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BS EN 60601-2-28:2010

Superseded

Superseded

View Superseded by

Medical electrical equipment Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

07-31-2010

Superseded date

09-27-2019

US$333.50
Excluding Tax where applicable
Summarise this standard

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
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
         pressure-related RISKS
Index of defined terms used in this particular standard
Annex ZA (normative) - Normative references to international
         publications with their corresponding European
         publications
Annex ZZ (informative) - Coverage of Essential Requirements
         of EC Directives

Pertains to the BASIC SAFETY and ESSENTIAL PERFORMANCE of X-RAY TUBE ASSEMBLIES and to components thereof: - hereafter referred to as ME EQUIPMENT; - intended for medical diagnosis and imaging.

Committee
CH/62/2
DevelopmentNote
Supersedes 92/55427 DC. (11/2005) To be read in conjunction with BS EN 60601-1. Supersedes BS 5724-2.128(1993). Supersedes 08/30176368 DC. (07/2010)
DocumentType
Standard
Pages
24
PublisherName
British Standards Institution
Status
Superseded
SupersededBy
Supersedes

IEC 60601-2-28:2010 establishes particular basic safety and essential performance requirements for X-ray tube assemblies for medical diagnosis. This second edition cancels and replaces the first edition published in 1993. This edition constitutes a technical revision. The second edition of this particular standard has been prepared to fit IEC 60601-1:2005 (the third edition of IEC 60601-1), which is referred to as the general standard.

Standards Relationship
DIN EN 60601-2-28 : 2010 Identical
I.S. EN 60601-2-28:2010 Identical
EN 60601-2-28:2010 Identical
IEC 60601-2-28:2010 Identical
IEC 60601-2-28:2017 Identical
EN 62304:2006 Identical
UNE-EN 60601-2-28:2010 Equivalent
UNE-EN 60601-2-28:1996 Identical

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US$333.50
Excluding Tax where applicable