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Military Product Design Standards – Medical Device Design Standards – D&K Engineering
Speak with an ExpertD&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.
