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08/30176368 DC : 0

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

BS EN 60601-2-28 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-28: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY TUBE ASSEMBLIES FOR MEDICAL DIAGNOSIS
Available format(s)

Hardcopy , PDF

Superseded date

07-31-2010

Language(s)

English

FOREWORD
INTRODUCTION
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 of 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
202 Medical electrical equipment - Part 1-2: General
        requirements for safety - Collateral standard:
        Electromagnetic compatibility - Requirements and tests
203 Medical electrical equipment - Part 1: General
        requirements for safety - 3. Collateral standard:
        General requirements for RADIATION protection in
        diagnostic X-ray equipment
206 Medical electrical equipment - Part 1-6: General
        requirements for safety - Collateral standard:
        Usability
208 Medical electrical equipment - Part 1-8: General
        requirements for safety - Collateral Standard: General
        requirements, tests and guidance for alarm systems in
        medical electrical equipment and medical electrical systems
209 Medical electrical equipment - Part 1-9: General requirements
        for basic safety and essential performance - Collateral
        Standard: Requirements for the reduction of environmental
        impacts
210 Medical electrical equipment - Part 1-10: General requirements
        for basic safety and essential performance - Collateral
        Standard: Process requirements for the development of
        therapeutic closed-loop controllers
211 Medical electrical equipment - Part 1-11: General
        requirements for basic safety and essential performance
        - Collateral Standard: Requirements for medical electrical
        equipment and medical electrical system used in the home
        healthcare environment
Annex BB (informative) - Test of X-RAY TUBE ASSEMBLIES for
         pressure-related risks
  BB.1 Introduction
  BB.2 General considerations
  BB.3 General start-conditions for the typical tests
  BB.4 Disintegration inducement for glass-metal X-RAY TUBES
  BB.5 Disintegration inducement for metal-ceramic X-RAY TUBES
  BB.6 Pass/fail criteria
INDEX OF DEFINED TERMS USED IN THIS PARTICULAR STANDARDô

BS EN 60601-2-28

Committee
CH/62/2
DocumentType
Draft
Pages
22
PublisherName
British Standards Institution
Status
Superseded
SupersededBy

IEC 60336:2005 Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Characteristics of focal spots
IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
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 60601-1-6:2010+AMD1:2013 CSV Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
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 60601-1-8:2006+AMD1:2012 CSV Medical electrical equipment - Part 1-8: General requirements forbasic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems inmedical electrical equipment and medical electrical systems
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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