EN 60601-2-28:2010
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis
07-05-2010
03-02-2022
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
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
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.
| Committee |
CLC/TC 62
|
| DevelopmentNote |
To be read in conjunction with EN 60601-1:1990 and EN 60601-1-3:1994 (05/2001)
|
| DocumentType |
Standard
|
| PublisherName |
European Committee for Standards - Electrical
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| NBN EN 60601 2-28 : 2010 | Identical |
| NEN 10601-2-28 : 1993 | Identical |
| NEN EN IEC 60601-2-28 : 2010 | Identical |
| I.S. EN 60601-2-28:2010 | Identical |
| PN EN 60601-2-28 : 2010 | Identical |
| DIN EN 60601-2-28 : 2010 | Identical |
| VDE 0750-2-28 : 2010 | Identical |
| BS EN 60601-2-28:2010 | Identical |
| CEI EN 60601-2-28 : 2011 | Identical |
| NF EN 60601 2-28 : 2011 | Identical |
| IEC 60601-2-28:2017 | Identical |
| UNE-EN 60601-2-28:2010 | Identical |
| BS EN 61158-3-13:2014 | Identical |
| UNE-EN 60601-2-28:1996 | Identical |