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

• 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

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.