Quality Certifications and Design Standards

Design Standards


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

Military Design 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 Standards

    General

  • US FDA 21 CFR, Part 820          Quality System Regulation
  • MDD 93/42/EEC                          Medical Device Directive
  • ISO 13485                                     Quality Management Systems
  •  

    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

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