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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.
1,978 14,951
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.
24th May 2015 02:56 PM Go to last post
214 1,827
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.
26th May 2015 07:13 AM Go to last post
573 3,885
IEC 62304 - Requirements for a development life cycle of medical device software, including medical device software risk management.
22nd May 2015 06:42 PM Go to last post
131 1,090
Application of usability (human factors engineering) engineering to medical devices.
29 337
Medical Device Related Standards not listed in the above sub-forums.
by Pads38
26th May 2015 04:08 AM Go to last post
236 1,559

 
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