I am preparing an insulation diagram prior to testing a device against IEC 60601-1. How do I determine the dielectric strength test voltage? I couldn't find anything in -1.
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You have asked a question that is an endpoint to the answers of 10-200 more detailed questions. The answer needs much experience with 60601-1
Taking the very simple question one level of hierarchy, how much insulation is necessary?
Going down another level:
- What are the values of voltages to which the patient and operator may be exposed
- Is any part of the medical device applied to the patient; is there a patient connection; to what body part is the patient connection.
- What surfaces of the medical device are accessible to the patient, the operator, and a case where the operator touches a surface and simultaneously touches the patient. Is there a negligible probability the patient or operator can access these surfaces?
We can go further and further down the hierarchy, to the point where we ask if your instructions for use limit the selection of equipment that is connected to your device.
I strongly suggest your firm retains a consultant. Very few people have the time to walk you through the electrical hazards section of 60601-1. Reading it is just a start --the specification is written in a general way to avoid implementation details. It takes a year or 1-2 projects or to understand the correspondence of general vague terms to physical objects and design constraints. I think your project risk is unacceptably high without a 60601 expert that can help guide your design (I am not a consultant so I cannot help)
