Search the Elsmar Cove!
**Search ALL of Elsmar.com** with DuckDuckGo including content not in the forum - Search results with No ads.
  • Google has changed ad sizes for some reason. I am investigating and will get the sizes reduced to what they have been until now. I apologise for the inconvenience.

Medical Device Related Standards

Medical devices standards, national and international. Standards are published by standards writing bodies (such as ISO and IEC internationally, ANSI, CEN, CENELEC, CSA and others nationally) and are generally voluntary. You can use standards to fulfill regulations, depending on the way the regulation uses standards.

ISO 13485:2016 - Medical Device Quality Management Systems

ISO 13485 - Medical Device Quality Management System Requirements for Regulatory Purposes - (ISO 14969 has been replaced by ISO 13485:2016).
Threads
2,443
Messages (Posts)
18,284
Threads
2,443
Messages (Posts)
18,284

ISO 14971 - Medical Device Risk Management

ISO 14971 - Medical Device Risk Management and Hazard Control: Identifying and controlling the risks and the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices.
Threads
281
Messages (Posts)
2,381
Threads
281
Messages (Posts)
2,381

IEC 60601 - Medical Electrical Equipment Safety Standards Series

The IEC 60601 standards series covers safety and performance issues of medical electrical equipment, and also topics such as EMC and alarms. This sub-forum includes collateral (IEC 60601-1-X) and particular (60601-2-x) standards.
Threads
816
Messages (Posts)
5,135
Threads
816
Messages (Posts)
5,135

IEC 62304 - Medical Device Software Life Cycle Processes

IEC 62304 - Requirements for a development life cycle of medical device software, including medical device software risk management.
Threads
177
Messages (Posts)
1,347
Threads
177
Messages (Posts)
1,347

IEC 62366 - Medical Device Usability Engineering

Application of usability (human factors engineering) engineering to medical devices.
Threads
47
Messages (Posts)
474
Threads
47
Messages (Posts)
474

Other Medical Device Related Standards

Medical Device Related Standards not listed in the above sub-forums.
Threads
332
Messages (Posts)
2,018
Threads
332
Messages (Posts)
2,018
Discussions
Top Bottom