Publication CODE |
Title |
IEC TR 60601-4-3:2018 (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 |
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Price Excl. VAT |
Total number of pages, tables and drawings |
424.00 €
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144. |
Description
IEC TR 60601-4-3:2018 is available as IEC TR 60601-4-3:2018 RLV 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.
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Class |
C990
(IEC PUBLICATIONS IEC PUBLICATIONS)
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Committee |
TC 62/SC 62A
COMMON ASPECTS OF ELECTRICAL EQUIPMENT USED IN MEDICAL PRACTICE
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Responsible |
De heer VAN HECKE Luk
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BEC Approval |
2018-12-13 |
ICS-Code (International Standards Classification) |
11.040.01
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NBN Status |
New |
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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 |
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