International Standard
IEC/TR 60601-4-1:2017
Medical electrical equipment — Part 4-1: Guidance and interpretation — Medical electrical equipment and medical electrical systems employing a degree of autonomy
Reference number
IEC/TR 60601-4-1:2017
Edition 1
2017-05
International Standard
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IEC/TR 60601-4-1:2017
70755
Published (Edition 1, 2017)

IEC/TR 60601-4-1:2017

IEC/TR 60601-4-1:2017
70755
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CHF 345
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Abstract

IEC TR 60601-4-1:2017(E) 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: - methodologies to perform the risk management process and usability engineering for an MEE or MES with a DOA; - considerations of basic safety and essential performance for an MEE and MES with a DOA; and - 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 - 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.

General information

  •  : Published
     : 2017-05
    : International Standard published [60.60]
  •  : 1
     : 80
  • ISO/TC 299
    11.140 
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