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  • BSI
    PD IEC/TR 60601-4-3:2018 Medical electrical equipment - Guidance and interpretation. Considerations of unaddressed safety aspects in the third edition of IEC 60601-1 and proposals for new requirements
    Edition: 2019
    $569.57
    / user per year

Description of PD IEC/TR 60601-4-3:2018 2019

IEC TR 60601-4-3:2018 is available as /2 which contains the International Standard and its Redline version, showing all changes of the technical content compared to the 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.

Standard NumberPD IEC/TR 60601-4-3:2018
TitleMedical electrical equipment - Guidance and interpretation. Considerations of unaddressed safety aspects in the third edition of IEC 60601-1 and proposals for new requirements
StatusDefinitive
Publication Date2019-01-04
ReplacesPD IEC/TR 60601-4-3:2015
Identical National Standard OfIEC TR 60601-4-3:2018
DescriptorsMedical equipment, Heart, Electrical medical equipment, Safety measures, Electronic equipment and components, Monitors, Electrical safety, Defibrillators, Medical instruments, Electrical equipment, Cardiology, Safety engineering
ICS11.040.01 Medical equipment in general
CommitteeCH/62/1
ISBN978 0 580 96530 2
PublisherBSI
Pages146

About BSI

BSI Group, also known as the British Standards Institution is the national standards body of the United Kingdom. BSI produces technical standards on a wide range of products and services and also supplies certification and standards-related services to businesses.
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