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CSA C22.2 No. 60601.2.1 : 2011 : INC : AMD 1 : 2015 : R2016

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 2-1: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF ELECTRON ACCELERATORS IN THE RANGE 1 MEV TO 50 MEV

Available format(s)

Hardcopy , PDF

Superseded date

25-09-2021

Language(s)

English - French

Published date

01-01-2016

€34.10
Excluding VAT

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 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
206 Usability
Annexes
Annex B (informative) - Sequence of testing
Annex I (informative) - ME SYSTEMS aspects
Bibliography
Index of defined terms

Pertains to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ELECTRON ACCELERATORS, hereafter referred to as ME EQUIPMENT, in the range 1 MeV to 50 MeV, used for treatment of PATIENTS.

Committee
TC 62
DevelopmentNote
Amendment 1 is available separately, see CSA C22.2.60601.2.1A. (12/2015)
DocumentType
Standard
ISBN
978-1-55491-673-3
Pages
15
ProductNote
Reconfirmed EN
PublisherName
Canadian Standards Association
Status
Superseded

IEC TR 60788:2004 Medical electrical equipment - Glossary of defined terms
IEC 60976:2007 Medical electrical equipment - Medical electron accelerators - Functional performance characteristics
IEC 62366:2007+AMD1:2014 CSV Medical devices - Application of usability engineering to medical devices
IEC TR 60977:2008 Medical electrical equipment - Medical electron accelerators - Guidelines for functional performance characteristics
IEC 61217:2011 Radiotherapy equipment - Coordinates, movements and scales

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