1 Scope
This Part of IEC 60601 is intended to help a manufacturer through the key decisions and steps to be taken to perform a detailed risk management and usability engineering processes for medical electrical equipment or a medical electrical system, hereafter referred to as mee or mes, employing a degree of autonomy (doa).
This document provides a definition of doa of mee or mes and a medical robot, and also provides guidance on:
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— methodologies to perform the risk management process and usability engineering for an mee or mes with a doa;
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— considerations of basic safety and essential performance for an mee and mes with a doa; and
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— identifying the use of doa, and similar concepts in existing ISO/IEC standards dealing with mee or mes with the goal to facilitate alignment of standards by consistent use of the concept of doa; and
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— distinguishing between medical robots, and other mee and mes.
Unless specified otherwise, this document considers mee and mes together.
The manufacturer of an mee or mes with a doa is expected to design and manufacture
an mee or mes that fulfils its intended use and does not have unacceptable risk throughout its life-cycle.
This document provides guidance to help the manufacturer in complying with the requirements of IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012 for mee and mes with doa. The document is also intended as guidance for future standard writers.
There are no prerequisites to this document.