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.

ISO 13485:2016 - Medical Device Quality Management Systems

ISO 13485 - Medical Device Quality Management System Requirements for Regulatory Purposes - (ISO 14969 has been replaced by ISO 13485:2016).
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ISO 14971 - Medical Device Risk Management

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.
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361
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3,201
Discussion Threads
361
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3,201

IEC 60601 - Medical Electrical Equipment Safety Standards Series

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.
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1,022
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IEC 62304 - Medical Device Software Life Cycle Processes

IEC 62304 - Requirements for a development life cycle of medical device software, including medical device software risk management.
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248
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1,780
Discussion Threads
248
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IEC 62366 - Medical Device Usability Engineering

Application of usability (human factors engineering) engineering to medical devices.
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592
Discussion Threads
58
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592

Other Medical Device Related Standards

Medical Device Related Standards not listed in the above sub-forums.
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