| Publication CODE |
Title |
| IEC TR 60601-4-1:2017 (2017-05) |
MEDICAL ELECTRICAL EQUIPMENT - PART 4-1: GUIDANCE AND INTERPRETATION - MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS EMPLOYING A DEGREE OF AUTONOMY |
| |
| Price Excl. VAT |
Total number of pages, tables and drawings |
|
366.00 €
|
80. |
Description
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.
|
| Class |
C990
(IEC PUBLICATIONS IEC PUBLICATIONS)
|
| Status |
IEC PUBLICATION |
| Situation |
Currently active
|
|
| Committee |
TC 62/SC 62A
COMMON ASPECTS OF ELECTRICAL EQUIPMENT USED IN MEDICAL PRACTICE
|
| Responsible |
De heer VAN HECKE Luk
|
| BEC Approval |
2017-05-22 |
| ICS-Code (International Standards Classification) |
11.040.01
|
| NBN Status |
New |
|
| IEC publication date |
2017-05-22 |
| IEC stability date |
2022-12-31 |
| IEC file modification date |
2017-05-22 |
| IEC last modification date |
2019-10-31 |
|
