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

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

Status : Current   Published : January 2019

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What is this standard about?

This part of IEC 60601, which is a Technical Report, 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.

This document 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 this document 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.




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
StatusCurrent
Publication Date04 January 2019
Normative References(Required to achieve compliance to this standard)IEC 60747-5-5:2007, IEC 62304:2006, ISO 14971:2000, IEC 62304:2006/AMD1:2015, IEC 60529:1989/AMD2:2013, IEC 60601-1-8:2006/AMD1:2012, IEC 60529:1989/AMD1:1999, IEC 60601-1-11:2015, IEC 60601-1:2005, IEC 60601-1-11:2010, IEC 60601-1-12:2014, IEC 60601-1-8:2006, ISO 8820-3:2010, IEC 60950-1:2005, IEC 60601-1:2005/AMD1:2012, IEC 60529:1989 Cons Ed 2-1, IEC 60601-1-2:2014, ISO 14971:2007, IEC 60332-1-2, IEC 60332-2-2, UL 1642:2012, IEC 62133
Informative References(Provided for Information)ISO 10993 (all parts), IEC 60228, ISO 13732-1, IEC 60601-2-4, ISO/IEC Guide 51, IEC 60601-2-28, IEC 61010-1, IEC 60747-1, ISO 8596, IEC 60601-2-54, IEC 60601-2-44, IEC 62353, IEC TS 60479-2, IEC 61010 (all parts), IEC 60086-4, ISO 80001-1, IEC 60825-1, IEC 60695-10-2, IEC 60601-2-2, ISO 7010, IEC 60695-11-10, ISO 15223-1, UL 2556:2007, IEC 60601-2-36, IEC 60252-1, IEC 60799, IEC 60065, IEC 60601-2-46, IEC 60664 (all parts), IEC 60384-14, IEC 60309, IEC 60079-11, IEC 60601-2-22, 93/42/EEC, IEC 60127-1, IEC 80601-2-60, IEC 60747-2, IEC 60601-2-50, UL 796, IEC 60747-3, IEC 62471:2006, IEC 62368-1:2014, ISO 11070:2014, IEC 60601-2-18:2009, IEC 62368-1:2010, IEC 60335-1:2010, IEC 62366:2007, IEC 60664-1:2007, UL 2556:2007 Ed 2, ISO 10993-1:2009, IEC 60601-2-49:2011, IEC 60695-11-5:2004, IEC 60073:2002, IEC 62366:2007/AMD1:2014, IEC TR 62296:2009, ISO 80601-2-13:2011
ReplacesPD IEC/TR 60601-4-3:2015
International RelationshipsIEC 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
CommitteeCH/62/1
ISBN978 0 580 96530 2
PublisherBSI
FormatA4
DeliveryYes
Pages146
File Size1.634 MB
Price£328.00


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