What is BS EN 62366-1 about?
BS EN 62366-1 Medical devices - Application of usability engineering to medical devices specifies a process for a manufacturer to analyze, specify, develop and evaluate the usability of medical devices. BS EN 62366-1 focuses on the usability engineering (human factors engineering) process which permits the manufacturer to assess and mitigate risks associated with medical devices to provide safety for the patient, user, and others.
BS EN 62366-1 can be used to identify but does not assess or mitigate risks associated with abnormal use. And intended to be useful for the technical committees which are responsible for the preparation of medical device standards.
Who is BS EN 62366-1 for?
BS EN 62366-1 on the usability of medical devices is applicable to:
- Medical equipment and device manufacturers
- Medical surveillance teams
- Medical usability engineers
Why should you use BS EN 62366-1?
BS EN 62366-1 is based on the usability engineering process related to the risk management process related to the medical device. Usability has a greater impact when it comes to healthcare and medical devices, usability is lacking in medical devices which increases the chances of error, and to mitigate that this standard is issued.
BS EN 62366-1 focuses on usability engineering which is intended to identify and minimize and thereby reduce the use-associated risk.
