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IEC/TR 60601-4-1 Ed. 1.0 en:2017

Medical electrical equipment - Part 4-1: Guidance and interpretation - Medical electrical equipment and medical electrical systems employing a degree of autonomy
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IEC/TR 60601-4-1 Ed. 1.0 en:2017

Medical electrical equipment - Part 4-1: Guidance and interpretation - Medical electrical equipment and medical electrical systems employing a degree of autonomy

PUBLISH DATE 2017
IEC/TR 60601-4-1 Ed. 1.0 en:2017

Medical electrical equipment - Part 4-1: Guidance and interpretation - Medical electrical equipment and medical electrical systems employing a degree of autonomy.

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.

SDO IEC: International Electrotechnical Commission
Document Number IEC/TR 60601
Publication Date May 1, 2017
Language en - English
Page Count 84
Revision Level 1.0
Supercedes
Committee 62A
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