Medical Device Design Standards

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Military Product Design Standards

D&K Engineering has experience designing, testing and performing validation and verification activities to the following military, medical and agency standards.

  • Mil-Std-464 Electromagnetic Compatibility
  • Mil-Std-461 EMI/RFI
  • Mil-Std-167-1 Vibration of rotating machinery
  • Mil-Std-810 Environmental testing
  • Mil-Std-740 Acoustic noise
  • Mil-S-901D Shock testing
  • Mil-M-17060 AC induction motors for Navy service
  • IEEE-841 AC induction motors for severe duty
  • Mil-E-917 Electrical equipment basic requirements
  • Mil-E-2036 Electrical enclosures
  • DOD-Std-1399 Shipboard interfaces
  • IEEE-45 Maritime electrical systems
  • MIL-PRF-32006 Programmable Controller, Naval Shipboard
  • MIL-PRF-32168 Variable Speed Drive System for Induction and Synchronous Machines

Medical Device Design Standards

General

Risk Management

  • ISO 14971 Medical Devices
  • IEC 60812 Analysis techniques for system reliability
  • IEC 60601-1-8 Alarm systems in medical electrical equipment and medical systems

Electrical Safety

  • IEC 60601-1:2005 Medical Electrical Equipment. Part 1: General Requirements for Safety
  • IEC 60601-1-2:2005 Medical Electrical Equipment. Part 1-2: Collateral Standard: Electromagnetic Compatibility
  • CSA C22.2 No. 601.1-M90 Medical Electrical Equipment
  • IEC 60601-1-4 Medical electrical equipment

Environmental Compatibility

  • IEC 60529 Part 1 Degrees of protection provided by enclosures
  • IEC 60068-2-29 Environmental Testing: -29 Bump, -27 Shock, -6 Sine Vibration, -64 Random Vibration

Human Factors

  • ANSI/AAMI HE74:2001 Human Factors Design Process
  • IEC 60601-1-6 Collateral Standard – Usability
  • General Standards

Other

  • FCC Class A
  • UL, various requirements
  • TUV
  • CE (safety and radiated emissions)
  • CSA, various requirements
  • REACh
  • RoHS (multiple countries)
  • C-TICK, Class A

To learn more about our military product designs standards and medical device design standards, contact our team today.