Services available for Magnetic Resonance Imaging

IEC 60601-1 Testing and Certification

IEC 60601-1 Testing and Certification

We support you in the testing and certification of your medical devices and systems according to national and international standards and regulations, e.g. by application of IEC 60601 series
  • 4-6 week typical lead time
  • ISO 17025 Accredited testing program
  • IECEE CB Scheme testing and
  • US-NRTL certification according to ANSI/AAMI ES60601- 1 and CAN/CSA-C22.2 No. 60601-1
  • INMETRO certification for access to the Brazilian market
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IEC 60601-1-2 EMC Testing

IEC 60601-1-2 EMC Testing

We offer EMC test program for active medical devices and/or systems, which defines emission and immunity criteria per IEC 60601-1-2
  • 2-4 week typical lead time
  • ISO 17025 Accredited testing program
  • IECEE CB Scheme testing and
  • IEC 60601-1-2:2020 (ed. 4.1) – Medical electrical
    equipment
  • Review and verification of EMC test plans, risk analysis, and user manuals
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Accelerated Aging Testing

Accelerated Aging Testing

We perform accelerated aging testing and real time
ageing studies to determine how a products behave
under normal storage/use conditions over long periods
of time.
  • 3-4 week typical lead time
  • ASTM F1980 Sterile Barrier Systems & Medical Devices
  • ISO 11607 Packaging for terminally sterilized medical
    devices
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