BS 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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis
Hardcopy , PDF
27-09-2019
English
31-07-2010
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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Superseded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 |
| SN EN 60601-2-28 : 1993 | Identical |
| UNE-EN 60601-2-28:1996 | Identical |
| EN 60601-2-28:2010 | Identical |
| IEC 60601-2-28:2010 | Identical |
| IEC 60601-2-28:2017 | Identical |
| BS 7725-3.2(1997) : 1997 | EVALUATION AND ROUTINE TESTING IN MEDICAL IMAGING DEPARTMENTS - CHEMICAL METHODS - IMAGING PERFORMANCE OF MAMMOGRAPHIC X-RAY EQUIPMENT |
| EN 60613:2010 | Electrical and loading characteristics of X-ray tube assemblies for medical diagnosis |
| IEC 60336:2005 | Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Characteristics of focal spots |
| EN 60601-1-3 : 2008 AMD 11 2016 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-3: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: RADIATION PROTECTION IN DIAGNOSTIC X-RAY EQUIPMENT (IEC 60601-1-3:2008/A1:2013) |
| 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 60613:2010 | Electrical and loading characteristics of X-ray tube assemblies for medical diagnosis |
| EN 60522:1999 | Determination of the permanent filtration of X-ray tube assemblies |
| EN 60336:2005 | Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Characteristics of focal spots |
| 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 |
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