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EN 60601-2-8:2015/A1:2016

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Current

The latest, up-to-date edition.

MEDICAL ELECTRICAL EQUIPMENT - PART 2-8: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF THERAPEUTIC X-RAY EQUIPMENT OPERATING IN THE RANGE 10 KV TO 1 MV (IEC 60601-2-8:2010/A1:2015)
Amendment of

EN 60601-2-8:2015

Published date

01-08-2016

Publisher

European Committee for Standards - Electrical

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
Bibliography
Index of defined terms used in this particular standard
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 therapeutic X-RAY EQUIPMENT with NOMINAL X-RAY TUBE VOLTAGES in the range 10 kV to 1 MV when connected to alternating current SUPPLY MAINS, hereafter referred to as ME EQUIPMENT.

Committee
TC 62
DevelopmentNote
To be read in conjunction with EN 60601-1. (05/2001) Supersedes HD 395.2.8. (06/2005)
DocumentType
Standard
PublisherName
European Committee for Standards - Electrical
Status
Current
Supersedes

CEI EN 60731 : 2012 MEDICAL ELECTRICAL EQUIPMENT - DOSIMETERS WITH IONIZATION CHAMBERS AS USED IN RADIOTHERAPY
I.S. EN 60601-2-17:2015 MEDICAL ELECTRICAL EQUIPMENT - PART 2-17: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AUTOMATICALLY CONTROLLED BRACHYTHERAPY AFTERLOADING EQUIPMENT
BS EN 60731:2012 Medical electrical equipment. Dosimeters with ionization chambers as used in radiotherapy
CEI EN 60601-2-17 : 2016 MEDICAL ELECTRICAL EQUIPMENT - PART 2-17: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AUTOMATICALLYCONTROLLED BRACHYTHERAPY AFTERLOADING EQUIPMENT
BS EN 60601-2-17:2015 Medical electrical equipment Particular requirements for the basic safety and essential performance of automatically-controlled brachytherapy afterloading equipment
I.S. EN 60731:2012 MEDICAL ELECTRICAL EQUIPMENT - DOSIMETERS WITH IONIZATION CHAMBERS AS USED IN RADIOTHERAPY (IEC 60731:2011 (EQV))
EN 60731:2012 Medical electrical equipment - Dosimeters with ionization chambers as used in radiotherapy
EN 60601-2-17:2015 Medical electrical equipment - Part 2-17: Particular requirements for the basic safety and essential performance of automatically-controlled brachytherapy afterloading equipment

EN 61217:2012 Radiotherapy equipment - Coordinates, movements and scales
IEC TR 60788:2004 Medical electrical equipment - Glossary of defined terms
IEC 60601-2-1:2009+AMD1:2014 CSV 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
IEC 60601-2-17:2013 Medical electrical equipment - Part 2-17: Particular requirements for the basic safety and essential performance of automatically-controlled brachytherapy afterloading equipment
IEC 61217:2011 Radiotherapy equipment - Coordinates, movements and scales
ISO/IEC Guide 98-3:2008 Uncertainty of measurement — Part 3: Guide to the expression of uncertainty in measurement (GUM:1995)

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