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Publication details

Publication CODE Title
IEC TR 60601-4-3:2018 RLV (2018-12) MEDICAL ELECTRICAL EQUIPMENT - PART 4-3: GUIDANCE AND INTERPRETATION - CONSIDERATIONS OF UNADDRESSED SAFETY ASPECTS in THE THIRD EDITION OF IEC 60601-1 AND PROPOSALS FOR NEW REQUIREMENTS
 
Price Excl. VAT Total number of pages, tables and drawings
551.00 € 298.
Description
IEC TR 60601-4-3:2018 RLV contains both the official IEC International Standard and its Redline version. The Redline version is not an official document, it is available in English only and provides you with a quick and easy way to compare all the changes between the official IEC Standard and its previous edition.

IEC TR 60601-4-3:2018 contains a series of recommendations developed by an expert working group of IEC subcommittee 62A in response to questions of interpretation of IEC 60601-1:2005 and related collateral standards in the IEC 60601 series. IEC TR 60601-4-3:2018 is primarily intended to be used by:
- manufacturers of medical electrical equipment;
- test laboratories and others responsible for assessment of compliance with IEC 60601 1:2005,  IEC 60601-1:2005/AMD1:2012, IEC 60601-1-8:2006, IEC 60601-1-8:2006/AMD1:2012, IEC 60601-1-11:2010, IEC 60601 1 11:2015 and IEC 60601-1-12:2014;
- those developing subsequent editions of IEC 60601-1.
The recommendations in the first edition of IEC TR 62296 were considered in preparing the third edition of IEC 60601-1. Similarly, it is expected that these recommendations within IEC 60601-4-3 will be considered when preparing future revisions of IEC 60601-1 and related collateral standards in the IEC 60601 series. The object of IEC TR 60601-4-3:2018 is to make the recommendations/interpretations available to those interested in the application of the third edition of IEC 60601-1 and applicable collateral standards. IEC TR 60601-4-3:2018 cancels and replaces the first edition of IEC 60601-4-3 published in 2015. This edition constitutes a technical revision. IEC TR 60601-4-3:2018 includes the following significant technical changes with respect to the previous edition: addition of 47 new recommendations.
Class  C990  (IEC PUBLICATIONS IEC PUBLICATIONS)
Available files
EN 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 2018-12-13
ICS-Code (International Standards Classification) 11.040.01
NBN Status New
IEC publication date 2018-12-13
IEC stability date 2022-12-31
IEC file modification date 2018-12-13
IEC last modification date 2019-10-31