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PD IEC/TR 60601-4-1:2017
Medical electrical equipment Guidance and interpretation. Medical electrical equipment and medical electrical systems employing a degree of autonomy
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Označení normy: | PD IEC/TR 60601-4-1:2017 |
Počet stran: | 84 |
Vydáno: | 2017-06-23 |
ISBN: | 978 0 580 84736 3 |
Status: | Standard |
DESCRIPTION
PD IEC/TR 60601-4-1:2017
This standard PD IEC/TR 60601-4-1:2017 Medical electrical equipment is classified in these ICS categories:
- 11.040.01 Medical equipment in general
- 33.160.30 Audio systems
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.