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I.S. EN 60601-2-64:2015

Current
Current

The latest, up-to-date edition.

MEDICAL ELECTRICAL EQUIPMENT - PART 2-64: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF LIGHT ION BEAM MEDICAL ELECTRICAL EQUIPMENT
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2015

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For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.

Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

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
       for ME EQUIPMENT
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
201.101 ELECTRONIC IMAGING DEVICES (EID)
206 Usability
Annexes
Annex B (informative) - Sequence of testing
Annex I (informative) - ME SYSTEMS aspects
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 Light Ion Beam Medical Electrical equipment, hereafter referred to as ME equipment, used for treatment of patients.

DevelopmentNote
For CENELEC adoptions of IEC publications, please check www.iec.ch to be sure that you have any corrigenda that may apply. (01/2017)
DocumentType
Standard
Pages
126
PublisherName
National Standards Authority of Ireland
Status
Current

Standards Relationship
EN 60601-2-64:2015 Identical

EN 61217:2012 Radiotherapy equipment - Coordinates, movements and scales
EN 60601-2-11:2015 Medical electrical equipment - Part 2-11: Particular requirements for the basic safety and essential performance of gamma beam therapy equipment
IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC TR 60788:2004 Medical electrical equipment - Glossary of defined terms
ISO/IEC 14165-321:2009 Information technology Fibre Channel Part 321: Audio-Video (FC-AV)
IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
EN 60601-1-2:2015 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
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 61217:2011 Radiotherapy equipment - Coordinates, movements and scales
IEC 60601-2-11:2013 Medical electrical equipment - Part 2-11: Particular requirements for the basic safety and essential performance of gamma beam therapy equipment

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