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Impossible? Done.

D&K Engineering is now Ascential Medical & Life Sciences.

Ascential Medical and Life Sciences tackles the hardest challenges that simply cannot fail, delivering high-quality design, development, manufacturing and automation solutions at scale.

This site is no longer maintained but is preserved for reference and archival purposes.

Impossible? Done.

Go to ascentialtech.com

D&K Engineering is now Ascential Medical & Life Sciences.

Ascential Medical and Life Sciences tackles the hardest challenges that simply cannot fail, delivering high-quality design, development, manufacturing and automation solutions at scale.

This site is no longer maintained but is preserved for reference and archival purposes.

Medical Device Design Standards

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.