DANSK DSF/IEC TR 60601-4-3 ED2 PDF

This document contains a series of recommendations developed by an expert working group of IEC subcommittee 62A in response to questions of interpretation of the third edition of IEC 60601-1 and related collateral standards in the IEC 60601 series . This technical report is primaril y intended to be used by: – MANUFACTURERS of MEDICAL ELECTRICAL E QUIPMENT; – 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 606 01- 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 revision s of IEC 60601-1 and related collateral standards in the IEC 60601 series . 1.2 Object The object of this document is to make the recommendations/interpretatio ns developed by the experts in IEC/SC 62A/W G 14 available to those interested in the application of the third edition of IEC 60601- 1 and applicable collater al standards. NOTE – There m ight be ot her acceptabl e soluti ons which are not refl ected i n this docum ent . The reader is reminded that, although a majority of the National Committee members of IEC/SC 62A have approved publication of this technical report, the contents remain the opinion of the expert members of W G 14. These recommendations/interpretations are the result of considerations by this group of nominated experts and have not been formally adopted through any National Committee voting procedure. Distribution is only for information.