IEC 601-1-4 Requirements/Compliance
International Standard IEC 601-1-4 was prepared by IEC technical committee 62: Electrical equipment in medical practice. It constitutes a collateral standard to IEC 60 I-1: Medical electrical equipment-Part 1: General requirements for safoty. It requires that a process be followed and that a record of that process be produced to support the safety of medical electrical equipment incorporating programmable electronic subsystems. The concepts of risk management and a development life cycle that are the basis of this standard can also be of value in the development of medical electrical equipment that does not include a programmable electronic subsystem.