Norm

IEC/TR 60601-4-3:2018-RL en

Medische elektrische toestellen - Deel 4-3: Begeleiding en interpretatie - Overweging van ongeadresseerde veiligheidsaspecten in de derde editie van IEC 60601-1 en voorstellen voor nieuwe eisen (Redline versie met track changes)

359,78 435,33 Incl BTW

Over deze norm

Status Definitief
Aantal pagina's 298
Commissie Medische elektrische toestellen
Gepubliceerd op 01-12-2018
Taal Engels
IEC 60601-4-3, 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. - THIS REDLINE VERSION PROVIDES YOU WITH QUICK AND EASY WAY TO COMPARE ALL THE CHANGES BETWEEN THIS STANDARD AND ITS PREVIOUS EDITION. A VERTICAL BAR APPEARS IN THE MARGIN WHEREVER A CHANGE HAS BEEN MADE. ADDITIONS AND DELETIONS ARE DISPLAYED IN RED, WITH DELETIONS BEING STRUCK THROUGH.

Details

ICS-code 11.040.01
Nederlandse titel Medische elektrische toestellen - Deel 4-3: Begeleiding en interpretatie - Overweging van ongeadresseerde veiligheidsaspecten in de derde editie van IEC 60601-1 en voorstellen voor nieuwe eisen (Redline versie met track changes)
Engelse titel 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 (Redline version with track changes)

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