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CEI EN 60601-2-1 : 2016

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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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Superseded date

14-05-2022

Language(s)

English

Published date

01-01-2016

€152.15
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
Annex ZA (normative) - Normative references to international
         publications with their corresponding European
         publications
Annex ZZ (informative) - Coverage of Essential Requirements
         of EU Directives

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
CT 62
DevelopmentNote
Classificazione CEI 62-35 (08/2001) 2ED 2000 Edition along with its amendment is valid until 15-09-2018. (05/2016)
DocumentType
Standard
Pages
76
PublisherName
Comitato Elettrotecnico Italiano
Status
Superseded
SupersededBy

Standards Relationship
IEC 60601-2-1:2009+AMD1:2014 CSV Identical
EN 60601-2-1:2015 Identical

EN 61217:2012 Radiotherapy equipment - Coordinates, movements and scales
IEC TR 60788:2004 Medical electrical equipment - Glossary of defined terms
IEC 61217:2011 Radiotherapy equipment - Coordinates, movements and scales

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