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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.
by theGrod
19th December 2014 11:13 AM Go to last post
1,923 14,469
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 Ronen E
18th December 2014 08:07 PM Go to last post
202 1,753
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 Pads38
18th December 2014 04:57 AM Go to last post
548 3,743
IEC 62304 - Requirements for a development life cycle of medical device software, including medical device software risk management.
6th December 2014 01:39 PM Go to last post
124 1,046
Application of usability (human factors engineering) engineering to medical devices.
7th August 2014 03:35 AM Go to last post
28 325
Medical Device Related Standards not listed in the above sub-forums.
17th December 2014 08:11 PM Go to last post
225 1,477

 
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