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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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International Standards Bodies - World Wide Standards Bodies

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SAE - Society of Automotive Engineers

Quality Digest

IEST - Institute of Environmental Sciences and Technology

Medical Device Related Standards - Sub-Forum(s) Search this Forum
  Forum Last Post or Poll Vote Threads Posts
ISO 13485 - Medical Device Quality Management System Requirements for Regulatory Purposes - (ISO 14969 has been replaced by ISO 13485:2016).
by yodon
17th February 2018 11:34 AM Go to last post
2,198 16,537
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 yodon
23rd February 2018 02:51 PM Go to last post
252 2,139
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.
22nd February 2018 10:55 PM Go to last post
686 4,415
IEC 62304 - Requirements for a development life cycle of medical device software, including medical device software risk management.
by scobb00
12th February 2018 11:19 AM Go to last post
152 1,186
Application of usability (human factors engineering) engineering to medical devices.
7th November 2017 09:35 AM Go to last post
38 424
Medical Device Related Standards not listed in the above sub-forums.
23rd February 2018 02:28 PM Go to last post
287 1,826

Medical Device Related Standards - Discussion Threads Forum Tools Search this Forum
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