – Standard for Wheelchairs - Volume 2: Additional Requirements for Wheelchairs (including scooters) with Electrical Systems.
  • ANSI C63.19, Methods of Measurement of Compatibility between Wireless Communication Devices and Hearing Aids
  • Applicable FCC Standards
    • FCC Part 15 Radio Frequency Devices
  • Part 15 Supbart B: Unintentional Radiators
  • Part 15 Subpart C: Intentional Radiators
  • Part 15 Subpart D: Unlicensed Personal Communications Service Devices
  • Part 15 Subpart E: Unlicensed National Information Infrastructure Devices

Radio Frequency Identification (RFID) for Medical Devices

RFID systems are increasingly common in health care and hospital settings. Uses range from inventory and equipment tracking, to ensuring that the right patient receives the right medication. As this technology is more widely used, the need for understanding the products potential for interfering with other electronic medical devices, such as pacemakers, has also increased.

NTS medical device testing facilities perform RFID susceptibility testing to help our customers identify any RFID emissions their product might have.

With the expansion of radio frequency (RF) wireless technologies, it is imperative that your wireless medical device peacefully coexists with other wireless devices in a hospital, doctor’s office, clinical environment, as well as consumer and commercial environments. NTS can evaluate you FDA Wireless Coexistence testing needs, develop a test plan, and work with you to submit results to the FDA for their review and approval.

EMC and RF Testing at NTS

NTS has assisted many customers with their medical device EMC compliance testing. Some examples include:

  • Light therapy devices
  • Surgical microscopes
  • Eye scanning analysis tools
  • Muscular stimulation devices
  • AED devices
  • Glucose monitors
  • Repeater pumps
  • UV Blood sterilizers
  • Medical waste disposal devices
  • Electric wheelchairs
  • Large and small surgical systems and devices

Technology Testing of Medical Devices

NTS’ Advanced Technology division provides a wide range of services associated with the software and hardware technology involved in many of today’s medical device products. Certification to specific standards such as USB, FDA coexistence, software compatibility and interoperability, functionality, performance and usability are all routinely conducted. Products tested include monitors, handheld electronic devices, computers and peripherals.

The primary focal areas for the FDA Guidance for medical/wearable devices are wireless coexistence, performance, data integrity, security, and EMC. Our Advanced Technology engineers focus on the identification, documentation and implementation of product design requirements (21 CFR 820.30), the design verification and validation (21 CFR 820.30) and risk management process and procedures.

NTS will prepare a customized test plan, execute the testing, and help with the submission for FDA approval.  

Environmental Testing of Medical Devices

Environmental testing covers a wide variety of test disciplines. Our engineers can help you determine what the best environmental tests are for your medical product depending upon the products end use. Environmental testing is often added on to our customers EMC testing programs for a more complete evaluation of their products.

Some examples of environmental testing we have conducted on medical devices include:

  • Altitude, humidity, vibration, susceptibility, drop, ingress, EMC, and vibration of an AED device
  • Anechoic chamber testing, shock and load, slow thermal cycle and damp heat testing, vibration, bump and shock on surgical microscopes
  • Package testing, random vibration testing, shipping, and altitude conducted on heart pump control units
  • RF, ESD, Immunity, Package, Radiated Emissions, RE, Shock, Temp, Drop, Environmental testing for large surgical systems
  • Ingress protection (IP) and engineering pre-scan of a li-ion batteries
  • Blowing sand, dust and rain, ingress, shock and vibration of remote, Wi-Fi, patient monitoring systems
  • Acoustic noise testing, pull testing, sound testing, temperature, and abrasion testing of breast pumps
  • Environmental testing of patient temperature management devices
  • Altitude testing on respiratory ventilators
  • Noise testing of blood gas analyzers
  • Enclosure protection of Bluetooth medication trackers
  • Shock and vibration of infusion pumps
  • Vibration testing of work station carts, cables, microscopes, pumps
  • Environmental exposure and durability testing of medication delivery systems such as IV pumps

Materials Testing for Medical Devices

NTS Materials testing services can evaluate everything from thermoplastics to adhesives, composites to glass, thermosets to titanium, implantable or implantable devices, printed circuit boards  to electronic components, and more. Reliability and product comparison studies are routinely conducted and can be important evaluative tools for medical devices.

Some examples of materials testing we have conducted:

  • Root cause failure analysis of medical electronics and non-electronic device field returns
  • Component analysis, standard radiography, and computer tomography (CT)  of hearing implants
  • Contamination analysis of handheld wireless diagnostic tools
  • Mechanical properties (tensile, flexure, compression, hardness, etc.) of non-electronic devices
  • Cleanliness testing of surgical tools
  • Cleaning procedure validation of endoscopes