IEC 62366-1 Ed. 1.1 b:2020, First Edition: Medical devices - Part 1: Application of usability engineering to medical devices
by International Electrotechnical Commission
This international standard specifies usability engineering processes for medical device design to help ensure safety and effectiveness.
About This Book
This standard provides requirements and guidance for manufacturers on incorporating usability engineering into the development of medical devices.
It outlines a process to analyze, specify, design, verify, and validate usability aspects related to safety.
The document supports compliance with regulatory expectations for safe and effective device interaction.
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