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Safety and Performance Testing

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IEC 60601 & IEC 61010 testing and certification services*Active Medical Electrical Equipment & Inactive Medical Mevices

In the field of active medical devices/electrical equipment, the testing and certification requirements are documented and internationally harmonized under the standard family IEC 60601. Due to identical requirements of IEC and EN 60601, IEC defines the assumption of conformity to the Medical Device Directive (MDD) 93/42/EEC.

In vitro diagnostic medical devices testing and certification requirements must be in accordance with IEC 61010-101 which is called up by the In Vitro Diagnostic Devices Directive (IVDD) 98/79/EC.

Eurofins Medical Device Testing performs safety and essential performance testing according to IEC 60601 and IEC 61010 standards for medical electrical equipment and in vitro diagnostic medical devices. We document the results with test reports and certificates, and offer notified body and NRTL services.

Our Eurofins Medical Device Testing and Certification services are provided through our global network of Eurofins Electrical & Electronics (E&E) laboratories, which are supervised by regular inspections of the IEC Assessors and documented within the listing on the IECEE Website.

Our scope of accreditation includes international standards for accessing worldwide markets, including product safety compliance in the United States and Canada (FDA and Health Canada) and OSHA NRTL requirements through Eurofins MET labs including:

  • EN 60601-1 Base standard
  • IEC 60601-1-1 Systems
  • IEC 60601-1-2 EMC (3rd & 4th Edition)
  • IEC 60601-1-3 Radiation protection
  • IEC 60601-1-4 and IEC 62304 PEMS
  • IEC 60601-1-6 and IEC 62366 Usability
  • IEC 60601-1-8 Alarms
  • IEC 60601-1-9 Environmentally conscious design
  • IEC 60601-1-11 Home Health Care Environment
  • IEC 60601-1-12 EMS environment
  • IEC 60601-2-10 Stimulation
  • IEC 60601-2-18 Endoscopic
  • IEC 60601-2-25 & IEC 60601-2-27 ECG
  • IEC 60601-2-31 External Pacemaker
  • IEC 60601-2-32 X-ray
  • IEC 60601-2-34 Invasive blood pressure monitoring
  • IEC 60601-2-37 Ultrasonic diagnostic and monitoring
  • IEC 60601-2-40 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
  • ISO 7176-9 & RESNA WC-1:2009 Electric wheelchairs

Eurofins Medical Device Testing’s certification services also include global market access, Notified bodies, NRTL’s, CB Scheme, Medical Devices Single Audit Program (MDSAP) and ISO 13485 Quality Management Systems audits

4th edition of IEC 60601-1-2

The new, 4th Edition of IEC 60601-1-2 for EMC comes into force on 31st December 2018, superseding the 3rd edition and bringing with it a number of significant changes.  All manufacturers with products currently on the market and in development need to be ready for this change. Eurofins Medical Device Testing and certification services’ compliance experts are on-hand to help you through this process.

Choose Eurofins Medical Device Testing to help you:

✔ Check basic safety and essential performances including to FDA and Health Canada guidance documents
✔ Ensure conformity to IEC 60601 standards for the MDD 93/42/EEC
✔ Ensure conformity to IEC 61010 standards for the IVDD 98/79/EC
✔ Document test results in test reports and certificates
✔ Obtain CB test reports and certificates
✔ Access global markets through a single point of contact

*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 enquire on a case by case basis.

 

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