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IEC 60601-2-28:2017 RLV

Current
Current

The latest, up-to-date edition.

Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis
Available format(s)

Hardcopy , PDF 1 User , PDF 3 Users , PDF 5 Users , PDF 9 Users

Language(s)

English

Published date

16-06-2017

FOREWORD
201.1 Scope, object and related standards
201.2 Normative references
201.3 Terms and definitions
201.4 General requirements
201.5 General requirements for testing ME EQUIPMENT
201.6 Classification of ME EQUIPMENT and ME SYSTEMS
201.7 ME EQUIPMENT identification, marking and documents
201.8 Protection against electrical HAZARDS from ME
       EQUIPMENT
201.9 Protection against MECHANICAL HAZARDS of ME
       EQUIPMENT and ME SYSTEMS
201.10 Protection against unwanted and excessive RADIATION
       HAZARDS
201.11 Protection against excessive temperatures and other
       HAZARDS
201.12 Accuracy of controls and instruments and protection
       against hazardous outputs
201.13 HAZARDOUS SITUATIONS and fault conditions for ME
       EQUIPMENT
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS
       (PEMS)
201.15 Construction of ME EQUIPMENT
201.16 ME SYSTEMS
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME
       SYSTEMS
203 RADIATION protection in diagnostic X-RAY EQUIPMENT
Annexes
Annex AA (informative) - Test of X-RAY TUBE ASSEMBLIES
         for expelled parts-related and/or tube
         implosion-related RISKS
Bibliography
Index of defined terms used in this particular standard

IEC 60601-2-28:2017 RLV contains both the official IEC International Standard and its Redline version. The Redline version is available in English only and provides you with a quick and easy way to compare all the changes between the official IEC Standard and its previous edition.

IEC 60601-2-28:2017 applies to the basic safety and essential performance of X-ray tube assemblies and to components thereof, intended for medical diagnosis and imaging. Where the general standard IEC 60601-1 and the collateral standard IEC 60601-1-3 refer to me equipment, this is interpreted as X-ray tube assemblies in this particular standard. If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME equipment and to ME systems, as relevant. The third edition of this particular standard has been prepared to fit IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012 (the amended third edition of IEC 60601-1), which is referred to as the general standard. Apart from the changes related to the amendment of IEC 60601-1, changes related to technical improvements are also included.

Committee
TC 62/SC 62B
DevelopmentNote
Stability Date: 2022. (06/2017)
DocumentType
Redline
Pages
73
PublisherName
International Electrotechnical Committee
Status
Current
Supersedes

Standards Relationship
AS/NZS IEC 60601.2.28:2015 Identical

IEC 60336:2005 Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Characteristics of focal spots
ISO 13732-1:2006 Ergonomics of the thermal environment — Methods for the assessment of human responses to contact with surfaces — Part 1: Hot surfaces
IEC 60522:1999 Determination of the permanent filtration of X-ray tube assemblies
IEC TR 60788:2004 Medical electrical equipment - Glossary of defined terms
IEC 60601-1-10:2007+AMD1:2013 CSV Medical electrical equipment - Part 1-10: General requirements forbasic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loopcontrollers
IEC 60613:2010 Electrical and loading characteristics of X-ray tube assemblies for medical diagnosis
IEC 60601-1-3:2008+AMD1:2013 CSV Medical electrical equipment - Part 1-3: General requirements forbasic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
IEC 61010-1:2010+AMD1:2016 CSV Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements
IEC 60601-1-9:2007+AMD1:2013 CSV Medical electrical equipment - Part 1-9: General requirements forbasic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design

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