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CSA C22.2 No. 60601-2-28 : 2012

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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

Superseded date

07-29-2021

Language(s)

English

Published date

01-01-2016

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

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

DevelopmentNote
Supersedes CSA C22.2.601.2.28. (04/2012)
DocumentType
Standard
Pages
62
ProductNote
Reconfirmed EN
PublisherName
Canadian Standards Association
Status
Superseded
SupersededBy

IEC 60336:2005 Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Characteristics of focal spots
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
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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