Medical Tests

Medical Tests

EUROLAB has many years of experience in supporting the medical and medical products market. We take the medical device test very seriously to ensure reliability, precision and endurance to help keep patients and users safe. 

Medical Tests

As technology advances and medical equipment continues to evolve, the need for professional and expert tests will increase. EUROLAB works with medical device manufacturers to perform the required tests to meet the North American, European and other international markets for product quality, regulatory compliance, and agency certificates to help deliver products to the market quickly and cost-effectively.

Even when no test protocol is created, our engineers can help you focus on the most useful tests for your product development process.

Medical device testing and engineering services include:

  • EMC, EMI Test and Pre-Scan
  • Global Market Access and International Approvals
  • Product Safety Test and CE Mark
  • FDA Coexistence Test
  • Electronic Reliability and Material Testing and Evaluation
  • Environmental Tests
  • Root Cause Failure Analysis
  • Endurance Test
  • Chemical Exposure Test

Our extensive network of professionals and laboratory resources provides a unique ability to develop programs that provide the most useful and cost-effective solutions in the industry. Most of our medical industry clients prefer to work with us because of our reputation and our first-class EMC lab capabilities. Our customers often use other services to help meet their global and product development plans.

Electromagnetic Compatibility of Medical Devices (EMC)

EUROLAB is fully equipped and as required by your specific project to perform preconformity scans, electrostatic discharge (ESD), radiating RF immunity, electrical rapid transitions, surge testing, conducted immunity, magnetic H-fields, voltage drops and disconnections, all other EMC services emitted. it offers emissions, harmonics and vibration and more.

Standards recognized by the common EMC include:

  • IEC 60601-1-2– Medical Device Part 1 - 2: General Requirements for Basic Security and Basic Performance - Requirements and Tests
    Also valid as applicable EN / IEC 606001-2-xx for certain devices
  • ANSI / RESNA WC2 - Standard for Wheelchairs - Volume 2: Additional Requirements for Electric System Wheelchair (including scooter).
  • ANSI C63.19, Compatibility Measurement Methods Between Wireless Communication Devices and Hearing Devices
  • Applicable FCC Standards
  • FCC Part 15 Radio Frequency Devices
  • Chapter 15 Subpart B: Involuntary Radiators
    Chapter 15 Subpart C: Intentional Radiators
    Chapter 15 Subpart D: Unlicensed Personal Communication Service Devices
    Chapter 15 Subpart E: Unlicensed National Information Infrastructure Devices

Basic Test of Radio Frequency Identification (RFID) of Medical Devices

The technology that hospitals and healthcare facilities use the most today is a technology used for RFID, inventory and equipment tracking, and it makes an important job faster and more accurate than ever to match patients with the right drugs. As these technologies and applications evolve, they also increase their potential to interact with other electronic medical devices such as pacemakers.

Our test team, working with medical devices, performs RFID susceptibility testing to reveal all RFID problems and RFID emissions that may occur in your product.

With the expansion of radio frequency (RF) wireless technologies, your wireless medical device must coexist in harmony with a hospital, doctor's office, clinical setting, or other wireless devices in the patient's home. EUROLAB can evaluate your FDA Wireless compliance test needs and develop a test plan.

Medical Device EMC and RF Test

EUROLAB can establish EMC compliance tests on a wide range of medical devices and equipment listed below, by establishing various collaborations.

  • Light Therapy Devices
  • Surgical Microscopes
  • Eye Scan Analysis Tools
  • Muscle Stimulation Devices
  • AED Devices
  • Glucose Monitors
  • Repeater Pumps
  • UV Blood Sterilizers
  • Medical Waste Disposal Devices
  • Electric Wheelchairs
  • Large and Small Surgical Systems and Devices

Focused Medical Technology Test

Perfection is what you need in your medical device software and hardware because these devices are directly related to people's life. EUROLAB is always by your side to help you achieve this with certification programs, FDA requirements, software compatibility and interoperability, functionality, performance and usability tests for all types of devices such as monitors, hand-held electronic devices, computers and peripherals and more.

The main areas of research for FDA guidance on medical and wearable devices are:

  • Wireless Coexistence
  • Yield
  • Data integrity
  • Security
  • EMC

Our highly experienced engineers focus on product validation requirements (21 CFR 820.30) as well as design validation (21 CFR 820.30) and risk management processes and procedures. EUROLAB prepares a customized test plan, performs the test and helps submit to FDA approval.

Medical Device Environmental Test

Environmental tests for medical devices cover a wide range of test disciplines. Our engineers can help you determine the best environmental tests for your medicinal product based on their end use.

As we do for many medical device manufacturers, we can add environmental tests to your EMC test programs for a more comprehensive evaluation of your product. Some examples of environmental tests in medical devices include:

  • Altitude, humidity, vibration, sensitivity, drop, input, EMC and vibration of an AED device
  • Non-reverberant room test, shock and load, slow thermal cycle and moist heat test, vibration, impact and shock in surgical microscopes
  • Package testing, random vibration, transport and height testing in heart pump controllers
  • Altitude, humidity, vibration, sensitivity, drop, input, EMC and vibration of an AED device
  • Non-reverberant room test, shock and load, slow thermal cycle and moist heat test, vibration, impact and shock in surgical microscopes
  • Package testing, random vibration, transport and height testing in heart pump controllers

Material testing for medical devices

EUROLAB has equipment to test from thermoplastics to adhesives, composites to glass, thermosets to titanium, implantable devices, printed circuit boards, electronic components and more. Reliability and product comparison studies are routinely conducted and can be important assessment tools for medical devices. Material testing includes:

  • Root cause failure analysis of medical electronics and non-electronic device field returns
  • Component analysis, standard radiography and computed tomography (CT) of hearing implants
  • Pollution analysis of handheld wireless diagnostic tools
  • Mechanical properties of non-electronic devices (pulling, bending, compression, hardness, etc.)
  • Cleaning test of surgical instruments
  • Cleaning procedure validation of endoscopes

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