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Publication details

Publication CODE Title
IEC 60601-1-6:2010+AMD1:2013+AMD2:2020 CSV (2020-07) MEDICAL ELECTRICAL EQUIPMENT - PART 1-6: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: USABILITY
 
Price Excl. VAT Total number of pages, tables and drawings
355.00 € 93.
Description
IEC 60601-1-6:2010+A1:2013+A2:2020 specifies a process for a manufacturer toanalyse, specify, design, verify and validate usability, as it relates to basic safety and essential performance of medical electrical equipment. This usability engineering process assesses and mitigates risks caused by usability problems associated with correct use and use errors, i.e., normal use. It can be used to identify but does not assess or mitigate risks associated with abnormal use. If the usability engineering process detailed in this collateral standard has been complied with and the acceptance criteria documented in the usability validation plan have been met (see 5.9 of IEC 62366:2007), then the residual risks, as defined in ISO 14971, associated with usability of me equipment are presumed to be acceptable, unless there is objective evidence to the contrary (see 4.1.2 of IEC 62366:2007). The object of this collateral standard is to specify general requirements that are in addition to those of the general standard and to serve as the basis for particular standards. This document cancels and replaces the second edition of IEC 60601-1-6 which has been technically revised. It was revised to align with the usability engineering process in IEC 62366. To allow for equipment manufacturers and testing organizations to make products and to equip themselves for conducting revised tests in accordance with this third edition, it is recommended by SC 62A that the content of this document not be adopted for mandatory implementation earlier than 3 years from the date of publication for equipment newly designed and not earlier than 5 years from the date of publication for equipment already in production. This consolidated version consists of the third edition (2010), its amendment 1 (2013) and its amendment 2 (2020). Therefore, no need to order amendments in addition to this publication.
Class  C990  (IEC PUBLICATIONS IEC PUBLICATIONS)
Available files
EN/FR version

Status
Status IEC PUBLICATION
Situation Currently active
Origin
Committee TC 62/SC 62A
COMMON ASPECTS OF ELECTRICAL EQUIPMENT USED IN MEDICAL PRACTICE
Responsible De heer VAN HECKE Luk
Approval
BEC Approval 2020-07-22
ICS-Code (International Standards Classification) 11.040.01
NBN Status New
IEC publication date 2020-07-22
IEC stability date 2024-12-31
IEC file modification date 2020-07-22
IEC last modification date 2020-07-22