Applied parts classification (Type B, BF, CF), means of patient and operator protection, allowable leakage current limits, and the essential performance concept.
IEC 60601-1 is the collateral standard every electrically powered patient-contact medical device must comply with to be legally marketed in essentially every major jurisdiction, organized around two core concepts: basic safety, freedom from unacceptable risk from physical hazards like electric shock, and essential performance, the clinical function whose loss or degradation itself creates unacceptable risk — a distinction this module builds from the ground up.
It then covers applied parts classification (Type B, BF, and CF, ranked by degree of patient protection against leakage current, with CF required for direct cardiac contact), the means of patient protection and means of operator protection the standard mandates, and the allowable leakage current limits and essential performance requirements that directly govern the cardiac device designs covered in Module 14 and the biosignal amplifier front end built in Project 4.