People and power don’t mix well, and that is especially true when the people are patients – either in a medical facility or, increasingly, in a home environment. In order to ensure the safety of both patients and healthcare professionals, the healthcare business is heavily regulated by a range of standards-based requirements and associated product testing.
Central to the standards regime is IEC 60601, which is comprised of a suite of requirements specifically for the electrical and electronic equipment used in healthcare. Originally published some 40 years ago, IEC 60601 has kept pace with industry changes.
In this technical article, we examine some of the key principles of IEC 60601 as they relate to the implementation of the power supply, as well as some of the new requirements, such as the need for risk assessment. Additionally, practical ways for achieving compliance will be reviewed, such as the support that is available for medical device manufacturers.