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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.


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Medical Device Related Standards - Sub-Forum(s) Search this Forum
  Forum Last Post or Poll Vote Threads Posts
Medical Device Quality Management Systems Standards - ISO 13485 and ISO 14969.
1st April 2015 12:15 PM Go to last post
1,961 14,794
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.
by lama01
25th March 2015 05:02 PM Go to last post
208 1,785
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.
by bcsnave
1st April 2015 02:31 PM Go to last post
564 3,825
IEC 62304 - Requirements for a development life cycle of medical device software, including medical device software risk management.
by Szaki87
26th March 2015 11:22 AM Go to last post
129 1,076
Application of usability (human factors engineering) engineering to medical devices.
29 330
Medical Device Related Standards not listed in the above sub-forums.
by iVivien
1st April 2015 03:26 AM Go to last post
230 1,531

 
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