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I.S. EN 60601-2-17:2015

Current

Current

The latest, up-to-date edition.

MEDICAL ELECTRICAL EQUIPMENT - PART 2-17: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AUTOMATICALLY CONTROLLED BRACHYTHERAPY AFTERLOADING EQUIPMENT

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2015

Preview

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.

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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 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
Annex A (informative) - General guidance and rationale
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 automatically-controlled BRACHYTHERAPY AFTERLOADING ME EQUIPMENT, hereafter referred to as ME EQUIPMENT.

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
106
PublisherName
National Standards Authority of Ireland
Status
Current

Standards Relationship
UNE-EN 60601-2-17:2005 Identical
SN EN 60601-2-17 : 1996 AMD 1 1996 Identical
BS EN 60601-2-17:2015 Identical
EN 60601-2-17:2015 Identical
NF EN 60601-2-17 : 2015 Identical

EN 60601-2-8:2015/A1:2016 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)
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
IEC 61005:2014 Radiation protection instrumentation - Neutron ambient dose equivalent (rate) meters
EN 61005:2017 Radiation protection instrumentation - Neutron ambient dose equivalent (rate) meters
IEC 60601-2-8:2010+AMD1:2015 CSV Medical electrical equipment - Part 2-8: Particular requirements forthe basic safety and essential performance of therapeutic X-ray equipment operating in the range 10 kV to 1 MV
IEC 62083:2009 Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning systems
IEC 60601-2-28:2017 Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis
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
EN 62083:2009 MEDICAL ELECTRICAL EQUIPMENT - REQUIREMENTS FOR THE SAFETY OF RADIOTHERAPY TREATMENT PLANNING SYSTEMS
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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