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Medical Testing Services

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Active Medical Devices and In Vitro Diagnostic Medical Devices

Our international network of Electrical and Electronics (E&E) laboratories provide the safety testing required for medical electrical equipment and active medical devices according to the Medical Devices Directive (MDD) 93/42/EEC and In Vitro Diagnostic Medical Devices Directive (IVDD) 98/79/EC.

The testing, certification and global market access approvals services we offer include those for the IEC 60601 series (for the MDD 93/42/EEC) and IEC 61010 series (for the IVDD 98/79/EC).

We provide test reports and certificates according to CB Scheme and ILAC accreditation. Through Eurofins MET labs we can also provide product safety compliance for the United States and Canada (FDA and Health Canada) including OSHA NRTL certification.

*Standards in our scope include all the necessary tests for safety and performance, electromagnetic compatibility (EMC) and radio/wireless testing including (but not limited to):

  • EN 60601-1; base standard
  • IEC 60601-1-1; medical electrical systems
  • IEC 60601-1-2 EMC (3rd & 4th Edition)
  • IEC 60601-1-3; radiation protection
  • IEC 62304; programmable electronic medical systems (PEMS)
  • IEC 60601-1-6 & IEC 62366; usability
  • IEC 60601-1-8; alarms
  • IEC 60601-1-9; environmentally conscious design
  • IEC 60601-1-10; physiological closed loop controllers
  • IEC 60601-1-11; home health care environment
  • IEC 60601-1-12; emergency medical services environment
  • IEC 60601-2-10; stimulation
  • IEC 60601-2-18; endoscopic
  • IEC 60601-2-27; electrocardiogram (ECG)
  • IEC 60601-2-31; external pacemaker
  • IEC 60601-2-34; invasive blood pressure monitoring
  • IEC 60601-2-37; ultrasonic diagnostic and monitoring
  • IEC 60601-2-40; electromyograph (EMG)
  • IEC 60601-2-46; operating tables
  • IEC 60601-2-49; patient monitoring
  • IEC 60601-2-52; medical beds
  • IEC 60601-2-54; X-ray equipment for radiography and radioscopy
  • IEC 60601-2-66; hearing aids
  • IEC 61010-2-101; in vitro diagnostic (IVD) medical equipment
  • IEC 80601-2-60; dental equipment
  • ISO 7176-9 & RESNA WC-1:2009; electric wheelchairs

*Where IEC standards are referred to, national and regional variations are also applicable including, but not limited to; ANSI/AAMI, UL, ISO, CAN/CSA, JIS, EN, ENV, BS EN, DD ENV and BS IEC.

Please inquire on a case by case basis for testing of your, active medical devices (often referred to as medical electrical equipment) and non-active medical devices.

Performance Testing

In addition to testing for compliance with the standards above, our medical device testing includes a fully comprehensive range of Performance Testing covering

  • Functionality
  • Energy Efficiency
  • Durability and reliability
  • Performance tests to many FDA Guidance Documents, AAMI and ANSI standards
  • Special tests to establish and/or validate claims on new medical devices
  • Unique testing facilities for special medical devices; electro-surgical devices, ultrasound equipment, electric wheelchairs etc.
  • Litigation support testing, expert witness
  • Failure analysis

Eurofins offer a range of additional services through our laboratory networks including Digital testing and cyber Security, and bio-compatibility/ bio-pharmacological testing.

 

Contact your local E&E laboratory to find out more about how we can help you gain the necessary certifications for your medical device(s).

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