Featured Blog
The Path to Production: Insights from the 2024 Bioprocessing Summit in Boston
November 4, 2024
Featured Case Study
Consumable A/pH Sensors for Dialysis – From Multiple, Manual Processes to a Faster, Automated Manufacturing Line While Maintaining Critical Tolerances and Mitigating Safety Risks
September 25, 2024
Access sales materials and thought leadership.
Resources
Access sales materials and thought leadership.
Discover the industry-leading brands that support our test and measurement automated solutions.
Resources
Access sales materials and thought leadership.
Press
Read the latest news and product announcements.
Resources
Access sales materials and thought leadership.
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.
