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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

ASQ - American Society for Quality

International Standards Organization - ISO Standards and Information

NIST's Engineering Statistics Handbook

IRCA - International Register of Certified Auditors

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ISO 13485 - Medical Device Quality Management System Requirements for Regulatory Purposes - (ISO 14969 has been replaced by ISO 13485:2016).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
26th July 2017 11:22 AM Go to last post
2,089 15,768
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 Jean_B
26th July 2017 10:07 AM Go to last post
243 2,055
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.
19th July 2017 01:39 PM Go to last post
656 4,275
IEC 62304 - Requirements for a development life cycle of medical device software, including medical device software risk management.
by yodon
24th July 2017 01:53 PM Go to last post
147 1,157
Application of usability (human factors engineering) engineering to medical devices.
by yodon
6th July 2017 10:50 AM Go to last post
36 407
Medical Device Related Standards not listed in the above sub-forums.
by Pascalb
21st July 2017 10:18 AM Go to last post
274 1,752

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