MEDICAL ELECTRICAL EQUIPMENT - PART 2-11: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF GAMMA BEAM THERAPY EQUIPMENT

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2016

Publisher

Comitato Elettrotecnico Italiano

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
Annexes
Annex B (informative) - Sequence of testing
Index of defined terms used in this particular standard
Annex ZA (normative) - Normative references to international
         publications with their corresponding European
         publications

Pertains to the BASIC SAFETY and ESSENTIAL PERFORMANCE of GAMMA BEAM THERAPY EQUIPMENT, including MULTI-SOURCE STEREOTACTIC RADIOTHERAPY equipment, hereafter referred to as ME EQUIPMENT.

Committee	CT 62
DevelopmentNote	Classificazione CEI 62-31 (08/2001) 2ED 1998 Edition along with its amendment is valid until 14-04-2018. (02/2016)
DocumentType	Standard
Pages	56
PublisherName	Comitato Elettrotecnico Italiano
Status	Current
Supersedes	CEI 62-31 : 1ED 1990

Standards	Relationship
IEC 60601-2-11:2013	Identical
EN 60601-2-11:2015	Identical

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

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CEI EN 60601-2-11 : 2016

MEDICAL ELECTRICAL EQUIPMENT - PART 2-11: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF GAMMA BEAM THERAPY EQUIPMENT

Table of Contents

Abstract

General Product Information

International Equivalents

Standards Referencing This Book

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