Home-use medical devices enjoy increasing popularity because they can:
- be used in the home and other environments with minimal intervention of clinicians
- communicate relevant data to medical staff via advanced communications technologies
- help keep patients out of hospitals and reduce re-admissions
- help manage healthcare costs by reducing the amount of time patients need to spend with clinicians
Whether intended for the home or use by professional healthcare providers, manufacturers must ensure their smart medical devices and wearables remain safe to use and secure from cyber threats, and that all data gathered, stored and shared with other healthcare services and providers remains private.
All of these aspects are covered by an increasing number of standards and regulations, which must be adhered to.
IEC TC 62 produces international standards and other publications concerning electrical equipment, electrical systems and software used in healthcare and their effects on patients, operators, other persons, and the environment.
These standards are also used in testing and certification:
Common aspects of electrical equipment used in medical practice
Diagnostic imaging equipment
Equipment for radiotherapy, nuclear medicine and radiation dosimetry